1600 Participants Needed

SiS4 App for Smoking Cessation

BH
SH
Overseen BySusanne Hoeppner, PhD, MApStat
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a smartphone app to help quit smoking.

What data supports the effectiveness of the SiS4 App treatment for smoking cessation?

Research shows that smoking cessation apps, like the SiS4 App, can be promising tools for helping people quit smoking. These apps are widely available and attractive, making them a great opportunity to reach many people, although more high-quality research is needed to confirm their effectiveness.12345

Is the SiS4 App for Smoking Cessation safe for humans?

The available research on smoking cessation apps, including those similar to the SiS4 App, does not report any specific safety concerns for users. These apps are generally considered safe as they primarily provide support and guidance for quitting smoking.12356

How is the SiS4 App treatment for smoking cessation different from other treatments?

The SiS4 App is unique because it is a mobile health (mHealth) app specifically designed for nondaily smokers, offering a convenient and accessible way to quit smoking without the need for face-to-face interventions. Unlike traditional methods that may require in-person support or nicotine medications, this app provides self-tracking and personalized quit plans directly on a smartphone, making it easier for users to engage with the treatment at their own pace.14578

Research Team

BH

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

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for nondaily smokers in the US who want to quit, can read English, have smoked over 100 cigarettes in their lifetime, and own a smartphone. They must be at least 18 years old and able to use online surveys and apps.

Inclusion Criteria

I can read and understand English well.
I own a smartphone that is either Android or iOS.
I currently live in the US.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SiS4 app daily for 7 weeks, including 1 week prior to and 6 weeks post-quit date

7 weeks
Remote participation

Follow-up

Participants complete online surveys to monitor smoking status, attitudes, and well-being at multiple intervals post-quit

12 months
Online surveys at 2, 6, 12, 24, and 52 weeks

Treatment Details

Interventions

  • mHealth App Intervention for Nondaily Smokers 'SiS4'
Trial Overview Researchers are testing a new smartphone app called SiS4 designed for nondaily smokers trying to quit. It uses positive psychology exercises alongside quitting tools. The study compares it with an existing app made for daily smokers to see which helps more.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Smiling instead of SmokingExperimental Treatment1 Intervention
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.
Group II: QuitGuideActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Mobile health (mHealth) apps for smoking cessation, both as standalone general apps (GSC-Apps) and in combination with face-to-face interventions (FFSC-Apps), show promise in improving smoking cessation outcomes, with some studies indicating significant benefits from their use.
Despite the potential of these apps to reach a wide audience due to their accessibility, further high-quality research is necessary to fully understand their effectiveness and optimize their features for better results.
Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features.Barroso-Hurtado, M., Suรกrez-Castro, D., Martรญnez-Vispo, C., et al.[2021]
A study involving 181 participants found that most users rated the smoking cessation app QuitPal-m as very helpful, but daily usage declined over time, indicating a need for ongoing support to maintain engagement.
The effectiveness of the app was enhanced by supportive accountability from cessation counselors, particularly for smokers with low motivation to quit, highlighting the importance of addressing both personal barriers and technical issues to improve app usage.
Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study.Lepore, SJ., Collins, BN., Killam, HW., et al.[2023]
The Stop-tabac smartphone application did not significantly increase smoking cessation rates after 6 months compared to a control app, with cessation rates of 9.9% in the Stop-tabac group versus 10.3% in the control group.
However, users of the Stop-tabac app reported a higher usage of nicotine medications (38% vs. 30%) and a greater percentage (26%) felt the app helped them significantly in quitting smoking compared to only 8% in the control group.
The Stop-tabac smartphone application for smoking cessation: a randomized controlled trial.Etter, JF., Khazaal, Y.[2023]

References

Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features. [2021]
Supportive Accountability and Mobile App Use in a Tobacco Control Intervention Targeting Low-Income Minority Mothers Who Smoke: Observational Study. [2023]
A mobile app to aid smoking cessation: preliminary evaluation of SmokeFree28. [2022]
The Stop-tabac smartphone application for smoking cessation: a randomized controlled trial. [2023]
What Do People Want in a Smoking Cessation App? An Analysis of User Reviews and App Quality. [2022]
Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial. [2020]
The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. [2021]
Smoking Cessation: Services and Applications for Mobile Devices. [2018]
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