18 and older, any sex, with Nondaily Smoking. 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.
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)Primary· 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.
Baseline
Group
Value
95% CI
Smiling Instead of Smoking
63.81
± 17.24
Quit Guide
60.74
± 16.67
Clearing the Air
58.45
± 19.10
Week 2 post-quit
Group
Value
95% CI
Smiling Instead of Smoking
71.79
± 18.56
Quit Guide
67.58
± 15.69
Clearing the Air
65.40
± 16.59
Week 6 post-quit
Group
Value
95% CI
Smiling Instead of Smoking
78.34
± 17.31
Quit Guide
71.34
± 17.67
Clearing the Air
68.99
± 19.80
Week 12 post-quit (3-month follow-up)
Group
Value
95% CI
Smiling Instead of Smoking
81.16
± 17.35
Quit Guide
76.20
± 19.50
Clearing the Air
75.22
± 19.12
Week 24 post-quit (6-month follow-up)
Group
Value
95% CI
Smiling Instead of Smoking
80.23
± 18.41
Quit Guide
80.51
± 20.33
Clearing the Air
74.48
± 23.42
Self-reported 30-day Point-prevalence AbstinenceSecondary· 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 thos
Week 2 post-quit
Group
Value
95% CI
SiS App Treatment
9
QG App Treatment
3
CTA Pamphlet
9
Week 6 post-quit
Group
Value
95% CI
SiS App Treatment
32
QG App Treatment
23
CTA Pamphlet
18
Week 12 post-quit (3-month follow-up)
Group
Value
95% CI
SiS App Treatment
36
QG App Treatment
31
CTA Pamphlet
21
Week 24 post-quit (6-month follow-up)
Group
Value
95% CI
SiS App Treatment
38
QG App Treatment
32
CTA Pamphlet
31
Self-reported Past Week Cigarette ChangeSecondary· 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.
Week 2 post-quit
Group
Value
95% CI
SiS App Treatment
-6.0
-12.0 – -2.5
QG App Treatment
-6.0
-11.0 – -3.0
CTA Pamphlet
-7.0
-11.0 – -3.0
Week 6 post-quit
Group
Value
95% CI
SiS App Treatment
-5.0
-12.0 – -1.0
QG App Treatment
-6.0
-11.0 – -3.0
CTA Pamphlet
-7.0
-13.0 – -4.0
Week 12 post-quit (3-month follow-up)
Group
Value
95% CI
SiS App Treatment
-6.0
-12.0 – -1.5
QG App Treatment
-6.0
-11.0 – -2.0
CTA Pamphlet
-7.0
-13.5 – -3.0
Week 24 post-quit (6-month follow-up)
Group
Value
95% CI
SiS App Treatment
-6.0
-9.5 – 0.0
QG App Treatment
-6.0
-10.0 – -2.0
CTA Pamphlet
-7.0
-12.5 – -2.0
Satisfaction With Smoking Cessation SupportSecondary· 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.
Group
Value
95% CI
SiS App Treatment
26.91
± 5.30
QG App Treatment
26.61
± 4.51
Clearing the Air Pamphlet
25.65
± 5.80
Time Spent Applying Content Brought up by the Apps/"Clearing the Air"Secondary· 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"?" \[in minutes\].
Group
Value
95% CI
SiS App Treatment
30.0
29.0 – 70.0
QG App Treatment
25.0
10.0 – 60.0
CTA Pamphlet
30.0
10.0 – 60.0
Use of Smoking Cessation StrategiesSecondary· 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
Group
Value
95% CI
SiS App Treatment
4.13
± 0.63
QG App Treatment
3.90
± 0.59
CTA Pamphlet
3.97
± 0.69
Perceived Impact of the Provided Materials on QuittingSecondary· 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 ran
Group
Value
95% CI
SiS App Treatment
4.13
± 0.72
QG App Treatment
3.98
± 0.55
CTA Pamphlet
3.84
± 0.73
AppreciationSecondary· 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
Group
Value
95% CI
SiS App Treatment
108.91
± 13.46
QG App Treatment
106.28
± 15.29
CTA Pamphlet
104.98
± 14.26
Actual App Usage (SiS and QG Only)Secondary· 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.
Group
Value
95% CI
SiS App Treatment
32.5
11.0 – 39.5
QG App Treatment
26.0
11.0 – 38.0
Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)Secondary· 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.
Group
Value
95% CI
SiS App Treatment
35.0
21.0 – 70.0
QG App Treatment
22.5
14.0 – 60.0
Likability Rating of the App (SiS and QG Only)Secondary· 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).
Group
Value
95% CI
SiS App Treatment
4.19
± 0.99
QG App Treatment
4.08
± 0.87
Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only)Secondary· 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).
Group
Value
95% CI
SiS App Treatment
4.25
± 1.04
QG App Treatment
4.11
± 0.94
Sponsor's own description
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
· withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg
· NA
· not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
· NA
· not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries
· NA
· not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
· EARLY_PHASE1
· not yet recruiting
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: 19 September 2024
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/NCT04672239.