SiS4 App for Smoking Cessation

Overseen By Susanne Hoeppner, PhD, MApStat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Under 18, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 7 weeks

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app designed to help occasional smokers quit. The app, called the SiS4 mHealth App Intervention, uses positive psychology exercises to boost mood and offers tools for quitting. The trial compares this new app with another app intended for daily smokers to determine which is more effective for nondaily smokers. It suits those who smoke less than daily but at least weekly and want to quit. Participants will use the app daily for seven weeks and complete several surveys over the course of a year. As an unphased trial, this study allows participants to contribute to innovative research that could shape future smoking cessation tools.

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 prior data suggests that the SiS4 app is safe for smoking cessation?

Research has shown that the SiS4 app, designed to help occasional smokers quit, has been tested in earlier studies. These studies evaluated user experiences and the app's effectiveness in aiding smoking cessation. So far, users have reported no serious side effects or major issues. Feedback has improved the app's usability and effectiveness.

As a smartphone tool rather than a medication, the SiS4 app does not cause the physical side effects associated with drugs. Instead, it focuses on user management and its impact on changing smoking habits. Overall, this makes it a low-risk option for those seeking to quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SiS4 app for smoking cessation because it offers a fresh, digital approach to help nondaily smokers quit. Unlike traditional methods like nicotine replacement therapy or counseling, SiS4 leverages mobile technology to provide support and engagement directly through a smartphone app. This app focuses on positive reinforcement, encouraging users to "smile instead of smoke," which could make the quitting process more engaging and personalized. Additionally, the app's 7-week structured program aims to support users consistently, providing an innovative alternative to existing smoking cessation options.

What evidence suggests that the SiS4 app is effective for smoking cessation?

This trial will compare the effectiveness of two smartphone apps for smoking cessation. Studies have shown that the SiS4 app, one of the apps tested in this trial, may be effective for occasional smokers. Research indicates that the app uses exercises from positive psychology to help users maintain a positive mindset while quitting. Early findings suggest these exercises can boost users' confidence in their ability to quit smoking. Previous research has also shown that people using the SiS4 app are more likely to stop smoking. Although the SiS4 app is still under evaluation in this trial, these early results are promising for those trying to quit smoking. ^{1 3 5 6 7}

Who Is on the Research Team?

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

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Smiling instead of Smoking Experimental Treatment 1 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: QuitGuide Active Control 1 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.

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+

Published Research Related to This Trial

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation Apps: A Systematic Review of Format, Outcomes, and Features. Barroso-Hurtado, M., Suárez-Castro, D., Martínez-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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-tabac smartphone application for smoking cessation: a randomized controlled trial. Etter, JF., Khazaal, Y.[2023]

The Stop-Tabac app, designed for smoking cessation, is being tested in a large randomized trial with 5200 participants to assess its effectiveness over 6 months, providing personalized support and feedback to users.

This study aims to address the lack of evidence on the impact of health apps for smoking cessation, potentially improving access to support and compliance with nicotine therapy for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. Etter, JF., Khazaal, Y.[2021]

This pilot study aims to evaluate the effectiveness of a commercially available smartphone app for tobacco cessation among young adults aged 18-30 who smoke more than 5 cigarettes a day, comparing it to usual care in a hospital setting.

The study will focus on feasibility metrics such as recruitment, retention, and adherence to the app, which will inform future larger trials on the effectiveness and cost-effectiveness of mobile interventions for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial. Chu, KH., Escobar-Viera, CG., Matheny, SJ., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9975937/

Testing the Outcomes of a Smoking Cessation Smartphone ... This study is designed to test whether the prescribed use of the SiS app results in greater self-efficacy to abstain from smoking in nondaily ...

2. massgeneral.trialstoday.org massgeneral.trialstoday.org/trial/NCT06678243

Testing the mHealth App Intervention for Nondaily Smokers ... The new treatment is a smartphone app that engages users in positive psychology exercises and gives them tested tools for quitting smoking.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03951766

Version 2 of the Smoking Cessation Smartphone App ... The overall goal of this pilot study is to solicit feedback from nondaily smokers looking for smoking cessation support online (n=90) about Version 2 of a ...

4. trialx.com trialx.com/clinical-trials/listings/313953/testing-the-mhealth-app-intervention-for-nondaily-smokers-sis4/

Testing the mHealth App Intervention for Nondaily Smokers ... The primary outcome measure will be 30-day point-prevalence abstinence (PPA) at 6 months post-quit. The investigator team developed the app, " ...

5. mhealth.jmir.org mhealth.jmir.org/2025/1/e53971

Smoking Cessation Smartphone App for Nondaily Smoking ... This study aimed to conduct an unblinded randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39814363/

Smoking Cessation Smartphone App for Nondaily ... This study aimed to conduct an unblinded randomized controlled trial to evaluate proof-of-concept markers of the Smiling instead of Smoking (SiS) app.

7. withpower.com withpower.com/trial/phase-smoking-cessation-11-2024-e66cf

SiS4 App for Smoking Cessation 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 ...