Clinical trial NCT04672239: A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)
Official title: A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nondaily Smoking
Keywords: nondaily smoking
smartphone app
smoking cessation
QuitGuide
Smiling instead of Smoking
SiS
positive psychology
mHealth
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-group proof-of-concept RCT
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
timeFrame: 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).
Secondary outcomes:
measure: Self-reported 30-day Point-prevalence Abstinence
timeFrame: 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).
measure: Self-reported Past Week Cigarette Change
timeFrame: 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).
measure: Satisfaction With Smoking Cessation Support
timeFrame: 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).
measure: Time Spent Applying Content Brought up by the Apps/"Clearing the Air"
timeFrame: 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).
measure: Use of Smoking Cessation Strategies
timeFrame: 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).
measure: Perceived Impact of the Provided Materials on Quitting
timeFrame: 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).
measure: Appreciation
timeFrame: 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).
measure: Actual App Usage (SiS and QG Only)
timeFrame: 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).
measure: Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)
timeFrame: 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).
measure: Likability Rating of the App (SiS and QG Only)
timeFrame: 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).
measure: Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only)
timeFrame: 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).
measure: App Usability Ratings (SiS and QG Only)
timeFrame: 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).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Bettina Hoeppner, Ph.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. doi: 10.1046/j.1360-0443.2000.9569017.x.
citation: Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
citation: Adler MG, Fagley NS. Appreciation: individual differences in finding value and meaning as a unique predictor of subjective well-being. J Pers. 2005 Feb;73(1):79-114. doi: 10.1111/j.1467-6494.2004.00305.x.
citation: Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996;189(194):4-7.