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A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App Smiling Instead of Smoking (SiS)

A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App Smiling Instead of Smoking (SiS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04672239
Enrollment
229
Registered
2020-12-17
Start date
2021-01-28
Completion date
2023-01-06
Last updated
2024-09-19

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

Conditions

Nondaily Smoking

Keywords

nondaily smoking, smartphone app, smoking cessation, QuitGuide, Smiling instead of Smoking, SiS, positive psychology, mHealth

Brief summary

This is the third study in a series of 3 studies to develop a smartphone app to support nondaily smokers in quitting smoking, as funded by the American Cancer Society grant #RSG CPPB - 130323 (project dates: 07/01/2017 - 6/30/2021). Study 1 (2017P001106) demonstrated feasibility and acceptability when smokers were onboarded in person. Study 2 (2018P002699) demonstrated feasibility and acceptability when smokers were onboarded remotely, nationwide. The present study is Study 3. It is a 3-group proof-of-concept RCT, in which we seek to test if our app (i.e., Version 3 of our developed smartphone app, called 'Smiling instead of Smoking' (SiS)) is superior to treatment as usual (i.e., TAU) and superior to a control app (i.e., the National Cancer Institute's smartphone app QuitGuide (QG).

Detailed description

This is a nation-wide proof-of-concept randomized controlled trial conducted entirely remotely. Participation will last 6 months and entails: * Completing a scripted onboarding call (approximately 30-45 minutes) * Making a quit attempt * Engaging with smoking cessation support (randomized) over the course of seven weeks, one week prior and 6 weeks following the originally chosen quit day * Completing five online, REDCap-administered surveys, 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 The Aims of the study are: 1. Test for differences between randomized groups on the primary outcome (i.e., self-efficacy to remain abstinent, as measured via the Smoking Self-Efficacy Questionnaire), as measured at end of treatment (i.e., 6 weeks after the participants' chosen smoking quit day) 2. Test for differences between randomized groups on secondary outcomes (as listed in Detailed Protocol) 3. (exploratory) To test, via mediational modeling, how treatment via the proposed app conferred benefit; or, if not effective, if failure is due to the treatment failing to impact hypothesized mechanisms of change, or because these mechanisms fail to impact outcome.

Interventions

BEHAVIORALSmartphone app Smiling instead of Smoking (SiS) Version 3

Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.

BEHAVIORALSmartphone app QuitGuide (QG)

Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.

BEHAVIORALBrochure Clearing the Air (CTA)

Participants will be onboarded to the brochure Clearing the Air and will be asked to use it for 7 weeks to support them in quitting smoking.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

3-group proof-of-concept RCT

Eligibility

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

Inclusion criteria

* 18+ years of age * smartphone ownership (Android or iPhone only) * current nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days * lifetime history of having smoked 100+ cigarettes * willing to make a smoking quit attempt * currently residing in the United States of America

Exclusion criteria

* Under 18 years of age * Does not own an Android or iPhone * 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 lifetime history of having smoked 100+ cigarettes * Is not willing to make a smoking quit attempt * Is not currently residing in the United States of America

Design outcomes

Primary

MeasureTime frameDescription
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Up to 24 weeks post quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (baseline = week -1).The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, & Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking.

Secondary

MeasureTime frameDescription
Perceived Impact of the Provided Materials on QuittingAssessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).Assessed using a study-specific, unpublished 17-item measure in which participants rated the extent to which they agreed or disagreed with statements about the helpfulness of their assigned app during the quitting process (e.g., \[the app\]...gave me confidence that I can quit smoking., \[the app\]... made me feel that I knew the right steps to take to quit., and \[the app\] ...reminded me in crucial moments to stay quit.). Items were rated on 5-point Likert scales ranging from 1=strongly disagree to 5=strongly agree. The scores of the 17 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with perceived impact of the smoking cessation support their assigned app provided (i.e., a more positive outcome).
AppreciationAssessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).As measured using the Appreciation Scale, (Adler & Fagley, 2005) an 18-item scale assessing the degree to which one is appreciative. Ten of the items assess frequency of action (e.g., I do things to remind myself to be thankful, using a 7-point Likert scale of: 1 = More than once a day to 7 = Never). The remaining eight items assess level of agreement with appreciative statements (e.g., I feel that it is a miracle to be alive, using a 7-point Likert scale of: 1 = Strongly agree to 7 = Strongly disagree). Item scores were summed to a total score with a possible range from 18 to 126 where higher scores indicate greater appreciation.
Actual App Usage (SiS and QG Only)Cumulative from week 0 to week 24 post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).Number of days participants used the assigned app during the prescribed period of app use (i.e., 7 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.
Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)From week 3 to week 6 post-quit. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).This was assessed via self-reported estimates of app use. Participants were asked on how many days they used the app in weeks 4, 5, and 6 post-quit (On how many days per week did you use the app?), and for how many minutes per typical day they used the assigned app (On the days you used the app, how many minutes per day did you interact with the app?). The days per week were multiplied by the minutes per app-use-day for each week, then averaged across the three weeks.
Likability Rating of the App (SiS and QG Only)Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).Measured using the single item, How much did you like using the smoking cessation app we asked you to use? Participants respond on a 5-point Likert scale (1 = I strongly disliked using the app, 2 = I somewhat disliked using the app, 3 = I neither liked nor disliked using the app; 4 = I somewhat liked using the app, and 5 = I strongly liked using the app).
Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only)Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).Measured using the single item, How satisfied are you with the smoking cessation support this app provided you with? Participants respond on a 5-point Likert scale (1 = very unsatisfied, 2 = somewhat dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = somewhat satisfied, 5 = very satisfied).
App Usability Ratings (SiS and QG Only)Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).As assessed via the System Usability Scale (SUS; Brooke, 1996), a ten-item attitude scale giving a global view of subjective assessments of usability, adapted to include language specific to the smoking app (e.g., I found the smoking app unnecessarily complex 5-point Likert: 1 = strongly disagree, 5 = strongly agree). Scale scores range from 0 to 100 with greater scores indicating a more favorable perception of usability of the app.
Self-reported 30-day Point-prevalence AbstinenceAssessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).Participants responded to the multiple choice question, What is your current smoking status? with answer options: I smoke daily, I smoke non-daily (and have smoked in the past 7 days), I smoke nondaily (but have NOT smoked in the past 7 days), and I do not smoke at all). If participants reported that they did not smoke at all, they were asked: Have you been abstinent during the past 30 days? (yes/no). All participants who reported smoking daily or nondaily to the first question, or who reported not smoking at all but had smoking in the past 30 days, or those who left either of those questions unanswered were marked as NOT 30-day point prevalent smoking abstinent (not included in the abstinent count below). People who reported not smoking at all and being smoking-abstinent for the past 30 days were marked as 30-day point prevalent smoking abstinent (include in the abstinent count below).
Self-reported Past Week Cigarette ChangeAssessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).If participants report having smoked in the past 7 days, they were asked to indicate how many cigarettes they smoked each day (Last Monday:, Last Sunday:). Changes in cigarette consumption were calculated by subtracting the number of cigarettes smoked in the week leading up to the baseline assessment, as measured in the baseline survey, from the number of cigarettes smoked in the week leading up to the 2, 6, 12, and 24 week post-quit assessments, as assessed in these respective surveys.
Time Spent Applying Content Brought up by the Apps/Clearing the AirAssessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).Measured using the following single item, During this past week, how much time did you spend applying or contemplating the content of the SiS app/QG app/Clearing the Air? \[in minutes\].
Use of Smoking Cessation StrategiesAssessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).Assessed using a study-specific, unpublished 8-item measure in which participants rated the extent to which they agreed or disagreed with statements about the smoking cessation support they received and the things they did while quitting (5-point Likert scale, 1=strongly disagree, 5=strongly agree, e.g., I used \[the assigned treatment\] the way I was supposed to (in the days leading up to and following my quit attempt). and I avoided situations that would make me want to smoke.). The scores of the 8 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with the use of a larger combination of smoking cessation strategies (i.e., a more positive outcome).
Satisfaction With Smoking Cessation SupportAssessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).As measured using the Client Satisfaction Scale (CSQ-8) (Larsen, 1979), an 8 item multiple choice measure that will be used to assess participants' satisfaction with the smoking cessation support they receive (e.g., How satisfied are you with the amount of help you received?). Scores are summed across items and range from 8 to 32, with higher scores indicating greater satisfaction.

Countries

United States

Participant flow

Pre-assignment details

One participant in each treatment arm decided against the study during the onboarding process and before starting any study procedures. These were excluded from analysis in a modified intent to treat approach for an enrolled and active sample of n=226.

Participants by arm

ArmCount
SiS App Treatment
Participants were onboarded (remotely) to the smartphone app Smiling instead of Smoking (SiS) Version 3, and were asked to use it for 7 weeks while they quit smoking.
80
QG App Treatment
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) smartphone app QuitGuide (QG), and were asked to use it for 7 weeks while they quit smoking.
75
CTA Pamphlet
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure Clearing the Air (CTA), and were asked to use it for 7 weeks while they quit smoking.
71
Total226

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
3-Month Follow-up SurveyFailed survey check items232
3-Month Follow-up SurveyLost to Follow-up17511
3-Month Follow-up SurveyPartially completed survey313
3-Month Follow-up SurveyWithdrawal by Subject011
6-Month Follow-up SurveyFailed survey check items200
6-Month Follow-up SurveyLost to Follow-up13129
6-Month Follow-up SurveyPartially completed survey702
Week 2 SurveyFailed survey check items123
Week 2 SurveyLost to Follow-up325
Week 2 SurveyPartially completed survey714
Week 2 SurveyWithdrawal by Subject010
Week 6 SurveyFailed survey check items222
Week 6 SurveyLost to Follow-up1225
Week 6 SurveyPartially completed survey332
Week 6 SurveyWithdrawal by Subject111
Week 6 SurveyWithdrawn by PI010

Baseline characteristics

CharacteristicSiS App TreatmentQG App TreatmentCTA PamphletTotal
Age, Continuous41.3 years
STANDARD_DEVIATION 11.1
41.6 years
STANDARD_DEVIATION 13.1
40.0 years
STANDARD_DEVIATION 12.5
41.0 years
STANDARD_DEVIATION 12.2
Anhedonia
No
68 Participants57 Participants53 Participants178 Participants
Anhedonia
Yes
11 Participants18 Participants17 Participants46 Participants
Any alcohol in the past 30 days
No
35 Participants38 Participants31 Participants104 Participants
Any alcohol in the past 30 days
Yes
45 Participants37 Participants40 Participants122 Participants
Any binge drinking in the past 30 days
No
55 Participants60 Participants53 Participants168 Participants
Any binge drinking in the past 30 days
Yes
25 Participants15 Participants18 Participants58 Participants
Any weeks of exceeding the drinking guidelines in the past 30 days
No
57 Participants57 Participants52 Participants166 Participants
Any weeks of exceeding the drinking guidelines in the past 30 days
Yes
23 Participants18 Participants19 Participants60 Participants
CES-D total scores8.0 units on a scale9.0 units on a scale11.0 units on a scale9.0 units on a scale
Cigarettes per smoking day3.5 cigarettes per day
STANDARD_DEVIATION 2.9
3.0 cigarettes per day
STANDARD_DEVIATION 2.2
3.8 cigarettes per day
STANDARD_DEVIATION 3
3.4 cigarettes per day
STANDARD_DEVIATION 2.7
Currently uses electronic cigarettes
No
66 Participants65 Participants62 Participants193 Participants
Currently uses electronic cigarettes
Yes
14 Participants10 Participants9 Participants33 Participants
Employment
Declined to answer
5 Participants1 Participants3 Participants9 Participants
Employment
Full-time
29 Participants30 Participants27 Participants86 Participants
Employment
Part-time
14 Participants11 Participants18 Participants43 Participants
Employment
Unemployed
32 Participants33 Participants23 Participants88 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants16 Participants6 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
62 Participants57 Participants64 Participants183 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants1 Participants6 Participants
Ever smoked daily?
Declined to answer
1 Participants0 Participants0 Participants1 Participants
Ever smoked daily?
No
25 Participants22 Participants27 Participants74 Participants
Ever smoked daily?
Yes
54 Participants53 Participants44 Participants151 Participants
Ever told they had a mental health or psychological condition
No
56 Participants52 Participants49 Participants157 Participants
Ever told they had a mental health or psychological condition
Yes
24 Participants23 Participants22 Participants69 Participants
Ever tried to quit smoking before
No
31 Participants19 Participants19 Participants69 Participants
Ever tried to quit smoking before
Yes
49 Participants56 Participants52 Participants157 Participants
Ever used electronic cigarettes
No
34 Participants34 Participants25 Participants93 Participants
Ever used electronic cigarettes
Yes
46 Participants41 Participants46 Participants133 Participants
Fagerstrom Test for Nicotine Dependence, total score1.0 units on a scale1.0 units on a scale1.0 units on a scale1.0 units on a scale
GAD-7 total scores5.7 units on a scale
STANDARD_DEVIATION 4.8
6.5 units on a scale
STANDARD_DEVIATION 5.4
7.2 units on a scale
STANDARD_DEVIATION 5.1
6.4 units on a scale
STANDARD_DEVIATION 5.1
GSES total scores31.9 units on a scale
STANDARD_DEVIATION 5
31.7 units on a scale
STANDARD_DEVIATION 4.9
30.8 units on a scale
STANDARD_DEVIATION 4.7
31.5 units on a scale
STANDARD_DEVIATION 4.9
Highest level of education completed
College degree or higher
42 Participants25 Participants30 Participants97 Participants
Highest level of education completed
Declined to answer
0 Participants0 Participants1 Participants1 Participants
Highest level of education completed
High School or less
7 Participants12 Participants15 Participants34 Participants
Highest level of education completed
Some college
31 Participants38 Participants25 Participants94 Participants
Household Income
$100,000 or more
4 Participants7 Participants8 Participants19 Participants
Household Income
$39,999 or less
41 Participants42 Participants30 Participants113 Participants
Household Income
$40,000 - 69,999
18 Participants18 Participants22 Participants58 Participants
Household Income
$70,000 - 99,999
16 Participants8 Participants10 Participants34 Participants
Household Income
Declined to answer
1 Participants0 Participants1 Participants2 Participants
Number of days smoked in past 30 days15.3 number of days
STANDARD_DEVIATION 5.4
14.7 number of days
STANDARD_DEVIATION 4.8
14.6 number of days
STANDARD_DEVIATION 4.5
14.9 number of days
STANDARD_DEVIATION 4.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants4 Participants6 Participants
Race (NIH/OMB)
Black or African American
23 Participants19 Participants13 Participants55 Participants
Race (NIH/OMB)
More than one race
4 Participants6 Participants4 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants6 Participants
Race (NIH/OMB)
White
50 Participants46 Participants48 Participants144 Participants
Rurality
Rural
12 Participants17 Participants9 Participants38 Participants
Rurality
Suburban
29 Participants24 Participants35 Participants88 Participants
Rurality
Urban
39 Participants34 Participants27 Participants100 Participants
Sex/Gender, Customized
Female
51 Participants36 Participants41 Participants128 Participants
Sex/Gender, Customized
Male
28 Participants37 Participants30 Participants95 Participants
Sex/Gender, Customized
Other
1 Participants2 Participants0 Participants3 Participants
SIMP - Agreeableness6.6 units on a scale
STANDARD_DEVIATION 1.9
6.2 units on a scale
STANDARD_DEVIATION 2.4
6.4 units on a scale
STANDARD_DEVIATION 2.1
6.4 units on a scale
STANDARD_DEVIATION 2.1
SIMP - Conscientiousness5.2 units on a scale
STANDARD_DEVIATION 2.6
5.2 units on a scale
STANDARD_DEVIATION 2.3
5.7 units on a scale
STANDARD_DEVIATION 2.3
5.4 units on a scale
STANDARD_DEVIATION 2.4
SIMP - Emotional stability5.1 units on a scale
STANDARD_DEVIATION 2.4
4.7 units on a scale
STANDARD_DEVIATION 2.2
4.4 units on a scale
STANDARD_DEVIATION 1.9
4.8 units on a scale
STANDARD_DEVIATION 2.2
SIMP - Extraversion5.5 units on a scale
STANDARD_DEVIATION 2.1
5.2 units on a scale
STANDARD_DEVIATION 2.5
5.1 units on a scale
STANDARD_DEVIATION 2.5
5.3 units on a scale
STANDARD_DEVIATION 2.4
SIMP - Openness3.9 units on a scale
STANDARD_DEVIATION 2.1
3.6 units on a scale
STANDARD_DEVIATION 2
4.1 units on a scale
STANDARD_DEVIATION 2.3
3.9 units on a scale
STANDARD_DEVIATION 2.1
US region
Midwest
10 Participants11 Participants10 Participants31 Participants
US region
Northeast
22 Participants15 Participants14 Participants51 Participants
US region
South
34 Participants34 Participants29 Participants97 Participants
US region
West
14 Participants15 Participants18 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 750 / 71
other
Total, other adverse events
0 / 800 / 750 / 71
serious
Total, serious adverse events
0 / 800 / 750 / 71

Outcome results

Primary

End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)

The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, & Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking.

Time frame: Up to 24 weeks post quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (baseline = week -1).

Population: Some participants had missing data at various assessment time-points, but all enrolled participants provided data for at least one assessment.

ArmMeasureGroupValue (MEAN)Dispersion
Smiling Instead of SmokingEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 12 post-quit (3-month follow-up)81.16 units on a scaleStandard Deviation 17.35
Smiling Instead of SmokingEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 6 post-quit78.34 units on a scaleStandard Deviation 17.31
Smiling Instead of SmokingEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Baseline63.81 units on a scaleStandard Deviation 17.24
Smiling Instead of SmokingEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 2 post-quit71.79 units on a scaleStandard Deviation 18.56
Smiling Instead of SmokingEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 24 post-quit (6-month follow-up)80.23 units on a scaleStandard Deviation 18.41
Quit GuideEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 6 post-quit71.34 units on a scaleStandard Deviation 17.67
Quit GuideEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Baseline60.74 units on a scaleStandard Deviation 16.67
Quit GuideEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 2 post-quit67.58 units on a scaleStandard Deviation 15.69
Quit GuideEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 12 post-quit (3-month follow-up)76.20 units on a scaleStandard Deviation 19.5
Quit GuideEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 24 post-quit (6-month follow-up)80.51 units on a scaleStandard Deviation 20.33
Clearing the AirEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 24 post-quit (6-month follow-up)74.48 units on a scaleStandard Deviation 23.42
Clearing the AirEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 12 post-quit (3-month follow-up)75.22 units on a scaleStandard Deviation 19.12
Clearing the AirEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Baseline58.45 units on a scaleStandard Deviation 19.1
Clearing the AirEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 6 post-quit68.99 units on a scaleStandard Deviation 19.8
Clearing the AirEnd of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Week 2 post-quit65.40 units on a scaleStandard Deviation 16.59
Comparison: This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.p-value: 0.021995% CI: [1.0734, 13.5948]Mixed Models Analysis
Comparison: This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.p-value: 0.007295% CI: [2.407, 15.148]Mixed Models Analysis
Secondary

Actual App Usage (SiS and QG Only)

Number of days participants used the assigned app during the prescribed period of app use (i.e., 7 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.

Time frame: Cumulative from week 0 to week 24 post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: All participants randomized to either of the app treatment groups (SiS or QG).

ArmMeasureValue (MEDIAN)
Smiling Instead of SmokingActual App Usage (SiS and QG Only)32.5 number of days of app use
Quit GuideActual App Usage (SiS and QG Only)26.0 number of days of app use
p-value: 0.4182Wilcoxon (Mann-Whitney)
Secondary

Appreciation

As measured using the Appreciation Scale, (Adler & Fagley, 2005) an 18-item scale assessing the degree to which one is appreciative. Ten of the items assess frequency of action (e.g., I do things to remind myself to be thankful, using a 7-point Likert scale of: 1 = More than once a day to 7 = Never). The remaining eight items assess level of agreement with appreciative statements (e.g., I feel that it is a miracle to be alive, using a 7-point Likert scale of: 1 = Strongly agree to 7 = Strongly disagree). Item scores were summed to a total score with a possible range from 18 to 126 where higher scores indicate greater appreciation.

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of SmokingAppreciation108.91 units on a scaleStandard Deviation 13.46
Quit GuideAppreciation106.28 units on a scaleStandard Deviation 15.29
Clearing the AirAppreciation104.98 units on a scaleStandard Deviation 14.26
p-value: 0.298895% CI: [-2.3458, 7.5968]t-test, 2 sided
p-value: 0.125195% CI: [-1.1015, 8.9569]t-test, 2 sided
Secondary

App Usability Ratings (SiS and QG Only)

As assessed via the System Usability Scale (SUS; Brooke, 1996), a ten-item attitude scale giving a global view of subjective assessments of usability, adapted to include language specific to the smoking app (e.g., I found the smoking app unnecessarily complex 5-point Likert: 1 = strongly disagree, 5 = strongly agree). Scale scores range from 0 to 100 with greater scores indicating a more favorable perception of usability of the app.

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants who were randomized to the two app treatment conditions (SiS and QuitGuide) and who completed the week 6 survey only.

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of SmokingApp Usability Ratings (SiS and QG Only)81.91 units on a scaleStandard Deviation 17.1
Quit GuideApp Usability Ratings (SiS and QG Only)79.48 units on a scaleStandard Deviation 15.99
p-value: 0.407895% CI: [-3.3597, 8.2188]t-test, 2 sided
Secondary

Likability Rating of the App (SiS and QG Only)

Measured using the single item, How much did you like using the smoking cessation app we asked you to use? Participants respond on a 5-point Likert scale (1 = I strongly disliked using the app, 2 = I somewhat disliked using the app, 3 = I neither liked nor disliked using the app; 4 = I somewhat liked using the app, and 5 = I strongly liked using the app).

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of SmokingLikability Rating of the App (SiS and QG Only)4.19 units on a scaleStandard Deviation 0.99
Quit GuideLikability Rating of the App (SiS and QG Only)4.08 units on a scaleStandard Deviation 0.87
p-value: 0.501895% CI: [-0.2143, 0.4354]t-test, 2 sided
Secondary

Perceived Impact of the Provided Materials on Quitting

Assessed using a study-specific, unpublished 17-item measure in which participants rated the extent to which they agreed or disagreed with statements about the helpfulness of their assigned app during the quitting process (e.g., \[the app\]...gave me confidence that I can quit smoking., \[the app\]... made me feel that I knew the right steps to take to quit., and \[the app\] ...reminded me in crucial moments to stay quit.). Items were rated on 5-point Likert scales ranging from 1=strongly disagree to 5=strongly agree. The scores of the 17 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with perceived impact of the smoking cessation support their assigned app provided (i.e., a more positive outcome).

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of SmokingPerceived Impact of the Provided Materials on Quitting4.13 units on a scaleStandard Deviation 0.72
Quit GuidePerceived Impact of the Provided Materials on Quitting3.98 units on a scaleStandard Deviation 0.55
Clearing the AirPerceived Impact of the Provided Materials on Quitting3.84 units on a scaleStandard Deviation 0.73
p-value: 0.199695% CI: [-0.08092, 0.3848]t-test, 2 sided
p-value: 0.015495% CI: [0.05636, 0.5276]t-test, 2 sided
Secondary

Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only)

Measured using the single item, How satisfied are you with the smoking cessation support this app provided you with? Participants respond on a 5-point Likert scale (1 = very unsatisfied, 2 = somewhat dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = somewhat satisfied, 5 = very satisfied).

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of SmokingSatisfaction Rating of the Smoking Cessation Support (SiS and QG Only)4.25 units on a scaleStandard Deviation 1.04
Quit GuideSatisfaction Rating of the Smoking Cessation Support (SiS and QG Only)4.11 units on a scaleStandard Deviation 0.94
p-value: 0.424695% CI: [-0.2068, 0.488]t-test, 2 sided
Secondary

Satisfaction With Smoking Cessation Support

As measured using the Client Satisfaction Scale (CSQ-8) (Larsen, 1979), an 8 item multiple choice measure that will be used to assess participants' satisfaction with the smoking cessation support they receive (e.g., How satisfied are you with the amount of help you received?). Scores are summed across items and range from 8 to 32, with higher scores indicating greater satisfaction.

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of SmokingSatisfaction With Smoking Cessation Support26.91 units on a scaleStandard Deviation 5.3
Quit GuideSatisfaction With Smoking Cessation Support26.61 units on a scaleStandard Deviation 4.51
Clearing the AirSatisfaction With Smoking Cessation Support25.65 units on a scaleStandard Deviation 5.8
p-value: 0.746995% CI: [-1.4983, 2.0856]t-test, 2 sided
p-value: 0.174795% CI: [-0.5628, 3.0766]t-test, 2 sided
Secondary

Self-reported 30-day Point-prevalence Abstinence

Participants responded to the multiple choice question, What is your current smoking status? with answer options: I smoke daily, I smoke non-daily (and have smoked in the past 7 days), I smoke nondaily (but have NOT smoked in the past 7 days), and I do not smoke at all). If participants reported that they did not smoke at all, they were asked: Have you been abstinent during the past 30 days? (yes/no). All participants who reported smoking daily or nondaily to the first question, or who reported not smoking at all but had smoking in the past 30 days, or those who left either of those questions unanswered were marked as NOT 30-day point prevalent smoking abstinent (not included in the abstinent count below). People who reported not smoking at all and being smoking-abstinent for the past 30 days were marked as 30-day point prevalent smoking abstinent (include in the abstinent count below).

Time frame: Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were assumed to be smoking (i.e., not 30-day point-prevalent abstinent from smoking).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Smiling Instead of SmokingSelf-reported 30-day Point-prevalence AbstinenceWeek 6 post-quit32 Participants
Smiling Instead of SmokingSelf-reported 30-day Point-prevalence AbstinenceWeek 12 post-quit (3-month follow-up)36 Participants
Smiling Instead of SmokingSelf-reported 30-day Point-prevalence AbstinenceWeek 24 post-quit (6-month follow-up)38 Participants
Smiling Instead of SmokingSelf-reported 30-day Point-prevalence AbstinenceWeek 2 post-quit9 Participants
Quit GuideSelf-reported 30-day Point-prevalence AbstinenceWeek 6 post-quit23 Participants
Quit GuideSelf-reported 30-day Point-prevalence AbstinenceWeek 2 post-quit3 Participants
Quit GuideSelf-reported 30-day Point-prevalence AbstinenceWeek 12 post-quit (3-month follow-up)31 Participants
Quit GuideSelf-reported 30-day Point-prevalence AbstinenceWeek 24 post-quit (6-month follow-up)32 Participants
Clearing the AirSelf-reported 30-day Point-prevalence AbstinenceWeek 12 post-quit (3-month follow-up)21 Participants
Clearing the AirSelf-reported 30-day Point-prevalence AbstinenceWeek 24 post-quit (6-month follow-up)31 Participants
Clearing the AirSelf-reported 30-day Point-prevalence AbstinenceWeek 2 post-quit9 Participants
Clearing the AirSelf-reported 30-day Point-prevalence AbstinenceWeek 6 post-quit18 Participants
Comparison: This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the QuitGuide app treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., end-of-treatment).p-value: 0.225995% CI: [0.7759, 2.9281]Generalized Linear Model
Comparison: This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the Clearing the Air pamphlet treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., post-treatment).p-value: 0.057995% CI: [0.9776, 3.9415]Generalized Linear Model
Secondary

Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)

This was assessed via self-reported estimates of app use. Participants were asked on how many days they used the app in weeks 4, 5, and 6 post-quit (On how many days per week did you use the app?), and for how many minutes per typical day they used the assigned app (On the days you used the app, how many minutes per day did you interact with the app?). The days per week were multiplied by the minutes per app-use-day for each week, then averaged across the three weeks.

Time frame: From week 3 to week 6 post-quit. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded.

ArmMeasureValue (MEDIAN)
Smiling Instead of SmokingSelf-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)35.0 average minutes per week
Quit GuideSelf-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)22.5 average minutes per week
p-value: 0.0563Wilcoxon (Mann-Whitney)
Secondary

Self-reported Past Week Cigarette Change

If participants report having smoked in the past 7 days, they were asked to indicate how many cigarettes they smoked each day (Last Monday:, Last Sunday:). Changes in cigarette consumption were calculated by subtracting the number of cigarettes smoked in the week leading up to the baseline assessment, as measured in the baseline survey, from the number of cigarettes smoked in the week leading up to the 2, 6, 12, and 24 week post-quit assessments, as assessed in these respective surveys.

Time frame: Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: All available survey data at each assessment was used; by week 2 post-quit several participants had missing data for that and all subsequent assessments (n=3 for the SiS app, n=2 for the QG app, and n=3 for the CTA pamphlet groups).

ArmMeasureGroupValue (MEDIAN)
Smiling Instead of SmokingSelf-reported Past Week Cigarette ChangeWeek 12 post-quit (3-month follow-up)-6.0 Change in weekly cigs since baseline
Smiling Instead of SmokingSelf-reported Past Week Cigarette ChangeWeek 6 post-quit-5.0 Change in weekly cigs since baseline
Smiling Instead of SmokingSelf-reported Past Week Cigarette ChangeWeek 24 post-quit (6-month follow-up)-6.0 Change in weekly cigs since baseline
Smiling Instead of SmokingSelf-reported Past Week Cigarette ChangeWeek 2 post-quit-6.0 Change in weekly cigs since baseline
Quit GuideSelf-reported Past Week Cigarette ChangeWeek 6 post-quit-6.0 Change in weekly cigs since baseline
Quit GuideSelf-reported Past Week Cigarette ChangeWeek 2 post-quit-6.0 Change in weekly cigs since baseline
Quit GuideSelf-reported Past Week Cigarette ChangeWeek 12 post-quit (3-month follow-up)-6.0 Change in weekly cigs since baseline
Quit GuideSelf-reported Past Week Cigarette ChangeWeek 24 post-quit (6-month follow-up)-6.0 Change in weekly cigs since baseline
Clearing the AirSelf-reported Past Week Cigarette ChangeWeek 12 post-quit (3-month follow-up)-7.0 Change in weekly cigs since baseline
Clearing the AirSelf-reported Past Week Cigarette ChangeWeek 24 post-quit (6-month follow-up)-7.0 Change in weekly cigs since baseline
Clearing the AirSelf-reported Past Week Cigarette ChangeWeek 2 post-quit-7.0 Change in weekly cigs since baseline
Clearing the AirSelf-reported Past Week Cigarette ChangeWeek 6 post-quit-7.0 Change in weekly cigs since baseline
p-value: 0.9152Wilcoxon (Mann-Whitney)
p-value: 0.3557Wilcoxon (Mann-Whitney)
Secondary

Time Spent Applying Content Brought up by the Apps/Clearing the Air

Measured using the following single item, During this past week, how much time did you spend applying or contemplating the content of the SiS app/QG app/Clearing the Air? \[in minutes\].

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

ArmMeasureValue (MEDIAN)
Smiling Instead of SmokingTime Spent Applying Content Brought up by the Apps/Clearing the Air30.0 minutes per week
Quit GuideTime Spent Applying Content Brought up by the Apps/Clearing the Air25.0 minutes per week
Clearing the AirTime Spent Applying Content Brought up by the Apps/Clearing the Air30.0 minutes per week
p-value: 0.1315Wilcoxon (Mann-Whitney)
p-value: 0.3403Wilcoxon (Mann-Whitney)
Secondary

Use of Smoking Cessation Strategies

Assessed using a study-specific, unpublished 8-item measure in which participants rated the extent to which they agreed or disagreed with statements about the smoking cessation support they received and the things they did while quitting (5-point Likert scale, 1=strongly disagree, 5=strongly agree, e.g., I used \[the assigned treatment\] the way I was supposed to (in the days leading up to and following my quit attempt). and I avoided situations that would make me want to smoke.). The scores of the 8 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with the use of a larger combination of smoking cessation strategies (i.e., a more positive outcome).

Time frame: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

ArmMeasureValue (MEAN)Dispersion
Smiling Instead of SmokingUse of Smoking Cessation Strategies4.13 units on a scaleStandard Deviation 0.63
Quit GuideUse of Smoking Cessation Strategies3.90 units on a scaleStandard Deviation 0.59
Clearing the AirUse of Smoking Cessation Strategies3.97 units on a scaleStandard Deviation 0.69
p-value: 0.042995% CI: [0.007364, 0.4505]t-test, 2 sided
p-value: 0.1695% CI: [-0.06415, 0.386]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026