Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)

Smoking Cessation Clinical Trial

Official title:

An Online Pilot Study of Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951766
• Other study ID #: 2018P002699
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: June 8, 2020

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this pilot study is to solicit feedback from nondaily smokers looking for smoking cessation support online (n=90) about Version 2 of a smartphone app investigators designed to support smoking cessation, and to test if within-person theorized mechanisms of change are occurring as participants undergo the app-assisted quit attempt. Data sources will be passively collected smartphone app usage data, surveys and, in a sub-sample (n=20), online video-conference user feedback sessions. Results will be used to guide the design of Version 3.0 of the "Smiling Instead of Smoking" (SiS) smartphone app. Specifically, the aims of this study are to:

1. Assess ease-of-use and helpfulness of the app, as rated by app users 6 weeks after their chosen smoking cessation date

2. Test if within-person changes occur in theorized mechanisms of behavior change as nondaily smokers undergo a SiS app assisted quit attempt

3. Identify app features in need of improvement, as identified by passively recorded app usage patterns, REDCap open-ended survey items, and, in a sub-sample, user feedback sessions (n=20)

Description:

An estimated 90 participants will participate in this study based on the following eligibility criteria: (a) 18+ years of age, (b) smartphone ownership (c) current nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days (i.e., 71% of nondaily smokers), and (d) has current quit intention (i.e., 65-74% of nondaily smokers). Investigators will stop enrollment when n=90 participants have completed the primary endpoint of the study, which is the 6-week follow-up. This study will be conducted entirely remotely and will require a screening process prior to enrolling participants on the app.

Study participation will last 6 months, where surveys will be administered prior to the quit day (online, as part of a screening test), and at 2-week, 6-week, 3-month, and 6-month follow-ups of the participant's chosen quit day. Participants will use the app for a strongly encouraged period of 7 weeks (1 week before, 6 weeks following the quit attempt), and optional continued use thereafter.

Participants will complete two types of assessment: (1) surveys, and (2) (in a sub-sample) user feedback sessions conducted via phone and/or video-conference call. Potential participants will click-through to the study website. This website will explain that participants must call study staff in order to be phone-screened and to participate in the study. During the phone-screen, participants will be directed to complete an online survey via REDCap. If participants complete the survey and pass the screening test (e.g., correctly responding to reading-check items in the online survey), they choose a smoking cessation quit day, and schedule a phone call with study staff to enroll in the study. This enrollment phone call occurs 1 week prior to the chosen quit day. During this call, study staff will provide the link to download the app, and provide participants with an app-walkthrough. Thereafter, participants will receive survey links for 2-week, 6-week, 3-month and 6-month follow-ups via an emailed link.

Participation in the user feedback session is optional. Within the baseline survey, participants will be asked if they would be willing to participate in an online video-conference user feedback session after they have used the app for seven weeks (1 week pre, 6 weeks post their chosen smoking quit day). If selected for the online user feedback sessions (selected at random from interested participants, with stratification based on gender, age, and race/ethnicity), participants will receive an email and/or phone call upon completing their 6-week survey to set up the user feedback session.

The online user feedback sessions (n=20) will consist of the participants, and 1-2 members of the study staff. Relatively little guidance will be provided in this setting. Instead, 4 open-ended questions will be posed (i.e., did the app help you in your quit attempt? What did you like? What did you dislike? How could the app be improved?). All conference calls will be recorded for later analysis.

Sample size and Power Considerations: The primary goal of this study is to gather qualitative input rather than data to detect a pre-specified effect. The goal of this pilot study is to get input from app users who are interacting with the app and study staff completely remotely, without the benefit of in-person interaction, which is closer to the real-world experience potential users would have than the participants in Study 1.

Planned Analyses:

Aim 1 (Ease-of-use and usefulness). To assess the degree to which SiS Version 2 is easy to use and perceived as useful by nondaily smokers attempting to quit smoking, investigators will use the Week 6 survey data, and will calculate means and standard deviations for the survey items querying ease of use and usefulness for each feature of the app.

Aim 2 (Within-person changes). To test if nondaily smokers utilizing SiS Version 2 experienced changes over time on constructs theorized to underlie smoking cessation, investigators will use the online survey data and fit one repeated measures mixed effects model per construct of interest (i.e., desire to smoke, mood, self-efficacy to quit/stay quit, motivation, outcome expectancies such as pros/cons, stress, coping), where the construct will be the dependent variable, and time (0=baseline, 1=2-week, 2=6-week, 3=3-month, 4=6-month) will be the predictor. Correlations over time will be modeled with an unstructured covariance matrix. The primary endpoint is 6 weeks post quit (i.e., end of treatment). A contrast statement will be used to compare baseline versus 6-week follow-up. Given the explorative nature of this study, investigators will not correct for multiple testing.

Aim 3 (Identify app features in need of improvement). To identify features of the app that are in need of improvement, investigators will examine the passively generated app usage data generated by study participants as they undergo their quit attempts, and will generate descriptive summary statistics on these usage data. To gain deeper insight, investigators will also conduct user feedback sessions with a randomly selected subsample of participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Owns a smartphone

• Is a nondaily smoker, who smokes at least weekly and no more than 25 out of the past 30 days

• Has a current intention to quit smoking

• Interested in using a smartphone app to quit smoking

Exclusion Criteria:

• Under 18 years of age

• Does not own a smartphone

• Is not a nondaily smoker, who smokes at least weekly and no more than 25 out of the past 30 days

• Does not have a current intention to quit smoking

• Is not interested in using a smartphone app to quit smoking

Related Conditions & MeSH terms

• Smoking Cessation
• Smoking, Tobacco

Intervention

Behavioral:
• Smiling Instead of Smoking (SiS) App Version 2
The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

Asher MK, Martin RA, Rohsenow DJ, MacKinnon SV, Traficante R, Monti PM. Perceived barriers to quitting smoking among alcohol dependent patients in treatment. J Subst Abuse Treat. 2003 Mar;24(2):169-74. — View Citation

Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. — View Citation

Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. — View Citation

Etter JF, Humair JP, Bergman MM, Perneger TV. Development and validation of the Attitudes Towards Smoking Scale (ATS-18). Addiction. 2000 Apr;95(4):613-25. — View Citation

Kahler CW, Lachance HR, Strong DR, Ramsey SE, Monti PM, Brown RA. The commitment to quitting smoking scale: initial validation in a smoking cessation trial for heavy social drinkers. Addict Behav. 2007 Oct;32(10):2420-4. Epub 2007 Apr 6. — View Citation

Lyubomirsky, S., & Lepper, H. (1999). A measure of subjective happiness: Preliminary reliability and construct validation. Social Indicators Research, 46, 137-155.

Ward RM, Velicer WF, Rossi JS, Fava JL, Prochaska JO. Factorial invariance and internal consistency for the decisional balance inventory--short form. Addict Behav. 2004 Jul;29(5):953-8. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Features of App That Need Improvement - App Usage	App usage, as quantified by the number of days of used during the prescribed period of app use (i.e., 49), based on passively recorded app usage patterns.	6 weeks after chosen smoking cessation date
Other	Self-reported Smoking Status	Participants were asked "Have you been abstinent during the past 30 days?" in follow-up to providing their current smoking status as "I do not smoke at all." The outcome is presented as a % of participants who self-reported 30-day point-prevalence smoking abstinence. Participants were assumed to be smoking if they did not complete surveys.	Baseline, 2 weeks post-quit, 6 weeks post-quit, 3-months post-quit, 6-months post-quit
Primary	Ease-of-use and Helpfulness of the App	As rated by app users 6 weeks after their chosen smoking cessation date via open-ended REDCap survey. This survey asks questions concerning feasibility, usefulness, and overall opinions of specific app features. Responses were rated on 4-point Likert-scales with ease-of-use rated with the options 0 = Not easy at all | 1 = Somewhat easy to use | 2 = Easy to use | 3 = Very easy to use, and usefulness rated with the options 0 = Not at all useful | 1 = Somewhat useful | 2 = Useful | 3 = Very useful. For both ease-of-use and usefulness items, scores range from 0 to 3 with higher scores indicating a better opinion of the app features.	6 weeks after chosen smoking cessation date
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)	This 10-item scale assesses overall nicotine dependence, craving, and smoking withdrawal symptoms. Items were rated on a 7-point Likert-scale ranging from 1=Strongly disagree to 7=Strongly agree. We presented mean instead of total scores for ease in interpretation, so that scale scores can range from 1.0 to 7.0, with higher scores indicating greater smoking urges.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges Measure	Single-item measure: "Right now, how strong is your desire/urge to smoke?". This single-item measure was rated on a scale of "0, not at all strong" to "100, extremely strong", so that higher scores indicate stronger smoking urges.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)	This 20-item scale measures positive and negative. Participants were asked to indicate how they felt in the past week, using a 5-point Likert scale ranging from 1="very slightly or not at all" to 5="extremely." Scores for 10 positive words and 10 negative words were summed separately and were reported as mean scores (not scale totals) ranging from 1-5, with lower scores indicating low (positive or negative) affect and higher scores indicating high (positive or negative) affect. The 10 items for POSITIVE (PA) affect are attentive, interested, alert, excited, enthusiastic, inspired, proud, determined, strong, and active. The 10 items for NEGATIVE (NA) affect are distressed, upset, hostile, irritable, scared, afraid, ashamed, guilty, nervous, and jittery.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)	This 4-item scale assesses global subjective happiness. Each question is rated on a Likert-scale of 1-7. Scale scores were reported as mean scores in this study, with higher scores indicating higher subjective happiness.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness Measures	Two single-item happiness measures were used: "In the PAST WEEK, how happy have you felt?" and "How happy are you feeling RIGHT NOW?". Both items were rated on slider scales ranging from 0="not at all" to 100="extremely", such that higher scores indicate greater levels of happiness.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)	The 12-item Smoking Self-Efficacy Questionnaire (SEQ-12) assesses confidence to abstain from smoking when faced with internal stimuli (6 items; e.g., when I feel very anxious) and external stimuli (6 items; e.g., after a meal). Items were assessed on slider scales ranging from 0="not at all confident" to 100="extremely confident" and results are presented as mean scale scores, where higher scores indicate greater self-efficacy to abstain from smoking.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy Measure	The single-item self-efficacy measure asked: "How CONFIDENT are you that you will be able to quit smoking/stay quit?" This item was measured on a slider scale ranging from 0="not at all" to 100="extremely confident", so that higher scores indicate greater confidence in the ability to quit smoking or stay quit.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit Measure	The single-item self-efficacy measure asked: "How MOTIVATED are you to quit smoking/ stay quit?" This item was measured on a slider scale ranging from 0="not at all" to 100="extremely motivated", where higher scores indicate a greater motivation to quit smoking or stay quit.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)	The 18-item Attitudes Towards Smoking (ATS-18) scale measures attitudes towards smoking in current and former cigarette smokers. It was rated on a 5-point Likert scale, from 1="strongly disagree" to 5="strongly agree.". The ATS-18 has 3 sub-scales: Adverse effects of smoking (items 1-10), psychoactive benefits of smoking (items 11-14), and pleasure of smoking (items 15-18). To score, all items per sub-scale were averaged to obtain a mean score within each sub-scale. For each sub-scale, higher scores indicate greater agreement with the specific attitude towards smoking.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)	The Commitment to Quitting Smoking Scale (CQSS) asks participants to rate their level of agreement (Likert scale, 1="strongly disagree" to 5="strongly agree") on 8-items assessing motivation to quit smoking (e.g., I'm not going to let anything get in the way of my quitting smoking).; Scale scores are reported as the average of all items, where higher scores indicate a greater commitment to quitting smoking.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)	This 6-item form assesses the personal importance people place on positive and negative smoking expectancies. Items were rated on slider scales ranging from 0="not at all important" to 100="extremely important." Two sub-scale mean scores were calculated: positive expectancies (3 items), and negative smoking expectancies (3 items). On both scales, higher scores indicate a greater importance of the smoking expectancies (positive or negative).	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking Measures	Two single-item measures assessed the pros and cons of being smoke-free: (1) "Think about all the things you LIKE/LOVE about quitting/being smoke-free; taken together, how important are those things to you RIGHT NOW?" and (2) "Think about all the things you DISLIKE/HATE about quitting/being smoke-free; taken together, how important are those things to you RIGHT NOW?" Both single-item measures were rated on slider scales ranging from 0="not at all" to 100="extremely important", so that higher scores indicate a greater perceived importance of the pros and cons of being smoke-free, respectively.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)	This 10-item scale assesses perceived stress during the past month. Items were rated on a 5-point Likert scale ranging from 0="Never" to 4="Very Often." The overall scale score is the total of all 10 items, of which 4 are reverse-coded, so that score totals can range from 0 to 40 with higher scores indicating greater levels of perceived stress. The PSS has two sub-scales that assess perceived helplessness (6 items) and perceived self-efficacy (4 items). Sub-scale scores were calculated as mean scores of all sub-scale items (sub-scale score ranges: 0-4), so that higher scores on the sub-scales indicate higher perceived helplessness or higher perceived self-efficacy, respectively.	Baseline, 2-weeks, and 6-weeks post-quit
Secondary	Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)	This 28-item scale assesses the use of 14 coping mechanisms. Each item was rated on a 4-point Likert-scale, where 1="I haven't been doing this at all", 2="I've been doing this a little bit", 3="I've been doing this a medium amount", and 4="I've been doing this a lot." Sub-scales consist of 2 items for each of 14 coping mechanisms with no reversals of coding: (1) Self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, (14) self-blame. Sub-scale scores range from 2 to 8 with higher scores indicating more frequent use of each specific coping mechanism, regardless of whether they are considered adaptive or maladaptive.	Baseline, 2-weeks, and 6-weeks post-quit