Mobile Apps for Smoking Cessation

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Suicidal ideation, Major depressive episode, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different mobile apps designed to help people quit smoking. Breathe2Relax focuses on relaxation techniques, while Free4Good aims to boost positive emotions and thoughts. The researchers aim to determine which app more effectively supports individuals actively trying to quit. This trial suits MD Anderson patients who have smoked for at least a year, use an iPhone, and are ready to set a quit date soon. Participants will also receive standard tobacco cessation treatment from the Tobacco Treatment Program. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research in smoking cessation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, any medication that could affect your safety or treatment might be reviewed by the study team.

What prior data suggests that these mobile apps are safe for smoking cessation?

A previous study found the Breathe2Relax app to be a helpful tool for managing stress, teaching techniques like deep breathing. No reports of serious side effects suggest it is safe to use.

Research has shown that smartphone apps can help people quit smoking. The Free4Good app aims to increase positive feelings and behaviors, potentially assisting in smoking cessation. Participant trials indicate it is well-tolerated, with no major side effects reported.

Both apps appear safe based on available research, with no significant adverse events noted. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile apps Breathe2Relax and Free4Good for smoking cessation because they offer innovative approaches that differ from traditional methods like nicotine replacement therapies and prescription medications. Breathe2Relax is unique as it helps users develop relaxation skills to manage stress, a major trigger for smoking. On the other hand, Free4Good focuses on boosting positive feelings, behaviors, and thoughts, addressing the psychological aspects of smoking addiction. These digital interventions provide personalized, accessible support directly through a smartphone, making them convenient and easily integrated into daily life.

What evidence suggests that these mobile apps are effective for smoking cessation?

Research has shown that smartphone apps can help people quit smoking. In this trial, participants will use different apps in separate groups. For example, studies have found that the Breathe2Relax app, used by one group, can improve mood, which might aid in quitting. Meanwhile, the Free4Good app, used by another group, aims to boost positive feelings and actions. Reviews of similar apps suggest they can increase the chances of quitting and help people remain smoke-free longer. Overall, both types of apps may support quitting smoking by enhancing mood and encouraging positive changes. ^{1 4 6 7 8}

Who Is on the Research Team?

Jennifer A. Minnix

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult smokers aged 18-65 who are patients at MD Anderson, have been smoking daily for at least a year, and own an iPhone with regular app usage. They must be willing to set a quit date within the next month and not be receiving other cessation treatments or suffering from severe depression or conditions that could risk their safety.

Inclusion Criteria

Current smoker (i.e., at least 1 cigarette or e-cig per day)

Currently own an iOS mobile phone (iPhone) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app

I can speak and understand English well.

Exclusion Criteria

Endorsing current suicidal ideation or intent

Meeting criteria for a current Major Depressive Episode measured by the PHQ-9

Subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax) while receiving tobacco cessation treatment

8 weeks

Follow-up

Participants are monitored for adherence, acceptability, user satisfaction, and preliminary efficacy of the mobile apps

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breathe2Relax mobile app
• Free4Good mobile app

Trial Overview The study tests two smartphone apps' effectiveness in aiding smoking cessation among participants already enrolled in a Tobacco Treatment Program. One group will use the Free4Good app focusing on positive psychology, while the control group will use Breathe2Relax, an app for breathing relaxation.

How Is the Trial Designed?

Group I: Group 2 smartphone applications Experimental Treatment 1 Intervention

app is designed to help you increase your positive feelings, behaviors, and thoughts.

Group II: Group 1 smartphone applications Experimental Treatment 1 Intervention

app is designed to help you learn relaxation skills

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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]

Out of 112 smoking cessation apps reviewed, only six were identified as high-quality and partially adhered to Australian smoking cessation treatment guidelines, indicating a lack of robust options for users.

Only two of the high-quality apps had their efficacy evaluated, highlighting the need for more research to assess the effectiveness of smoking cessation apps and ensure they provide reliable support for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free smoking cessation mobile apps available in Australia: a quality review and content analysis. Thornton, L., Quinn, C., Birrell, L., et al.[2022]

In a study involving 28,112 smokers, the full version of the Smoke Free app significantly increased self-reported smoking abstinence rates at 3 months compared to the reduced version, with odds ratios indicating a nearly doubled likelihood of quitting.

The follow-up rates were low (8.5% for the full version and 6.5% for the reduced version), but the results consistently showed that the full version, which included additional features like daily missions and progress updates, was more effective in helping users quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative effectiveness of a full versus reduced version of the 'Smoke Free' mobile application for smoking cessation: a randomised controlled trial. Crane, D., Ubhi, HK., Brown, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03519451

Use of a Smartphone Mobile Application (App) to Enhance ... Study Overview. Brief Summary. This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers.

2. withpower.com withpower.com/trial/phase-3-2019-0b915

Mobile Apps for Smoking Cessation · Info for Participants In a study involving 28,112 smokers, the full version of the Smoke Free app significantly increased self-reported smoking abstinence rates at 3 months compared ...

3. clinicaltrial.be clinicaltrial.be/en/details/7341?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Use of a Smartphone Mobile Application (App) to Enhance ... Evidence of improved mood in KickAsh and Breathe2Relax groups. Evidence of improved mood determined by questionnaires, phone calls, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9437788/

Smoking Cessation Smartphone App Use Over Time The data retention rate was 88% (1886/2133) and differed slightly between arms (90% in QuitGuide vs 87% in iCanQuit; P=.01). Interventions.

5. researchgate.net researchgate.net/publication/328816717_Smartphone_Apps_for_Psychological_Health_A_Brief_State_of_the_Science_Review

Smartphone Apps for Psychological Health: A Brief State of ... We describe the variety of psychological health app uses from self-management, skills training, and supportive care to symptom tracking and data ...

6. mobile.health.mil mobile.health.mil/Apps/PWA-Apps/Breathe-2-Relax

Breathe2Relax - mobile apps - Health.mil Breathe2Relax is a portable stress management tool which provides detailed information on the effects of stress on the body and instructions and practice ...

7. play.google.com play.google.com/store/apps/details?id=mil.dha.breathe2relax&hl=en_US

Breathe2Relax - Apps on Google Play Breathe2Relax is a portable stress management tool which provides detailed information on the effects of stress on the body and instructions and practice ...

8. health.mil health.mil/News/Articles/2024/10/24/Military-Health-System-Using-Mobile-Apps-for-Warfighter-Readiness

Military Health System Using Mobile Apps for Warfighter ... Breathe2RelaxBreathe2Relax App: A portable stress management tool which provides detailed information on the effects of stress on the body.