Nondaily Smoking
Conditions
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
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.
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.
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
Study design
Intervention model description
3-group proof-of-concept RCT
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Perceived Impact of the Provided Materials on Quitting | 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). | 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). |
| Appreciation | 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 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 Abstinence | 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). | 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 Change | 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). | 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 Air | 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 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 Strategies | 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). | 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 Support | 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 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
| Arm | Count |
|---|---|
| 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 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 3-Month Follow-up Survey | Failed survey check items | 2 | 3 | 2 |
| 3-Month Follow-up Survey | Lost to Follow-up | 17 | 5 | 11 |
| 3-Month Follow-up Survey | Partially completed survey | 3 | 1 | 3 |
| 3-Month Follow-up Survey | Withdrawal by Subject | 0 | 1 | 1 |
| 6-Month Follow-up Survey | Failed survey check items | 2 | 0 | 0 |
| 6-Month Follow-up Survey | Lost to Follow-up | 13 | 12 | 9 |
| 6-Month Follow-up Survey | Partially completed survey | 7 | 0 | 2 |
| Week 2 Survey | Failed survey check items | 1 | 2 | 3 |
| Week 2 Survey | Lost to Follow-up | 3 | 2 | 5 |
| Week 2 Survey | Partially completed survey | 7 | 1 | 4 |
| Week 2 Survey | Withdrawal by Subject | 0 | 1 | 0 |
| Week 6 Survey | Failed survey check items | 2 | 2 | 2 |
| Week 6 Survey | Lost to Follow-up | 12 | 2 | 5 |
| Week 6 Survey | Partially completed survey | 3 | 3 | 2 |
| Week 6 Survey | Withdrawal by Subject | 1 | 1 | 1 |
| Week 6 Survey | Withdrawn by PI | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | SiS App Treatment | QG App Treatment | CTA Pamphlet | Total |
|---|---|---|---|---|
| Age, Continuous | 41.3 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 Participants | 57 Participants | 53 Participants | 178 Participants |
| Anhedonia Yes | 11 Participants | 18 Participants | 17 Participants | 46 Participants |
| Any alcohol in the past 30 days No | 35 Participants | 38 Participants | 31 Participants | 104 Participants |
| Any alcohol in the past 30 days Yes | 45 Participants | 37 Participants | 40 Participants | 122 Participants |
| Any binge drinking in the past 30 days No | 55 Participants | 60 Participants | 53 Participants | 168 Participants |
| Any binge drinking in the past 30 days Yes | 25 Participants | 15 Participants | 18 Participants | 58 Participants |
| Any weeks of exceeding the drinking guidelines in the past 30 days No | 57 Participants | 57 Participants | 52 Participants | 166 Participants |
| Any weeks of exceeding the drinking guidelines in the past 30 days Yes | 23 Participants | 18 Participants | 19 Participants | 60 Participants |
| CES-D total scores | 8.0 units on a scale | 9.0 units on a scale | 11.0 units on a scale | 9.0 units on a scale |
| Cigarettes per smoking day | 3.5 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 Participants | 65 Participants | 62 Participants | 193 Participants |
| Currently uses electronic cigarettes Yes | 14 Participants | 10 Participants | 9 Participants | 33 Participants |
| Employment Declined to answer | 5 Participants | 1 Participants | 3 Participants | 9 Participants |
| Employment Full-time | 29 Participants | 30 Participants | 27 Participants | 86 Participants |
| Employment Part-time | 14 Participants | 11 Participants | 18 Participants | 43 Participants |
| Employment Unemployed | 32 Participants | 33 Participants | 23 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 16 Participants | 6 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 57 Participants | 64 Participants | 183 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Ever smoked daily? Declined to answer | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ever smoked daily? No | 25 Participants | 22 Participants | 27 Participants | 74 Participants |
| Ever smoked daily? Yes | 54 Participants | 53 Participants | 44 Participants | 151 Participants |
| Ever told they had a mental health or psychological condition No | 56 Participants | 52 Participants | 49 Participants | 157 Participants |
| Ever told they had a mental health or psychological condition Yes | 24 Participants | 23 Participants | 22 Participants | 69 Participants |
| Ever tried to quit smoking before No | 31 Participants | 19 Participants | 19 Participants | 69 Participants |
| Ever tried to quit smoking before Yes | 49 Participants | 56 Participants | 52 Participants | 157 Participants |
| Ever used electronic cigarettes No | 34 Participants | 34 Participants | 25 Participants | 93 Participants |
| Ever used electronic cigarettes Yes | 46 Participants | 41 Participants | 46 Participants | 133 Participants |
| Fagerstrom Test for Nicotine Dependence, total score | 1.0 units on a scale | 1.0 units on a scale | 1.0 units on a scale | 1.0 units on a scale |
| GAD-7 total scores | 5.7 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 scores | 31.9 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 Participants | 25 Participants | 30 Participants | 97 Participants |
| Highest level of education completed Declined to answer | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Highest level of education completed High School or less | 7 Participants | 12 Participants | 15 Participants | 34 Participants |
| Highest level of education completed Some college | 31 Participants | 38 Participants | 25 Participants | 94 Participants |
| Household Income $100,000 or more | 4 Participants | 7 Participants | 8 Participants | 19 Participants |
| Household Income $39,999 or less | 41 Participants | 42 Participants | 30 Participants | 113 Participants |
| Household Income $40,000 - 69,999 | 18 Participants | 18 Participants | 22 Participants | 58 Participants |
| Household Income $70,000 - 99,999 | 16 Participants | 8 Participants | 10 Participants | 34 Participants |
| Household Income Declined to answer | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Number of days smoked in past 30 days | 15.3 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 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 19 Participants | 13 Participants | 55 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 6 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 50 Participants | 46 Participants | 48 Participants | 144 Participants |
| Rurality Rural | 12 Participants | 17 Participants | 9 Participants | 38 Participants |
| Rurality Suburban | 29 Participants | 24 Participants | 35 Participants | 88 Participants |
| Rurality Urban | 39 Participants | 34 Participants | 27 Participants | 100 Participants |
| Sex/Gender, Customized Female | 51 Participants | 36 Participants | 41 Participants | 128 Participants |
| Sex/Gender, Customized Male | 28 Participants | 37 Participants | 30 Participants | 95 Participants |
| Sex/Gender, Customized Other | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| SIMP - Agreeableness | 6.6 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 - Conscientiousness | 5.2 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 stability | 5.1 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 - Extraversion | 5.5 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 - Openness | 3.9 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 Participants | 11 Participants | 10 Participants | 31 Participants |
| US region Northeast | 22 Participants | 15 Participants | 14 Participants | 51 Participants |
| US region South | 34 Participants | 34 Participants | 29 Participants | 97 Participants |
| US region West | 14 Participants | 15 Participants | 18 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 75 | 0 / 71 |
| other Total, other adverse events | 0 / 80 | 0 / 75 | 0 / 71 |
| serious Total, serious adverse events | 0 / 80 | 0 / 75 | 0 / 71 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smiling Instead of Smoking | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 12 post-quit (3-month follow-up) | 81.16 units on a scale | Standard Deviation 17.35 |
| Smiling Instead of Smoking | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 6 post-quit | 78.34 units on a scale | Standard Deviation 17.31 |
| Smiling Instead of Smoking | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Baseline | 63.81 units on a scale | Standard Deviation 17.24 |
| Smiling Instead of Smoking | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 2 post-quit | 71.79 units on a scale | Standard Deviation 18.56 |
| Smiling Instead of Smoking | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 24 post-quit (6-month follow-up) | 80.23 units on a scale | Standard Deviation 18.41 |
| Quit Guide | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 6 post-quit | 71.34 units on a scale | Standard Deviation 17.67 |
| Quit Guide | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Baseline | 60.74 units on a scale | Standard Deviation 16.67 |
| Quit Guide | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 2 post-quit | 67.58 units on a scale | Standard Deviation 15.69 |
| Quit Guide | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 12 post-quit (3-month follow-up) | 76.20 units on a scale | Standard Deviation 19.5 |
| Quit Guide | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 24 post-quit (6-month follow-up) | 80.51 units on a scale | Standard Deviation 20.33 |
| Clearing the Air | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 24 post-quit (6-month follow-up) | 74.48 units on a scale | Standard Deviation 23.42 |
| Clearing the Air | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 12 post-quit (3-month follow-up) | 75.22 units on a scale | Standard Deviation 19.12 |
| Clearing the Air | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Baseline | 58.45 units on a scale | Standard Deviation 19.1 |
| Clearing the Air | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 6 post-quit | 68.99 units on a scale | Standard Deviation 19.8 |
| Clearing the Air | End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ) | Week 2 post-quit | 65.40 units on a scale | Standard Deviation 16.59 |
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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Smiling Instead of Smoking | Actual App Usage (SiS and QG Only) | 32.5 number of days of app use |
| Quit Guide | Actual App Usage (SiS and QG Only) | 26.0 number of days of app use |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smiling Instead of Smoking | Appreciation | 108.91 units on a scale | Standard Deviation 13.46 |
| Quit Guide | Appreciation | 106.28 units on a scale | Standard Deviation 15.29 |
| Clearing the Air | Appreciation | 104.98 units on a scale | Standard Deviation 14.26 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smiling Instead of Smoking | App Usability Ratings (SiS and QG Only) | 81.91 units on a scale | Standard Deviation 17.1 |
| Quit Guide | App Usability Ratings (SiS and QG Only) | 79.48 units on a scale | Standard Deviation 15.99 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smiling Instead of Smoking | Likability Rating of the App (SiS and QG Only) | 4.19 units on a scale | Standard Deviation 0.99 |
| Quit Guide | Likability Rating of the App (SiS and QG Only) | 4.08 units on a scale | Standard Deviation 0.87 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smiling Instead of Smoking | Perceived Impact of the Provided Materials on Quitting | 4.13 units on a scale | Standard Deviation 0.72 |
| Quit Guide | Perceived Impact of the Provided Materials on Quitting | 3.98 units on a scale | Standard Deviation 0.55 |
| Clearing the Air | Perceived Impact of the Provided Materials on Quitting | 3.84 units on a scale | Standard Deviation 0.73 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smiling Instead of Smoking | Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only) | 4.25 units on a scale | Standard Deviation 1.04 |
| Quit Guide | Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only) | 4.11 units on a scale | Standard Deviation 0.94 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smiling Instead of Smoking | Satisfaction With Smoking Cessation Support | 26.91 units on a scale | Standard Deviation 5.3 |
| Quit Guide | Satisfaction With Smoking Cessation Support | 26.61 units on a scale | Standard Deviation 4.51 |
| Clearing the Air | Satisfaction With Smoking Cessation Support | 25.65 units on a scale | Standard Deviation 5.8 |
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Smiling Instead of Smoking | Self-reported 30-day Point-prevalence Abstinence | Week 6 post-quit | 32 Participants |
| Smiling Instead of Smoking | Self-reported 30-day Point-prevalence Abstinence | Week 12 post-quit (3-month follow-up) | 36 Participants |
| Smiling Instead of Smoking | Self-reported 30-day Point-prevalence Abstinence | Week 24 post-quit (6-month follow-up) | 38 Participants |
| Smiling Instead of Smoking | Self-reported 30-day Point-prevalence Abstinence | Week 2 post-quit | 9 Participants |
| Quit Guide | Self-reported 30-day Point-prevalence Abstinence | Week 6 post-quit | 23 Participants |
| Quit Guide | Self-reported 30-day Point-prevalence Abstinence | Week 2 post-quit | 3 Participants |
| Quit Guide | Self-reported 30-day Point-prevalence Abstinence | Week 12 post-quit (3-month follow-up) | 31 Participants |
| Quit Guide | Self-reported 30-day Point-prevalence Abstinence | Week 24 post-quit (6-month follow-up) | 32 Participants |
| Clearing the Air | Self-reported 30-day Point-prevalence Abstinence | Week 12 post-quit (3-month follow-up) | 21 Participants |
| Clearing the Air | Self-reported 30-day Point-prevalence Abstinence | Week 24 post-quit (6-month follow-up) | 31 Participants |
| Clearing the Air | Self-reported 30-day Point-prevalence Abstinence | Week 2 post-quit | 9 Participants |
| Clearing the Air | Self-reported 30-day Point-prevalence Abstinence | Week 6 post-quit | 18 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Smiling Instead of Smoking | Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only) | 35.0 average minutes per week |
| Quit Guide | Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only) | 22.5 average minutes per week |
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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Smiling Instead of Smoking | Self-reported Past Week Cigarette Change | Week 12 post-quit (3-month follow-up) | -6.0 Change in weekly cigs since baseline |
| Smiling Instead of Smoking | Self-reported Past Week Cigarette Change | Week 6 post-quit | -5.0 Change in weekly cigs since baseline |
| Smiling Instead of Smoking | Self-reported Past Week Cigarette Change | Week 24 post-quit (6-month follow-up) | -6.0 Change in weekly cigs since baseline |
| Smiling Instead of Smoking | Self-reported Past Week Cigarette Change | Week 2 post-quit | -6.0 Change in weekly cigs since baseline |
| Quit Guide | Self-reported Past Week Cigarette Change | Week 6 post-quit | -6.0 Change in weekly cigs since baseline |
| Quit Guide | Self-reported Past Week Cigarette Change | Week 2 post-quit | -6.0 Change in weekly cigs since baseline |
| Quit Guide | Self-reported Past Week Cigarette Change | Week 12 post-quit (3-month follow-up) | -6.0 Change in weekly cigs since baseline |
| Quit Guide | Self-reported Past Week Cigarette Change | Week 24 post-quit (6-month follow-up) | -6.0 Change in weekly cigs since baseline |
| Clearing the Air | Self-reported Past Week Cigarette Change | Week 12 post-quit (3-month follow-up) | -7.0 Change in weekly cigs since baseline |
| Clearing the Air | Self-reported Past Week Cigarette Change | Week 24 post-quit (6-month follow-up) | -7.0 Change in weekly cigs since baseline |
| Clearing the Air | Self-reported Past Week Cigarette Change | Week 2 post-quit | -7.0 Change in weekly cigs since baseline |
| Clearing the Air | Self-reported Past Week Cigarette Change | Week 6 post-quit | -7.0 Change in weekly cigs since baseline |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Smiling Instead of Smoking | Time Spent Applying Content Brought up by the Apps/Clearing the Air | 30.0 minutes per week |
| Quit Guide | Time Spent Applying Content Brought up by the Apps/Clearing the Air | 25.0 minutes per week |
| Clearing the Air | Time Spent Applying Content Brought up by the Apps/Clearing the Air | 30.0 minutes per week |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smiling Instead of Smoking | Use of Smoking Cessation Strategies | 4.13 units on a scale | Standard Deviation 0.63 |
| Quit Guide | Use of Smoking Cessation Strategies | 3.90 units on a scale | Standard Deviation 0.59 |
| Clearing the Air | Use of Smoking Cessation Strategies | 3.97 units on a scale | Standard Deviation 0.69 |