18 and older, any sex, with Smoking Cessation or Smoking, Tobacco. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Ease-of-use and Helpfulness of the AppPrimary· 6 weeks after chosen smoking cessation date
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 indica
Ease of use: Completing the positive psychology exercises every day.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.39
± 0.89
Ease of use: Specifically, completing the specific exercise called 3 Good Things.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.36
± 0.89
Ease of use: Specifically, completing the specific exercise called Savoring.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.42
± 0.79
Ease of use: Specifically, completing the specific exercise called Experiencing Kindness.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.39
± 0.90
Ease of use: Specifically, completing the specific exercise called Reliving Happy Moments.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.54
± 0.77
Ease of use: Specifically, completing the specific exercise called Rose, Thorn and Bud.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.40
± 0.83
Ease of use: Viewing your past happiness exercises in the Happiness Log.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.64
± 0.67
Ease of use: Viewing Owl Wisdoms within the Treasure Chest menu.
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.57
± 0.65
Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)Secondary· Baseline, 2-weeks, and 6-weeks post-quit
This 10-item scale assesses overall nicotine dependence, craving, and smoking withdrawal symptoms. Items were rated on a 7-point Likert-scale ranging from 1=Strongly disagree to 7=Strongly agree. We presented mean instead of total scores for ease in interpretation, so that scale scores can range from 1.0 to 7.0, with higher scores indicating greater smoking urges.
Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.66
± 1.36
Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.50
± 1.38
Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.18
± 1.57
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges MeasureSecondary· Baseline, 2-weeks, and 6-weeks post-quit
Single-item measure: "Right now, how strong is your desire/urge to smoke?". This single-item measure was rated on a scale of "0, not at all strong" to "100, extremely strong", so that higher scores indicate stronger smoking urges.
Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
50.87
± 27.03
Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
31.27
± 29.31
Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
26.12
± 30.90
Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)Secondary· Baseline, 2-weeks, and 6-weeks post-quit
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, deter
PANAS - Positive Affect - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.39
± 0.82
PANAS - Positive Affect - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.47
± 0.77
PANAS - Positive Affect - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.59
± 0.90
PANAS - Negative Affect - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.32
± 1.02
PANAS - Negative Affect - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.13
± 0.79
PANAS - Negative Affect - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.18
± 1.10
Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)Secondary· Baseline, 2-weeks, and 6-weeks post-quit
This 4-item scale assesses global subjective happiness. Each question is rated on a Likert-scale of 1-7. Scale scores were reported as mean scores in this study, with higher scores indicating higher subjective happiness.
Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4.77
± 1.39
Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4.81
± 1.38
Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4.94
± 1.42
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness MeasuresSecondary· Baseline, 2-weeks, and 6-weeks post-quit
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.
Happiness Past Week - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
67.74
± 21.50
Happiness Past Week - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
67.75
± 21.88
Happiness Past Week - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
69.69
± 23.91
Happiness Right Now - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
70.04
± 20.38
Happiness Right Now - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
68.55
± 25.34
Happiness Right Now - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
70.03
± 24.93
Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)Secondary· Baseline, 2-weeks, and 6-weeks post-quit
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.
SEQ Internal Cues - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
53.44
± 22.04
SEQ Internal Cues - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
60.15
± 23.33
SEQ Internal Cues - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
66.98
± 29.09
SEQ External Cues - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
58.89
± 21.10
SEQ External Cues - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
64.75
± 23.31
SEQ External Cues - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
70.64
± 26.92
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy MeasureSecondary· Baseline, 2-weeks, and 6-weeks post-quit
The single-item self-efficacy measure asked: "How CONFIDENT are you that you will be able to quit smoking/stay quit?" This item was measured on a slider scale ranging from 0="not at all" to 100="extremely confident", so that higher scores indicate greater confidence in the ability to quit smoking or stay quit.
Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
75.71
± 20.05
2-week
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
76.91
± 19.42
6-week
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
81.22
± 22.16
Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit MeasureSecondary· Baseline, 2-weeks, and 6-weeks post-quit
The single-item self-efficacy measure asked: "How MOTIVATED are you to quit smoking/ stay quit?" This item was measured on a slider scale ranging from 0="not at all" to 100="extremely motivated", where higher scores indicate a greater motivation to quit smoking or stay quit.
Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
88.04
± 14.57
2-week
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
83.74
± 18.36
6-week
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
81.73
± 22.61
Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)Secondary· Baseline, 2-weeks, and 6-weeks post-quit
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.
ATS-18 Adverse effects of smoking - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4.42
± 0.54
ATS-18 Adverse effects of smoking - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4.46
± 0.55
ATS-18 Adverse effects of smoking - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4.44
± 0.83
ATS-18 Psychoactive benefits of smoking - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.97
± 0.73
ATS-18 Psychoactive benefits of smoking - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.59
± 1.01
ATS-18 Psychoactive benefits of smoking - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.17
± 1.29
ATS-18 Pleasure of smoking - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.27
± 1.00
ATS-18 Pleasure of smoking - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
2.95
± 1.23
Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)Secondary· Baseline, 2-weeks, and 6-weeks post-quit
The Commitment to Quitting Smoking Scale (CQSS) asks participants to rate their level of agreement (Likert scale, 1="strongly disagree" to 5="strongly agree") on 8-items assessing motivation to quit smoking (e.g., I'm not going to let anything get in the way of my quitting smoking).
Scale scores are reported as the average of all items, where higher scores indicate a greater commitment to quitting smoking.
Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4.08
± 0.67
Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
3.98
± 0.76
Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
4
± 0.99
Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)Secondary· Baseline, 2-weeks, and 6-weeks post-quit
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).
DBI positive expectancies - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
56.59
± 19.89
DBI positive expectancies - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
45.01
± 23.96
DBI positive expectancies - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
35.97
± 29.49
DBI negative expectancies - Baseline
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
68.61
± 26.24
DBI negative expectancies - Week 2
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
66.44
± 26.25
DBI negative expectancies - Week 6
Group
Value
95% CI
Smiling Instead of Smoking (SiS) App Version 2
66.17
± 28.93
Sponsor's own description
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)
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 26 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03951766.