Online Positive Affect Journaling in the Improvement of Mental Distress and Well-Being in General Medical Patients With Elevated Anxiety Symptoms: A Preliminary Randomized Controlled Trial

Background Positive affect journaling (PAJ), an emotion-focused self-regulation intervention, has been associated with positive outcomes among medical populations. It may be adapted for Web-based dissemination to address a need for scalable, evidence-based psychosocial interventions among distressed patients with medical conditions. Objective This study aimed to examine the impact of a 12-week Web-based PAJ intervention on psychological distress and quality of life in general medical patients. Methods A total of 70 adults with various medical conditions and elevated anxiety symptoms were recruited from local clinics and randomly assigned to a Web-based PAJ intervention (n=35) or usual care (n=35). The intervention group completed 15-min Web-based PAJ sessions on 3 days each week for 12 weeks. At baseline and the end of months 1 through 3, surveys of psychological, interpersonal, and physical well-being were completed. Results Patients evidenced moderate sustained adherence to Web-based intervention. PAJ was associated with decreased mental distress and increased well-being relative to baseline. PAJ was also associated with less depressive symptoms and anxiety after 1 month and greater resilience after the first and second month, relative to usual care. Conclusions Web-based PAJ may serve as an effective intervention for mitigating mental distress, increasing well-being, and enhancing physical functioning among medical populations. PAJ may be integrated into routine medical care to improve quality of life. Trial Registration ClinicalTrials.gov NCT01873599; https://clinicaltrials.gov/ct2/show/NCT01873599 (Archived by WebCite at http://www.webcitation.org/73ZGFzD2Z)

Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 1a) Does your paper address CONSORT item 1a? * Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: Online positive affect journaling 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: content speci city -positive affect journaling.
1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: general medical patients Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: Seventy adults with various medical conditions were randomly assigned to an online PAJ intervention (n=35) or usual care (n=35). The intervention group completed 15-minute online PAJ sessions on three days each week for 12 weeks. At baseline and the end of months 1 through 3, surveys of psychological, interpersonal, and physical well-being were completed.
1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: assigned to an online PAJ intervention 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials  [46,47]. As such, the expressive writing paradigm has been adapted to have participants write about positive aspects of their lives and themselves (e.g., making meaning out of or nding bene t in past experiences; [48,49]; focusing on positive aspects of one's self [50]) under the notion that this would yield similar bene ts to those observed in the positive psychology literature. As a whole, we refer to this array of positive-focused writing approaches as PAJ.
Positive affect interventions among both patients and healthy individuals have led to improvements in a number of health outcomes. In two studies comparing an education control (i.e., educational workbook and behavioral contract) to a positive affect intervention (i.e., self-a rmation inducement over bi-monthly telephone sessions with staff and unexpected gifts prior to calls), positive affect improved medication adherence in hypertensive African American patients [51], and physical activity in patients following a percutaneous coronary procedure [52]. In addition, Stanton and colleagues [53] found that four sessions of written expressive disclosure or bene t nding resulted in lower physical symptom reports and medical appointments among breast cancer patients at 3month follow-up. In healthy samples, Armitage and colleagues [54] found bene cial effects of completing a self-a rmation questionnaire or self-a rming implementation intention on alcohol intake at one-month follow-up, while Burton and King [55] observed that participants randomized to write only two minutes for two consecutive days in a lab about a recent positive event showed moderate reductions in physical symptoms (Cohen's d=.65) at 4 to 6-week follow-up. 2b) In INTRODUCTION: Speci c objectives or hypotheses METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: The goal of this randomized controlled trial was to examine whether a 12-week internet-based PAJ intervention could reduce mental distress (primary outcome) and positively in uence psychological, interpersonal, and physical well-being (secondary outcomes), relative to usual care, in a heterogeneous sample of patients with elevated anxiety symptoms. It was hypothesized that participants randomized to the intervention would experience decreases in mental distress (i.e., Hospital Anxiety and Depression Scale score; HADS) and improvements in psychological well-being (e.g., perceived stress, resilience), interpersonal wellbeing (i.e., social support), and physical well-being (e.g., days during which pain inhibited usual activities) over the 12-week intervention period. It was also hypothesized that participants randomized to receive the intervention would report less mental distress and greater levels of psychological, interpersonal, and physical well-being than those in the control condition at each assessment period.
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: Randomization (1:1) was done via sealed envelopes prepared by someone other than the research staff conducting the study visits and opened by participants during the baseline visit after completing informed consent.
During the baseline visit, all participants completed baseline surveys and were randomized (via sealed envelopes) to one of the two conditions. Participants assigned to the intervention condition received an introduction and training session to orient them to the intervention website where they would complete the writing sessions. All participants completed self-report survey assessments online at the end of months 1, 2, and 3 using a secure data capture system (REDCap). Participants received gift cards following the completion of each survey (i.e., $40 compensation for completing all three assessments). Intervention Participants in the PAJ intervention condition were asked to complete online writing sessions for 15 minutes on three days each week for the duration of the 12-week study. The amount of time spent writing is similar to those used in prior expressive writing studies, although the duration of the intervention in this study was longer than other prior studies [23,25,59]. During each online writing session, participants logged onto the study website and wrote a journal entry on one of seven commonly used positive affect prompts (e.g., What are you thankful for? What did someone else do for you?) [60]; all entries were saved on a secure server. During the study, journal entries of participants in the intervention condition were screened by research staff to monitor content. As there is no clinical standard of care treatment for medical patients with mild to moderate anxiety symptoms, participants randomized to the control group received their usual care for the duration of the study. After they had completed all study procedures, participants in the control condition were given access to the PAJ intervention. 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Potential participants were recruited through yers placed around the PSHMC campus and advertisements placed in PSHMC media and local community newspapers in central Pennsylvania. Additionally, oncology patients at The Pennsylvania State University Hershey Cancer Institute with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-3 (not completely disabled) were identi ed through registry review and sent a letter describing the study. Participants were provided with a toll-free number to call if they were interested in participating, as well as an opt-out card that could be mailed back by those who were uninterested. Individuals who did not respond were contacted via phone by a research staff member within two weeks to determine their interest in participating.

3b-i) Bug xes, Downtimes, Content Changes
Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No meaningful downtime or bugs; simple web-interface delivery.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Eligibility for inclusion was based on: (1) English uency, (2) between 21 and 80 years of age, (3) internet access, (4) self-report of moderate to signi cant stress during the past month, (5) not currently pregnant and no plans to become pregnant within the next 3 months, (6) no plans to move within the next 6 months, (7) no hospitalization for a psychiatric condition in the past year, (8)  Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Although not an explicit requirement, it was assumed that potential participants be familiar with using a computer and accessing web-sites.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants were provided with a toll-free number to call if they were interested in participating, as well as an opt-out card that could be mailed back by those who were uninterested. Individuals who did not respond were contacted via phone by a research staff member within two weeks to determine their interest in participating.

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study ... sent a letter describing the study.
Eligible participants met with research staff during a scheduled baseline visit to discuss study procedures and provide written informed consent.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: Online 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: All participants completed self-report survey assessments online at the end of months 1, 2, and 3 using a secure data capture system (REDCap).

4b-ii) Report how institutional a liations are displayed
Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 5) The interventions for each group with su cient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes; institutional a liations were apparent.

5-i) Mention names, credential, a liations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Developed by authors.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes; this is rst test, so de novo implementation being described.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This was the rst version tested of this intervention; the intervention content was 'frozen' during the trial and not adjusted.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study During the study, journal entries of participants in the intervention condition were screened by research staff to monitor content.

5-v)
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes (e.g.): During each online writing session, participants logged onto the study website and wrote a journal entry on one of seven commonly used positive affect prompts (e.g., What are you thankful for? What did someone else do for you?; full details available upon request) [60]; all entries were saved on a secure server.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Patients were provided secure access at no cost and could enter from any standard web portal or browser. Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes; extensive theoretical background is provided on how the intervention was developed. Additionally, as noted earlier, the intervention itself (i.e., web portal, prompts, etc.) were xed (not dynamic) but provided "self-guided" content that would result in ideographic and dynamic engagement by the users.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Participants in the PAJ intervention condition were asked to complete online writing sessions for 15 minutes on three days each week for the duration of the 12-week study.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-x) Clarify the level of human involvement Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: indicated that screening, intake, informed consent were in person. All other aspects were conducted online.

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
subitem not at all important 1 2 3 4 5 essential 6a) Completely de ned pre-speci ed primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No reminders were utilized.

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No co-interventions provided.
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Yes: Adherence generally describes the extent to which individuals are exposed to the content of the intervention. For the current study, participants were asked to complete online PAJ sessions an average of three 15-minute sessions per week, over 12 weeks, for a total of 36 journaling sessions throughout the course of the study. Overall PAJ adherence rate was calculated using two methods: 1) weekly journaling counts for each participant-derived from online user login countswere recoded into a binary variable (i.e., yes, no) based on journaling > 1 times per week. The journaling counts for all weeks were then summed, divided by 12, and multiplied by 100 to calculate the overall 12-week adherence rate; 2) total journaling counts for all participants were summed for all weeks of the study, divided by 36, and multiplied by 100.
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text No qualitative data was collected during this stage of work.
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No changes to trial outcomes. Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The sample size was calculated based on an anticipated baseline mean of 11.0 (SD=3) on the HADS-A. This anticipated value was derived from a study of 273 medical patients participating in a web-based education program. Using G*Power, we assumed treatment condition standard deviations similar to those reported by Yun and colleagues [68] and a 5% type I error rate for a two-sided hypothesis test, concluding that 31 subjects per group would provide 80% power to detect a difference in the HADS-A at 3 months (10.0 v. 8.0). This effect size is based on a clinical trial of CBT for distressed medical patients, wherein the CBT arm decreased their HADS-A score by 3.1 points more than controls (7), and a web-based CBT intervention by Farrer and colleagues [21], that observed a 44% reduction in depression scores over 6 months. The current study estimated a reduction of 2.0 in the HADS-A measure (an 18% reduction). Anticipating a dropout rate of <10%, we planned to recruit 70 subjects at baseline. 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No interim analyses conducted; stopping rules were not deemed necessary in this low-risk context.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Computer generated random allocation sequence.
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study For this stage of work we used simple 1:1 assignment; no blocking or strati cation was implemented. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study During the baseline visit, all participants completed baseline surveys and were randomized (via computer generated sequences provided in sealed envelopes) to one of the two conditions. Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Computer generated allocation sequence; assignments provided in sealed envelopes.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A: no assessments or intervention elements conducted by study staff. All assessment and intervention was online.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes: We implemented a treatment as usual wait-list condition for the comparator; thus, patients would know what assignment they have received. Intervention was provided to control patients at trial conclusion to reduce risk of demoralization.
As there is no clinical standard of care treatment for medical patients with mild to moderate anxiety symptoms, participants randomized to the control group received their usual care for the duration of the study. After they had completed all study procedures, participants in the control condition were given access to the PAJ intervention.
Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed All analyses were carried out using SAS Software version 9.4 (SAS Institute, Cary, NC). First, descriptive statistics were calculated for all variables at baseline and each of the three follow-up assessments, and response rates were calculated using the online user login tracking logs. Categorical variables were summarized with frequencies and percentages, and continuous variables were summarized with means, standard deviations, medians, and quartiles. The distribution of continuous variables was checked using box plots, histograms, and normal probability plots. For demographic variables and other characteristics measured at baseline, comparison tests were conducted between the intervention and control groups using a two-sample t-test or Wilcoxon Rank Sum test with means for continuous variables and using a Chi-square test with percentages for categorical variables. A Fisher's Exact test was used as needed when cell counts were too small for the Chi-square test to be valid.
Second, in making comparisons of the differences from baseline to each of the 3 months within and between groups, we used two approaches depending on the type of outcome variable. For continuous outcome variables, we rst found the change from baseline at each subsequent month. A linear mixed effects model was then employed that included factors for group (intervention versus control), month, the interaction between the intervention group and month, and the baseline measurement for adjustment, and the differences between groups were quanti ed with means. For binary outcome variables, a Generalized Estimating Equations model was utilized that included factors for group, month, and the interaction between the group and month, and differences between groups were quanti ed with percentages and odds ratios. All comparisons were adjusted for age, sex, income, and preexisting journaling-re ecting self-reported frequency (i.e., "Never," "Less than once per month," "1-3 times per month," and "At least once per week") of writing in a diary or journal in the year leading up to the study -by including these factors as additional covariates in the models.
subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Missing data was not a signi cant problem for the primary outcome variable (at less than 5%) or for the secondary outcome variables (at less than 10% at most) and was not an issue for any independent variables.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

RESULTS
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study All study procedures were approved by The Pennsylvania State Hershey Medical Center's (PSHMC) Institutional Review Board and all participants provided written informed consent prior to engaging in any research related activity.
Eligible participants met with research staff during a scheduled baseline visit to discuss study procedures and provide written informed consent.

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study All investigators have completed extensive research ethics and safety training; several are practicing physicians who also meet all professional requirements. There were also safety procedures to monitor for signs of risk (e.g., depression/suicidality) and a formalized action plan to respond to such.
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study A total of 99 people were assessed for eligibility of which 88 patients were interested in participating. After further screening, 70 people were eligible, consented, and randomized to the intervention (n=35) or usual care (n=35) condition (Fig 1).
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Three participants were lost to follow-up during the 12-week assessment period and all participants were included in analyses.
subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up 13b-i) Attrition diagram Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement.
Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Figure 1.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study None Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not stopped early subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study All participants used; any missing data is described and explained.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con dence interval) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study ITT analysis provided.
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Patient-user feedback was collected and reported. e.g.: ...participants generally enjoyed the intervention (i.e., 39.4% reported that the journaling activity made them feel "somewhat better" and 18.2% reported that it made them feel "much better"). A total of 67 out of 70 consented and randomized participants competed the study for an overall excellent completion rate of 95%; ...

22-i)
Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes (e.g.): The primary aim of the current study was to examine whether a 12-week online PAJ intervention could reduce mental distress, and improve psychological, Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We note directions for future research, including optimizations for this intervention as well as how this and related approaches can be used for research. Additionally, we highlight challenges and new questions, such as those related to engagement and integration into standard of medical care.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, we discuss the many limitations of this early trial. Most notably, our use of a wait-list control does not fully control for non-speci c factors.

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Yes, we discuss these issues and note that we recruited a diverse sample of general medical patients with varied demographic and clinical characteristicsthus likely enhancing generalizability.

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We approached this trial with an 'effectiveness' perspective; thus it was prepared to be easily implemented in routine clinical/medical setting.
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study was registered on ClinicalTrials.gov (reference number NCT01873599).
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study N/A 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Con icts of Interest (not a CONSORT item) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Funding for this work was provided by the Penn State Social Science Research Institute (SSRI). The funders have no role in the study design, data collection and analysis, decision to publish, or manuscript preparation.
X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Authors developed the intervention for research/clinical use. yes no Other: STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document Any other comments or questions on CONSORT EHEALTH Useful checklist; some redundancies between sections that could be cleaned up. SUBMIT