Clinical trial NCT06678243: Testing the mHealth App Intervention for Nondaily Smokers "SiS4"
Official title: Randomized Clinical Trial to Test the Efficacy of a Smartphone App for Smoking Cessation for Nondaily Smokers (SiS4)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking
smartphone app
smoking cessation
QuitGuide
Smiling instead of Smoking
positive psychology
mHealth
nondaily smoking
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-11-07
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind, remote, randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The goal of this project is to test if a new behavioral treatment for people who smoke nondaily and wish to quit works. The new treatment is a smartphone app that engages users in positive psychology exercises and gives them tested tools for quitting smoking. The positive psychology exercises help users maintain their positive emotions while they quit smoking. This app has been developed with and for people who smoke nondaily through several steps of development.

The main questions it aims to answer are:

* Does the smoking cessation app (SiS4) help people who smoke nondaily quit smoking?
* How do people's attitudes towards smoking, their smoking urges, and their mental well-being shift when using the SiS4 app?

Researchers will compare the new app to an existing app that was developed for people who smoke daily to see if the new app works better to help people who smoke nondaily quit smoking.

Participants will:

1. Use a smartphone app every day for 7 weeks
2. Complete online surveys about their smoking, attitudes about smoking, withdrawal symptoms and smoking urges, app use, and mental well-being at enrollment as well as 2 weeks, 6 weeks, 3 months, 6 months and 12 months after the initially chosen quit date.

If the SiS4 app works well, it would be the first evidence-based quit-smoking treatment for people who smoke nondaily.

Detailed description: The present study is a large-scale (n=1,600) single-blind, remote, parallel, randomized clinical trial (RCT) comparing our app, the SiS app, to the NCI's smartphone app "QuitGuide". The RCT will be conducted entirely remotely, because the app is intended to be accessible to smokers nationally without need for in person contact. All participants will set a targeted smoking cessation quit date and will be instructed to use the provided app for 7 weeks, 1 week prior to and 6 weeks post-quit. Online surveys will be conducted at enrollment and follow-up occurring 2 weeks, 6 weeks, 3 months, 6 months and 12 months after the initially chosen quit date. The primary outcome measure will be 30-day point-prevalence abstinence (PPA) at 6 months post-quit. The investigator team developed the app, "Smiling instead of Smoking (SiS)," specifically for and in collaboration with people who smoke less than daily. This app uses a positive psychology approach, in line with their preference to focus on positive self-identity and wellness.

The investigators have rigorously and iteratively developed and tested this app in a series of small scale prior studies. 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. Study 3 (NCT04672239) demonstrated the app's ability to engage nondaily smokers and showed proof-of-concept efficacy in a small, randomized trial, where participants using the SiS app had significantly higher self-efficacy, lower craving, and higher positive affect at the end of treatment, compared to controls.

In this large-scale efficacy trial, the primary outcome measure will be 30-day point-prevalence abstinence (PPA) at 6-month post quit. The aims of the study are:

Aim 1: Test the effectiveness of the SiS app to improve smoking cessation outcomes

1. H1: 30-day PPA six months post quit will be higher for SiS compared to QuitGuide participants.
2. H2: SiS participants will have higher 30-day PPA at end of treatment and 12 months post quit.

Aim 2: Examine mechanisms and moderators of change

1. Using mediation modeling, the investigators will test if theorized mechanisms of change (i.e., self-efficacy, positive affect, or craving) account for observed effects on 30-day PPA six months post quit.
2. (Exploratory aim:) Using moderated mediation models, the investigators will examine if socioeconomic status, race, and/or the presence of mental health conditions moderate the effectiveness of SiS or moderate the mediation effects outlined in aim 2a.

Exploratory Aim 3: Explore app usage patterns and their relationship to smoking cessation

1. The investigators will identify patterns of overall app use, as identified by group-based trajectory modeling.
2. The investigators will conduct a feature-level analysis of the apps (i.e., which features got used how often).
3. The investigators will test if patterns of app use and/or feature use predict 30-day PPA six months post-quit.

If found to be efficacious, this study would provide the first evidence of an efficacious treatment (the SiS app) for people who smoke less than daily, for whom currently no treatment guidelines exist.

Eligibility criteria: * 18 years of age or older
* Sufficiently fluent in English to read and comprehend intervention and assessment materials
* Owns a smartphone (Android or iOS only)
* Currently smokes less than daily but at least weekly
* Has smoked 100+ cigarettes lifetime
* Has current intention to quit smoking
* Currently resides in the US
* Can use online survey technology to complete surveys
* Can download, install and use a smartphone app

Primary outcomes:
measure: Self-reported 30-day point-prevalence abstinence (PPA) from smoking
timeFrame: Baseline, 2, 6, 12, 24, and 52 weeks
Secondary outcomes:
measure: Self-reported 7-day point-prevalence abstinence (PPA) from smoking
timeFrame: Baseline, 2, 6, 12, 24, and 52 weeks
measure: Change in cigarettes smoked
timeFrame: 2, 6, 12, 24, and 52 week after baseline
measure: Smoking self-efficacy
timeFrame: Baseline, 2, 6, 12, 24, and 52 weeks
measure: Positive affect
timeFrame: Baseline, 2, 6, 12, 24, and 52 weeks
measure: Negative affect
timeFrame: Baseline, week 2, 6, 12, 24, and 52
measure: Mood and Physical Symptoms Scale (MPSS) (modified)
timeFrame: Baseline, 2, 6, 12, 24, and 52 weeks
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: Hoeppner BB, Kelly JF, Urbanoski KA, Slaymaker V. Comparative utility of a single-item versus multiple-item measure of self-efficacy in predicting relapse among young adults. J Subst Abuse Treat. 2011 Oct;41(3):305-12. doi: 10.1016/j.jsat.2011.04.005. Epub 2011 Jun 22.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. doi: 10.1007/s00213-004-1923-6. Epub 2004 Jun 4.