Recruiting

SiS4

Sponsor:

Massachusetts General Hospital

Code:

NCT06678243

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smiling instead of Smoking

QuitGuide

Study Details

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.

Conditions

Smoking Cessation

Study ID

NCT06678243

Start date

Dec 6, 2024

Status verified date

Apr, 2025

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

1600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Smiling instead of Smoking

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.

active comparator: QuitGuide

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.

Interventions

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

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 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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

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

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

Susanne Hoeppner, PhD, MApStat

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Bettina B Hoeppner

6176431988BHOEPPNER@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 11, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-06-11.