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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03951766
Enrollment
100
Registered
2019-05-15
Start date
2019-06-24
Completion date
2020-06-08
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Smoking, Tobacco

Keywords

mHealth, smartphone, smoking cessation, app, happiness, positive psychology, nondaily smoking

Brief 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)

Detailed 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.

Interventions

BEHAVIORALSmiling 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.

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pilot study: all participants will use the smartphone app for a total of 7 weeks.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ease-of-use and Helpfulness of the App6 weeks after chosen smoking cessation dateAs 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.

Secondary

MeasureTime frameDescription
Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)Baseline, 2-weeks, and 6-weeks post-quitThis 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges MeasureBaseline, 2-weeks, and 6-weeks post-quitSingle-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.
Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)Baseline, 2-weeks, and 6-weeks post-quitThis 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy MeasureBaseline, 2-weeks, and 6-weeks post-quitThe 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)Baseline, 2-weeks, and 6-weeks post-quitThis 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresBaseline, 2-weeks, and 6-weeks post-quitTwo 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)Baseline, 2-weeks, and 6-weeks post-quitThe 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)Baseline, 2-weeks, and 6-weeks post-quitThis 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Baseline, 2-weeks, and 6-weeks post-quitThis 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit MeasureBaseline, 2-weeks, and 6-weeks post-quitThe 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)Baseline, 2-weeks, and 6-weeks post-quitThe 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)Baseline, 2-weeks, and 6-weeks post-quitThe 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.
Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)Baseline, 2-weeks, and 6-weeks post-quitThis 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).
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking MeasuresBaseline, 2-weeks, and 6-weeks post-quitTwo 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.

Other

MeasureTime frameDescription
Features of App That Need Improvement - App Usage6 weeks after chosen smoking cessation dateApp 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.
Self-reported Smoking StatusBaseline, 2 weeks post-quit, 6 weeks post-quit, 3-months post-quit, 6-months post-quitParticipants 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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited between 06/24/2019 and 11/15/2019. Study recruitment information was displayed on Craigslist, Facebook, Reddit, Smokefree.gov, ClinicalTrials.gov, a study recruitment website at Massachusetts General Hospital, our study website, and websites of local universities. Recruitment was bolstered through word of mouth referrals.

Pre-assignment details

All participants who were enrolled were assigned to the single treatment arm.

Participants by arm

ArmCount
Smiling Instead of Smoking (SiS) App Version 2
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.
100
Total100

Withdrawals & dropouts

PeriodReasonFG000
Follow-up PhaseLost to Follow-up10
Treatment PhaseLost to Follow-up1

Baseline characteristics

CharacteristicSmiling Instead of Smoking (SiS) App Version 2
Age, Continuous35.9 years
STANDARD_DEVIATION 11.4
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
88 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Ever quit before77 Participants
Ever smoked daily70 Participants
Number of cigarettes smoked per smoking day4.6 number of cigarettes per day
STANDARD_DEVIATION 3.3
Number of days smoked in past 30 days14.7 days
STANDARD_DEVIATION 4.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
10 Participants
Race (NIH/OMB)
Black or African American
14 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
75 Participants
Region of Enrollment
United States
100 participants
Sex/Gender, Customized
Self-reported gender identity
Female
61 Participants
Sex/Gender, Customized
Self-reported gender identity
Male
39 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 100
other
Total, other adverse events
0 / 100
serious
Total, serious adverse events
0 / 100

Outcome results

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.

Time frame: 6 weeks after chosen smoking cessation date

Population: Of the 99 people still active in the trial at the end-of-treatment visit, 4 had missing data for all ease-of-use and helpfulness ratings, and 1-2 people had missing ratings for some but not all items on this questionnaire.

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Completing the positive psychology exercises every day.2.39 units on a scaleStandard Deviation 0.89
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Specifically, completing the specific exercise called 3 Good Things.2.36 units on a scaleStandard Deviation 0.89
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Specifically, completing the specific exercise called Savoring.2.42 units on a scaleStandard Deviation 0.79
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Specifically, completing the specific exercise called Experiencing Kindness.2.39 units on a scaleStandard Deviation 0.9
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Specifically, completing the specific exercise called Rose, Thorn and Bud.2.40 units on a scaleStandard Deviation 0.83
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Viewing your past happiness exercises in the Happiness Log.2.64 units on a scaleStandard Deviation 0.67
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Viewing Owl Wisdoms within the Treasure Chest menu.2.57 units on a scaleStandard Deviation 0.65
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Setting and re-setting your quit day.2.51 units on a scaleStandard Deviation 0.77
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Completing the behavioral challenges.2.52 units on a scaleStandard Deviation 0.73
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Accessing and updating your cigarette log.2.61 units on a scaleStandard Deviation 0.75
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Accessing the I have a craving feature (Magma Bear game).2.32 units on a scaleStandard Deviation 0.94
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Adding and viewing your personal reasons for quitting within the Action Plan menu.2.47 units on a scaleStandard Deviation 0.78
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Viewing strategies for remaining smoke-free within the Action Plan menu.2.55 units on a scaleStandard Deviation 0.68
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Viewing your earned badges within the Treasure Chest menu.2.65 units on a scaleStandard Deviation 0.56
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Viewing benefits of quitting within the Treasure Chest menu.2.58 units on a scaleStandard Deviation 0.61
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Completing the positive psychology exercises every day.2.19 units on a scaleStandard Deviation 0.9
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Specifically, completing the specific exercise called 3 Good Things.2.23 units on a scaleStandard Deviation 0.92
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Specifically, completing the specific exercise called Savoring.2.16 units on a scaleStandard Deviation 0.95
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Specifically, completing the specific exercise called Experiencing Kindness.2.13 units on a scaleStandard Deviation 0.98
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Specifically, completing the specific exercise called Rose, Thorn and Bud.2.09 units on a scaleStandard Deviation 0.96
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Viewing your past happiness exercises within the Happiness Log.2.16 units on a scaleStandard Deviation 0.9
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Completing the behavioral challenges.2.21 units on a scaleStandard Deviation 0.9
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Specifically, completing the specific exercise called Reliving Happy Moments.2.54 units on a scaleStandard Deviation 0.77
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppEase of use: Adding and being reminded of your smoke alarms within the Action Plan menu.2.37 units on a scaleStandard Deviation 0.84
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Specifically, completing the specific exercise called Reliving Happy Moments.2.22 units on a scaleStandard Deviation 0.92
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: . Viewing Owl Wisdoms within the Treasure Chest menu.2.19 units on a scaleStandard Deviation 0.91
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Setting and re-setting your quit day.2.07 units on a scaleStandard Deviation 0.98
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Accessing and updating your cigarette log.2.39 units on a scaleStandard Deviation 0.82
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Using the I have a craving feature (Magma Bear game).1.32 units on a scaleStandard Deviation 1.24
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Adding and being reminded of your smoke alarms within the Action Plan menu.2.08 units on a scaleStandard Deviation 0.96
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Adding and viewing your personal reasons for quitting within the Action Plan menu.2.34 units on a scaleStandard Deviation 0.82
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Viewing strategies for remaining smoke-free within the Action Plan menu.2.29 units on a scaleStandard Deviation 0.86
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Viewing your earned badges within the Treasure Chest menu.2.01 units on a scaleStandard Deviation 1.03
Smiling Instead of Smoking (SiS) App Version 2Ease-of-use and Helpfulness of the AppUsefulness: Viewing benefits of quitting within the Treasure Chest menu.2.21 units on a scaleStandard Deviation 0.89
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data, n=4 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Adverse effects of smoking - Baseline4.42 units on a scaleStandard Deviation 0.54
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Adverse effects of smoking - Week 24.46 units on a scaleStandard Deviation 0.55
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Adverse effects of smoking - Week 64.44 units on a scaleStandard Deviation 0.83
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Psychoactive benefits of smoking - Baseline3.97 units on a scaleStandard Deviation 0.73
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Psychoactive benefits of smoking - Week 23.59 units on a scaleStandard Deviation 1.01
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Psychoactive benefits of smoking - Week 63.17 units on a scaleStandard Deviation 1.29
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Pleasure of smoking - Baseline3.27 units on a scaleStandard Deviation 1
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Pleasure of smoking - Week 22.95 units on a scaleStandard Deviation 1.23
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)ATS-18 Pleasure of smoking - Week 62.67 units on a scaleStandard Deviation 1.29
Comparison: ATS - Adverse Effectsp-value: 0.7695% CI: [-0.1, 0.2]t-test, 2 sided
Comparison: ATS - Psychoactive Benefitsp-value: <0.000195% CI: [-1, -0.5]t-test, 2 sided
Comparison: ATS - Pleasurep-value: <0.000195% CI: [-0.8, -0.3]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data for Brief COPE - Acceptance and Brief COPE denial - Baseline, n=4 were missing Week 2 data (with n=5 incomplete for Brief COPE use of emotional support, Brief COPE use of instrumental support, Brief COPE planning, Brief COPE self-blame), n=5 has incomplete baseline date (with n=6 incomplete for Brief COPE religion, Brief COPE active coping, Brief COPE Self-distraction).

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE active coping - Week 66.36 score on a scaleStandard Deviation 1.61
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE use of instrumental support - Week 25.44 score on a scaleStandard Deviation 1.88
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE behavioral disengagement - Week 63.52 score on a scaleStandard Deviation 1.79
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE positive reframing - Week 65.87 score on a scaleStandard Deviation 1.85
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE planning - Baseline6.55 score on a scaleStandard Deviation 1.4
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE planning - Week 65.95 score on a scaleStandard Deviation 1.76
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE humor - Baseline4.48 score on a scaleStandard Deviation 2
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE humor - Week 24.35 score on a scaleStandard Deviation 2.12
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE self-blame - Week 24.09 score on a scaleStandard Deviation 1.86
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE Self-distraction - Baseline5.91 score on a scaleStandard Deviation 1.52
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE Self-distraction - Week 26.46 score on a scaleStandard Deviation 1.61
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE Self-distraction - Week 66.28 score on a scaleStandard Deviation 1.69
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE active coping - Baseline6.57 score on a scaleStandard Deviation 1.22
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE active coping - Week 26.46 score on a scaleStandard Deviation 1.44
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE denial - Baseline3.33 score on a scaleStandard Deviation 1.77
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE denial - Week 23.48 score on a scaleStandard Deviation 1.82
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE denial - Week 63.33 score on a scaleStandard Deviation 1.81
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE substance use - Baseline3.21 score on a scaleStandard Deviation 1.91
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE substance use - Week 23.16 score on a scaleStandard Deviation 1.88
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE substance use - Week 63.12 score on a scaleStandard Deviation 1.86
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE use of emotional support - Baseline5.12 score on a scaleStandard Deviation 1.85
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE use of emotional support - Week 25.68 score on a scaleStandard Deviation 1.93
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE use of emotional support - Week 65.40 score on a scaleStandard Deviation 2.02
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE use of instrumental support - Baseline5.35 score on a scaleStandard Deviation 1.98
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE use of instrumental support - Week 65.46 score on a scaleStandard Deviation 1.93
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE behavioral disengagement - Baseline3.26 score on a scaleStandard Deviation 1.42
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE behavioral disengagement - Week 23.28 score on a scaleStandard Deviation 1.71
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE venting - Baseline5.13 score on a scaleStandard Deviation 1.67
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE venting - Week 24.96 score on a scaleStandard Deviation 1.84
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE venting - Week 64.60 score on a scaleStandard Deviation 1.85
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE positive reframing - Baseline6.10 score on a scaleStandard Deviation 1.62
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE positive reframing - Week 26.22 score on a scaleStandard Deviation 1.62
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE planning - Week 26.12 score on a scaleStandard Deviation 1.76
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE humor - Week 64.42 score on a scaleStandard Deviation 2.09
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE acceptance - Baseline5.76 score on a scaleStandard Deviation 1.48
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE acceptance - Week 26.23 score on a scaleStandard Deviation 1.52
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE acceptance - Week 66.20 score on a scaleStandard Deviation 1.69
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE religion - Baseline4.37 score on a scaleStandard Deviation 2.14
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE religion - Week 24.51 score on a scaleStandard Deviation 2.29
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE religion - Week 64.56 score on a scaleStandard Deviation 2.31
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE self-blame - Baseline4.79 score on a scaleStandard Deviation 2.07
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)Brief COPE self-blame - Week 63.99 score on a scaleStandard Deviation 2.13
p-value: 0.08795% CI: [-0.1, 0.8]t-test, 2 sided
p-value: 0.286695% CI: [-0.6, 0.2]t-test, 2 sided
p-value: 0.929695% CI: [-0.4, 0.4]t-test, 2 sided
p-value: 0.659995% CI: [-0.5, 0.3]t-test, 2 sided
p-value: 0.231595% CI: [-0.2, 0.7]t-test, 2 sided
p-value: 0.618395% CI: [-0.3, 0.6]t-test, 2 sided
p-value: 0.203795% CI: [-0.1, 0.7]t-test, 2 sided
p-value: 0.00695% CI: [-0.9, -0.2]t-test, 2 sided
p-value: 0.304595% CI: [-0.7, 0.2]t-test, 2 sided
p-value: 0.002995% CI: [-1, -0.2]t-test, 2 sided
p-value: 0.827495% CI: [-0.5, 0.4]t-test, 2 sided
p-value: 0.034995% CI: [0, 0.9]t-test, 2 sided
p-value: 0.345195% CI: [-0.2, 0.6]t-test, 2 sided
p-value: 0.000695% CI: [-1.2, -0.3]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data, n=4 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)Week 23.98 units on a scaleStandard Deviation 0.76
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)Baseline4.08 units on a scaleStandard Deviation 0.67
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)Week 64 units on a scaleStandard Deviation 0.99
p-value: 0.2595% CI: [-0.3, 0.1]t-test, 2 sided
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).

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=4 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)DBI positive expectancies - Baseline56.59 units on a scaleStandard Deviation 19.89
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)DBI positive expectancies - Week 245.01 units on a scaleStandard Deviation 23.96
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)DBI positive expectancies - Week 635.97 units on a scaleStandard Deviation 29.49
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)DBI negative expectancies - Baseline68.61 units on a scaleStandard Deviation 26.24
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)DBI negative expectancies - Week 266.44 units on a scaleStandard Deviation 26.25
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)DBI negative expectancies - Week 666.17 units on a scaleStandard Deviation 28.93
p-value: <0.000195% CI: [-27.2, -14.3]t-test, 2 sided
p-value: 0.2795% CI: [-8.1, 2.3]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=4 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS total scores - Baseline19.26 score on a scaleStandard Deviation 7.51
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS Perceived helplessness - Week 61.78 score on a scaleStandard Deviation 1.03
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS Perceived self-efficacy - Week 22.53 score on a scaleStandard Deviation 0.8
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS total scores - Week 217.46 score on a scaleStandard Deviation 7.39
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS total scores - Week 616.77 score on a scaleStandard Deviation 8.66
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS Perceived helplessness - Baseline2.10 score on a scaleStandard Deviation 0.93
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS Perceived helplessness - Week 21.93 score on a scaleStandard Deviation 0.92
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS Perceived self-efficacy - Baseline2.34 score on a scaleStandard Deviation 0.85
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)PSS Perceived self-efficacy - Week 62.48 score on a scaleStandard Deviation 0.94
p-value: 0.006995% CI: [-4.1, -0.7]t-test, 2 sided
p-value: 0.004395% CI: [-0.5, -0.1]t-test, 2 sided
p-value: 0.195395% CI: [-0.1, 0.4]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data, n=6 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)PANAS - Positive Affect - Week 63.59 units on a scaleStandard Deviation 0.9
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)PANAS - Negative Affect - Baseline2.32 units on a scaleStandard Deviation 1.02
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)PANAS - Positive Affect - Baseline3.39 units on a scaleStandard Deviation 0.82
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)PANAS - Positive Affect - Week 23.47 units on a scaleStandard Deviation 0.77
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)PANAS - Negative Affect - Week 22.13 units on a scaleStandard Deviation 0.79
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)PANAS - Negative Affect - Week 62.18 units on a scaleStandard Deviation 1.1
Comparison: PANAS positive affectp-value: 0.0695% CI: [0, 0.4]t-test, 2 sided
Comparison: PANAS negative affectp-value: 0.3695% CI: [-0.4, 0.1]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: Some participants had missing data for follow-up time-points. In the statistical analysis, we used hierarchical linear mixed models with maximum likelihood estimation to handle missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)Baseline3.66 units on a scaleStandard Deviation 1.36
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)Week 22.50 units on a scaleStandard Deviation 1.38
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)Week 62.18 units on a scaleStandard Deviation 1.57
p-value: <0.000195% CI: [-1.9, -1.1]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data, n=4 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)SEQ Internal Cues - Baseline53.44 units on a scaleStandard Deviation 22.04
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)SEQ Internal Cues - Week 260.15 units on a scaleStandard Deviation 23.33
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)SEQ Internal Cues - Week 666.98 units on a scaleStandard Deviation 29.09
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)SEQ External Cues - Baseline58.89 units on a scaleStandard Deviation 21.1
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)SEQ External Cues - Week 264.75 units on a scaleStandard Deviation 23.31
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)SEQ External Cues - Week 670.64 units on a scaleStandard Deviation 26.92
Comparison: SEQ-12 - Internalp-value: <0.000195% CI: [7.6, 18.7]t-test, 2 sided
Comparison: SEQ-12 - Externalp-value: <0.000195% CI: [6.1, 16.1]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data, n=4 were missing Week 2 data, n=7 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresHappiness Past Week - Baseline67.74 units on a scaleStandard Deviation 21.5
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresHappiness Past Week - Week 267.75 units on a scaleStandard Deviation 21.88
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresHappiness Past Week - Week 669.69 units on a scaleStandard Deviation 23.91
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresHappiness Right Now - Baseline70.04 units on a scaleStandard Deviation 20.38
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresHappiness Right Now - Week 268.55 units on a scaleStandard Deviation 25.34
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresHappiness Right Now - Week 670.03 units on a scaleStandard Deviation 24.93
Comparison: Single-item - past weekp-value: 0.6295% CI: [-3.8, 6.3]t-test, 2 sided
Comparison: Single-item - right nowp-value: 0.8395% CI: [-5.4, 4.4]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=4 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit MeasureBaseline88.04 units on a scaleStandard Deviation 14.57
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit Measure2-week83.74 units on a scaleStandard Deviation 18.36
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit Measure6-week81.73 units on a scaleStandard Deviation 22.61
p-value: 0.005395% CI: [-11.1, -2]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=4 and n=5 participants had missing data at weeks 2 and 6, respectively. Data was analyzed in a hierarchical mixed model with maximum likelihood estimation to handle missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking MeasuresPros of being smoke-free - Baseline84.90 units on a scaleStandard Deviation 21.12
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking MeasuresPros of being smoke-free - Week 280.40 units on a scaleStandard Deviation 25.16
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking MeasuresPros of being smoke-free - Week 675.71 units on a scaleStandard Deviation 31.01
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking MeasuresCons of being smoke-free - Baseline63.40 units on a scaleStandard Deviation 32.25
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking MeasuresCons of being smoke-free - Week 264.40 units on a scaleStandard Deviation 31.44
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking MeasuresCons of being smoke-free - Week 658.51 units on a scaleStandard Deviation 35.8
p-value: 0.00995% CI: [-15.9, -2.3]t-test, 2 sided
p-value: 0.2595% CI: [-13.7, 3.6]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data, n=4 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy Measure2-week76.91 units on a scaleStandard Deviation 19.42
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy Measure6-week81.22 units on a scaleStandard Deviation 22.16
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy MeasureBaseline75.71 units on a scaleStandard Deviation 20.05
p-value: 0.012695% CI: [1.2, 9.8]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 participants were missing baseline data for this survey; n=4 and n=6 participants had missing data at weeks 2 and 6, respectively. Data was analyzed in a hierarchical mixed model with maximum likelihood estimation to handle missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges MeasureBaseline50.87 units on a scaleStandard Deviation 27.03
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges MeasureWeek 231.27 units on a scaleStandard Deviation 29.31
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges MeasureWeek 626.12 units on a scaleStandard Deviation 30.9
p-value: <0.000195% CI: [-32.7, -17.1]t-test, 2 sided
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.

Time frame: Baseline, 2-weeks, and 6-weeks post-quit

Population: n=1 had incomplete baseline data, n=6 were missing Week 2 data, n=5 were missing Week 6 data

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)Baseline4.77 units on a scaleStandard Deviation 1.39
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)Week 24.81 units on a scaleStandard Deviation 1.38
Smiling Instead of Smoking (SiS) App Version 2Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)Week 64.94 units on a scaleStandard Deviation 1.42
p-value: 0.162795% CI: [-0.1, 0.4]t-test, 2 sided
Other Pre-specified

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.

Time frame: 6 weeks after chosen smoking cessation date

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of Smoking (SiS) App Version 2Features of App That Need Improvement - App Usage24.7 days on which app was used at least onceStandard Deviation 13.8
Other Pre-specified

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.

Time frame: Baseline, 2 weeks post-quit, 6 weeks post-quit, 3-months post-quit, 6-months post-quit

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Smiling Instead of Smoking (SiS) App Version 2Self-reported Smoking StatusBaseline0 Participants
Smiling Instead of Smoking (SiS) App Version 2Self-reported Smoking Status2 weeks post-quit1 Participants
Smiling Instead of Smoking (SiS) App Version 2Self-reported Smoking Status6 weeks post-quit40 Participants
Smiling Instead of Smoking (SiS) App Version 2Self-reported Smoking Status3-months post-quit56 Participants
Smiling Instead of Smoking (SiS) App Version 2Self-reported Smoking Status6-months post-quit56 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026