Testing the mHealth App Intervention for Nondaily Smokers "SiS4"

NCT06678243 | Recruiting

• 2 other identifiers: 24-5011R01CA282223
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

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:
• Use a smartphone app every day for 7 weeks
• 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.

Conditions

Smoking Cessation

Keywords

smoking; smartphone app; smoking cessation; QuitGuide; Smiling instead of Smoking; positive psychology; mHealth; nondaily smoking

Outcome Measures

Primary Outcomes (1)

• Self-reported 30-day point-prevalence abstinence (PPA) from smoking

  The 30-day point prevalence abstinence (PPA) is a self-reported measure recorded at 6 months post-quit. In each online survey participant will be asked to report, "During the past 30 days, on how many days did you smoke". If a participant does not report abstinence, they will be asked to indicate how many cigarettes they smoked per day on the days they smoked and whether they are seriously thinking of quitting smoking. The investigators will also include the question, "have you been abstinent during the past 30 days?" (yes/no). In order to get to this question, participants will answer have to answer prior questions as, " I do not smoke at all", and "yes", they have been abstinent during the past 7 days. The investigators will code a binary indicator for self-reported 30-day point prevalence abstinence (yes/ no).

  Baseline, 2, 6, 12, 24, and 52 weeks

Secondary Outcomes (6)

• Self-reported 7-day point-prevalence abstinence (PPA) from smoking

  Baseline, 2, 6, 12, 24, and 52 weeks

• Change in cigarettes smoked

  2, 6, 12, 24, and 52 week after baseline

• Smoking self-efficacy

  Baseline, 2, 6, 12, 24, and 52 weeks

• Positive affect

  Baseline, 2, 6, 12, 24, and 52 weeks

• Negative affect

  Baseline, week 2, 6, 12, 24, and 52

Study Arms (2)

Smiling instead of Smoking

EXPERIMENTAL

Participants will be onboarded to the smartphone app "Smiling instead of Smoking" (SiS4) and will be asked to use it for 7 weeks while they quit smoking.

Behavioral: Smiling instead of Smoking

QuitGuide

ACTIVE COMPARATOR

Participants will be onboarded to the smartphone app "QuitGuide" (QG) which will be 're-branded', so that the name "Smiling instead of Smoking" will appear in the banner of the app instead of "QuitGuide", and will be asked to use it for 7 weeks while they quit smoking.

Behavioral: QuitGuide

Interventions

Smiling instead of Smoking BEHAVIORAL

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 process of smoking cessation; and (2) traditional behavioral smoking cessation content to guide their quit process based on US Clinical Practice Guidelines.

Also known as: SiS4

Smiling instead of Smoking

QuitGuide BEHAVIORAL

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 cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).

Also known as: QG

QuitGuide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Bettina Hoeppner, Ph.D., M.S.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bettina Hoeppner, Ph.D., M.S.

CONTACT

617-643-1988; bhoeppner@mgh.harvard.edu

Susanne Hoeppner, PhD, MApStat

CONTACT

617-643-9934; shoeppner@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: single-blind, remote, randomized clinical trial

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The investigators will provide de-identified data from this project to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome papers).
• Access Criteria: Data sharing will be contingent on meeting all institutional regulations for data use agreements and on receiving evidence of the recipient's institution's IRB approval for planned analyses of the data. Interested parties requesting data will receive the requested data needed to execute their analysis plan in accordance with these approvals. The IPD will be provided in digital format with clear labels for all variables, will be de-identified before it is shared, and will be released directly by the investigators to the recipients with secure data tranfer. Regarding supporting information, the final version of the study protocol (including the statistical analysis plan (SAP)) and the final version of the Informed Consent Form (ICF) will be made publicly available in this clinicaltrials.gov record. Additional supporting information, including analytic code, will be made available upon a specific request to the investigative team.

Locations

US (1)