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)

Overview

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.

Interventions

• Behavioral Smiling instead of Smoking
  Participants randomized to the treatment condition will use the "Smiling instead of Smoking" (SiS) smartphone app. This app delivers and guides participants through two types of content to help them during their quit attempt: (1) positive psychology content (i.e., happiness habit-building exercises, happiness boost activity, and science-based information on the relevance of positive psychology activities) designed to help nondaily smokers maintain positive affect while they go through the proces
• Behavioral QuitGuide
  Participants randomized to the control condition will use the National Cancer Institute (NCI)'s "QuitGuide" (QG) smartphone app. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravi

Primary outcome measures

• Self-reported 30-day point-prevalence abstinence (PPA) from smoking [Time frame: Baseline, 2, 6, 12, 24, and 52 weeks]

Secondary outcome measures (6)

• Self-reported 7-day point-prevalence abstinence (PPA) from smoking [Time frame: Baseline, 2, 6, 12, 24, and 52 weeks]
• Change in cigarettes smoked [Time frame: 2, 6, 12, 24, and 52 week after baseline]
• Smoking self-efficacy [Time frame: Baseline, 2, 6, 12, 24, and 52 weeks]
• Positive affect [Time frame: Baseline, 2, 6, 12, 24, and 52 weeks]
• Negative affect [Time frame: Baseline, week 2, 6, 12, 24, and 52]
• Mood and Physical Symptoms Scale (MPSS) (modified) [Time frame: Baseline, 2, 6, 12, 24, and 52 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Massachusetts General Hospital — Boston

Publications

• 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. PMID 21700411
• 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. PMID 3397865
• 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. PMID 15179542

Identifiers

NCT: NCT06678243 · 24-501 · 1R01CA282223

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗