Testing the mHealth App Intervention for Nondaily Smokers "SiS4"

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06678243
Status
Recruiting
Apply to this trial

Conditions

  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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).

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
Apr 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
1,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Bettina B Hoeppner
[email protected]
6176431988

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies