A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial

Background Smartphone apps for smoking cessation could offer easily accessible, highly tailored, intensive interventions at a fraction of the cost of traditional counseling. Although there are hundreds of publicly available smoking cessation apps, few have been empirically evaluated using a randomized controlled trial (RCT) design. The Smart-Treatment (Smart-T2) app is a just-in-time adaptive intervention that uses ecological momentary assessments (EMAs) to assess the risk for imminent smoking lapse and tailors treatment messages based on the risk of lapse and reported symptoms. Objective This 3-armed pilot RCT aimed to determine the feasibility and preliminary efficacy of an automated smartphone-based smoking cessation intervention (Smart-T2) relative to standard in-person smoking cessation clinic care and the National Cancer Institute’s free smoking cessation app, QuitGuide. Methods Adult smokers who attended a clinic-based tobacco cessation program were randomized into groups and followed for 13 weeks (1 week prequitting through 12 weeks postquitting). All study participants received nicotine patches and gum and were asked to complete EMAs five times a day on study-provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages after the completion of each EMA. Both Smart-T2 and QuitGuide apps offer on-demand smoking cessation treatment. Results Of 81 participants, 41 (50%) were women and 55 (68%) were white. On average, participants were aged 49.6 years and smoked 22.4 cigarettes per day at baseline. A total of 17% (14/81) of participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks postquitting (Smart-T2: 6/27, 22%, QuitGuide: 4/27, 15%, and usual care: 4/27, 15%), with no significant differences across groups (P>.05). Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking, and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group. Conclusions Dynamic smartphone apps that tailor intervention content in real time may increase user engagement and exposure to treatment-related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling. Trial Registration ClinicalTrials.gov NCT02930200; https://clinicaltrials.gov/show/NCT02930200

1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
Does your paper address subitem 1a-iii? * "for smoking cessation" 1b-i) Key features/functionalities/components of the intervention an Does your paper address subitem 1b-i? * "Participants in the Smart-T2 group received tailored treatment messages at the completion of each EMA. Both Smart-T2 and QuitGuide apps offered on-demand smoking cessation treatment." You're editing your response. Sharing this URL allows others to also edit your response.

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1b-ii) Level of human involvement in the METHODS section of the A Does your paper address subitem 1b-ii? "All study participants received nicotine patches and gum, and all participants were asked to complete EMAs 5 times a day on study provided smartphones for 5 weeks. Participants in the Smart-T2 group received tailored treatment messages at the completion of each EMA.
Both Smart-T2 and QuitGuide apps offered on-demand smoking 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-fa You're editing your response. Sharing this URL allows others to also edit your response.

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Does your paper address subitem 1b-iii? "Adults smokers who attended a clinic-based tobacco cessation program " 1b-iv) RESULTS section in abstract must contain use data Does your paper address subitem 1b-iv? "A total of 14 (17.3%) participants were biochemically confirmed 7-day point prevalence abstinent at 12 weeks post-quit (Smart-T2: 22.2%, QuitGuide: 14.8%, Usual Care: 14.8%), with no significant differences across groups. Participants in the Smart-T2 group rated the app positively, with most participants agreeing that they can rely on the app to help them quit smoking and endorsed the belief that the app would help them stay quit, and these responses were not significantly different from the ratings given by participants in the usual care group." You're editing your response. Sharing this URL allows others to also edit your response. Dynamic smartphone apps that tailor intervention content in real-time may increase user engagement and exposure to treatment related materials. The results of this pilot RCT suggest that smartphone-based smoking cessation treatments may be capable of providing similar outcomes to traditional, in-person counseling.
You're editing your response. Sharing this URL allows others to also edit your response. Does your paper address CONSORT subitem 2b? * "The purpose of the current study was to compare, in a pilot randomized controlled trial, the feasibility and preliminary effectiveness of a smartphone-delivered JITAI for smoking cessation (Smart-T2) to the NCI QuitGuide app and usual care in-person tobacco cessation treatment."

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3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * "At baseline, participants were randomized into one of the following treatment groups: 1) Smart-Treatment (Smart-T2) phone-based automated smoking cessation treatment, 2) National Cancer Institute (NCI) QuitGuide app, or 3) usual tobacco cessation clinic care (TTRP)." Does your paper address CONSORT subitem 3b? * N/A -no changes made after trial commencement 3b-i) Bug fixes, Downtimes, Content Changes You're editing your response. Sharing this URL allows others to also edit your response.

4a) Eligibility criteria for participants
Does your paper address subitem 3b-i? N/A -no relevant bug fixes, downtime, or content changes Does your paper address CONSORT subitem 4a? * "Individuals were eligible to participate if they: 1) demonstrated > 6th grade English literacy level, 2) were willing to quit smoking 7 days from their first visit, 3) were ≥ 18 years of age, 4) had an expired carbon monoxide (CO) level > 7 ppm suggestive of current smoking, 5) reported smoking ≥ 5 cigarettes per day, 6) were willing and able to attend 4 inperson assessment sessions, and 7) had no contraindications for over the counter NRT (i.e., uncontrolled blood pressure, myocardial infarction within the past two weeks, or current pregnancy or plans to become 4a-i) Computer / Internet literacy You're editing your response. Sharing this URL allows others to also edit your response.

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Does your paper address subitem 4a-i? Computer literacy was not evaluated but participants were provided with study phones and were trained to use the app, "All participants were provided with a smartphone (Samsung Galaxy On5) at the baseline visit, were trained to use their assigned app by study staff..." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Does your paper address subitem 4a-ii? * "Participants were followed for 13 weeks (1 week pre-quit through 12 weeks post-quit), and completed in-person assessments at the baseline, quit-date (1 week after baseline), and 4 and 12 weeks post-quit visits..." "Participants were prompted to complete EMAs 5 times per day (4 random assessments + 1 daily diary) for five weeks (1 week pre-quit and 4 You're editing your response. Sharing this URL allows others to also edit your response.

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4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Does your paper address subitem 4a-iii? "All participants were provided with a smartphone preloaded with their assigned smoking cessation app and/or the EMA app for 5 weeks.." "were trained to use their assigned app by study staff, and were asked to carry the phone with them at all times." Does your paper address CONSORT subitem 4b? * "Individuals were screened for eligibility following provider or self-referral to the Tobacco Treatment Research Program (TTRP)..." You're editing your response. Sharing this URL allows others to also edit your response.

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4b-i) Report if outcomes were (self-)assessed through online questi Does your paper address subitem 4b-i? * "completed in-person assessments at the baseline, quit-date (1 week after baseline), and 4 and 12 weeks post-quit visits..." "At each in-person visit following the scheduled quit date, participants were asked if they smoked "even a puff" during the past 7 days. Abstinence was verified via expired carbon monoxide (CO) at each visit using a Vitalograph CO 4b-ii) Report how institutional affiliations are displayed Does your paper address subitem 4b-ii?
Participants came from a subsample of individuals who were already referred to a tobacco research clinic affiliated with a university.
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5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponso Does your paper address subitem 5-i? "Programming and technological support was provided through the mHealth Shared Resource of the Stephenson Cancer Center via an NCI Cancer Center Support Grant " 5-ii) Describe the history/development process You're editing your response. Sharing this URL allows others to also edit your response.

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Does your paper address subitem 5-ii?
Addressed in introduction and then in methods "The Smart-T2 app has been described in detail elsewhere..." with citation.

5-iii) Revisions and updating
Does your paper address subitem 5-iii?
Intervention described as 2nd version 5-iv) Quality assurance methods You're editing your response. Sharing this URL allows others to also edit your response.

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Does your paper address subitem 5-iv?
Outcome data collected in person and biochemically verified 5-v) Ensure replicability by publishing the source code, and/or provi Does your paper address subitem 5-v? Screenshot included in text, algorithm described in prior paper and referenced in introduction.

5-vi) Digital preservation webcitation.org
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Does your paper address subitem 5-vi?
This was a pilot study and the intervention is not yet available to the public. A screenshot of the intervention is included in the paper.

5-vii) Access
Does your paper address subitem 5-vii? * "All participants were provided with a smartphone preloaded with their assigned smoking cessation app and/or the EMA app" You're editing your response. Sharing this URL allows others to also edit your response.

5-viii) Mode of delivery, features/functionalities/components of the
Does your paper address subitem 5-viii? * "Smart-T2 is a multi-component adjunctive smoking cessation app featuring: 1) an algorithm that evaluates current risk of smoking lapse based on EMA responses and pushes tailored messages to help participants cope, 2) a "Quit Tips" button offering cessation advice, coping strategies, and quitting benefits, 3) a "Medications" button offering information about smoking cessation medications, 4) a "Phone a Counselor" button that calls the free Oklahoma Tobacco Help Line, 5) daily treatment messages (e.g., your quit date is tomorrow), 6) a button to request additional NRT through the EMA app home screen." You're editing your response. Sharing this URL allows others to also edit your response.

5-ix) Describe use parameters
Does your paper address subitem 5-ix? "Intervention messages were delivered at the completion of every EMA. "

5-x) Clarify the level of human involvement
Does your paper address subitem 5-x? "a "Call Staff" function/button that automatically called study staff when/if participants had problems with the phone" You're editing your response. Sharing this URL allows others to also edit your response.

5-xi) Report any prompts/reminders used
Does your paper address subitem 5-xi? * "Participants were prompted to complete EMAs 5 times per day (4 random assessments + 1 daily diary) for five weeks..." "when EMA responses indicated a high risk of imminent lapse, participants received a message to chew a piece of nicotine gum to reduce their risk for lapse" 5-xii) Describe any co-interventions (incl. training/support) You're editing your response. Sharing this URL allows others to also edit your response.

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6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address subitem 5-xii? * "all participants received a 2 week supply of over the counter NRT (i.e., patches and gum) for the initial post-quit period. Upon request, participants were offered up to 8 additional weeks of nicotine patches and up to 10 additional weeks of nicotine gum." Does your paper address CONSORT subitem 6a? * "At each in-person visit following the scheduled quit date, participants were asked if they smoked "even a puff" during the past 7 days.
Abstinence was verified via expired carbon monoxide (CO) at each visit using a Vitalograph CO monitor. Self-reported abstinence over the specified time period and a CO reading below 8 ppm (10 ppm on the quit date) were required to be considered abstinent"..."At the quit date and 4-week post-quit visits, participants also answered questions to evaluate their satisfaction and therapeutic alliance with their smoking cessation counselor or assigned smoking cessation smartphone application." You're editing your response. Sharing this URL allows others to also edit your response.

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6a-i) Online questionnaires: describe if they were validated for onlin Does your paper address subitem 6a-i? Questionnaires were taken in person (not via web) or were closed system within mobile phone. Majority of CHERRIES items do not apply, but others (such as description of incentives) are presented in methods section.

6a-ii) Describe whether and how "use" (including intensity of use/do
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6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii? "Among the 27 participants in the Smart-T2 group, 14 participants (51.9%) accessed the on-demand medication tips, and 20 participants (74.1%) accessed the on-demand quit tips. Once a participant selected a specific category of message, they could click "next" to view multiple messages within that category. The most frequently selected tip types were "Coping with Others Smoking" and "Harms of Smoking" (selected an average of 2.0 times during the intervention period), followed by the "Coping with Mood" (selected an average of 1.8 times), and the "Medication: Nicotine Gum" (selected an average of 1.5 times)..." "Among the participants in the QuitGuide treatment group, 21 of the 27 participants (77.8%) opened the app an average of 9.9 times (SD=7.4) and interacted with the application for an average of 10.6 days (SD=4.8; range= 2-20 days) during the EMA 6a-iii) Describe whether, how, and when qualitative feedback from p Does your paper address subitem 6a-iii?
Qualitative feedback not obtained.
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7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 6b? * Not applicable -trial outcomes did not change.

7a-i) Describe whether and how expected attrition was taken into ac
Does your paper address subitem 7a-i?
This was a pilot study that was not powered to detect any differences between groups.
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8a) Method used to generate the random allocation sequence 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? * "using a simple computer-generated randomization scheme" Does your paper address CONSORT subitem 10? * "using a simple computer-generated randomization scheme" You're editing your response. Sharing this URL allows others to also edit your response.

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11a-i) Specify who was blinded, and who wasn't Does your paper address subitem 11a-i? * No blinding done.
11a-ii) Discuss e.g., whether participants knew which intervention w Does your paper address subitem 11a-ii? "Participants were informed that the study purpose was to compare 3 smoking cessation treatment approaches and were provided with a detail outline of study procedures, and written informed consent was obtained. " You're editing your response. Sharing this URL allows others to also edit your response.

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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) 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 Does your paper address CONSORT subitem 11b? * "All participants were provided with a smartphone preloaded with their assigned smoking cessation app and/or the EMA app for 5 weeks. In addition, all participants received a 2 week supply of over the counter NRT (i.e., patches and gum) for the initial post-quit period. Upon request, participants were offered up to 8 additional weeks of nicotine patches and up to 10 additional weeks of nicotine gum." Does your paper address CONSORT subitem 12a? * "Descriptive statistics were used to summarize participant demographics and engagement with the smartphone app. Comparisons between groups were made with Chi-square tests or ANOVA with Fisher's Least Significant Difference post-hoc test, as appropriate. All analyses were conducted in IBM SPSS version 26." You're editing your response. Sharing this URL allows others to also edit your response.

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12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item) 12a-i) Imputation techniques to deal with attrition / missing values Does your paper address subitem 12a-i? * Imputation not used. "Participants who did not provide biochemical confirmation of abstinence (e.g., they did not attend the visit) were considered smoking." Does your paper address CONSORT subitem 12b? * Not applicable.
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X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i? "The study procedure was approved by the Institutional Review Board at the University of Oklahoma Health Sciences Center." x26-ii) Outline informed consent procedures Does your paper address subitem X26-ii?
Participants were informed that the study purpose was to compare 3 smoking cessation treatment approaches and were provided with a detail outline of study procedures, and written informed consent was obtained.
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RESULTS
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 X26-iii) Safety and security procedures Does your paper address subitem X26-iii? "All data collected through the smartphone app were de-identified and encrypted. " Does your paper address CONSORT subitem 13a? * "Ninety-eight individuals were assessed for eligibility. Of those, 84 were eligible and consented to participate in the study. Three individuals dropped out of the study before the baseline visit was completed, thus all analyses include the remaining 81 participants" You're editing your response. Sharing this URL allows others to also edit your response. You're editing your response. Sharing this URL allows others to also edit your response.

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14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * "Data collection took place between May 2017 and October 2018.
Participants were followed for 13 weeks (1 week pre-quit through 12 weeks post-quit), and completed in-person assessments at the baseline, quit-date (1 week after baseline), and 4 and 12 weeks post-quit visits. " 14a-i) Indicate if critical "secular events" fell into the study period Does your paper address subitem 14a-i? Not applicable.
Does your paper address CONSORT subitem 14b? * Not applicable.
You're editing your response. Sharing this URL allows others to also edit your response. A table showing baseline demographic and clinical  characteristics for each group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Table 1 includes demographic characterisitcs.

15-i) Report demographics associated with digital divide issues
Does your paper address subitem 15-i? * Demographics included in table 1, smartphones were provided so other potential access issues were not applicable.
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16-i) Report multiple "denominators" and provide definitions
Does your paper address subitem 16-i? * N's reported in all tables.

16-ii) Primary analysis should be intent-to-treat
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17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Pilot study so primary outcomes were related to feasibility and app perceptions, but smoking outcomes were intent to treat. "A total of 37 (45.7%) participants were confirmed abstinent (7-day point prevalence, intent to treat) at 4 weeks post-quit (Smart-T2: 22.2%, QuitGuide: 25.9%, Usual Care: 25.9%), and 14 (17.3%) participants were confirmed abstinent at 12 weeks post-quit (Smart-T2: 22.2%, QuitGuide: 14.8%, Usual Care: Does your paper address CONSORT subitem 17a? * Study not powered to estimate meaningful effect sizes. 17a-i) Presentation of process outcomes such as metrics of use and You're editing your response. Sharing this URL allows others to also edit your response.

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17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address subitem 17a-i? Multiple examples throughout results -"Among the 27 participants in the Smart-T2 group, 14 participants (51.9%) accessed the on-demand medication tips, and 20 participants (74.1%) accessed the on-demand quit tips. Once a participant selected a specific category of message, they could click "next" to view multiple messages within that category. The most frequently selected tip types were "Coping with Others Smoking" and "Harms of Smoking" (selected an average of 2.0 times during the intervention period), followed by the "Coping with Mood" (selected an average of 1.8 times), and the "Medication: Nicotine Gum" (selected an Does your paper address CONSORT subitem 17b? * Not applicable -study not powered.
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