Smoking Cessation App for Mental Health Disorders

(MTQT Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Roger Vilardaga, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Substance use, Acute psychosis, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial will test a new smartphone app called Quit on the Go, designed to help people with serious mental illness quit smoking. The study will compare this app to traditional methods, with both groups also using nicotine patches and gum. The goal is to see if the app helps more people quit smoking and if it is cost-effective.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be currently receiving psychiatric treatment and intend to continue it during the study.

What data supports the idea that Smoking Cessation App for Mental Health Disorders is an effective treatment?

The available research shows that smoking cessation apps, like the Learn to Quit App, are promising tools for helping people with serious mental illness (SMI) quit smoking. For example, the Learn to Quit App had high usability scores, meaning users found it easy to use. It was also more engaging than other apps, with users spending more time on it daily. Another study found that the quitSTART app had higher engagement levels compared to QuitGuide, especially among young adults with psychotic disorders. These findings suggest that smoking cessation apps can be effective and engaging treatments for people with mental health disorders, although more research is needed to confirm their effectiveness. ^{1 2 3 4 5}

What safety data exists for smoking cessation apps for mental health disorders?

The available research primarily focuses on the usability and acceptability of smoking cessation apps among individuals with serious mental illness (SMI), including psychotic disorders and PTSD. Studies have evaluated apps like QuitGuide, quitSTART, and Stay Quit Coach, finding them generally usable and acceptable for these populations. However, specific safety data is not detailed in the provided research. The studies suggest that these apps are engaging and may require initial coaching and notifications to maintain user engagement, but further efficacy and safety testing is warranted. ^{2 3 6 7 8}

Is the Quit on the Go App a promising treatment for helping people with mental health disorders quit smoking?

Yes, the Quit on the Go App is a promising treatment because mobile apps have been shown to provide motivation and support for quitting smoking, and they are appealing and usable for people with mental health disorders. ^{2 8 9 10 11}

Research Team

Roger Vilardaga, PhD

Principal Investigator

Wake Forest University

Eligibility Criteria

This trial is for adults with serious mental illness (SMI) like schizophrenia or bipolar disorder who smoke at least 5 cigarettes daily, have functional impairment, and are currently in psychiatric treatment. They must want to quit smoking within the next six months and be able to use nicotine replacement therapy (NRT). Pregnant individuals, those in an acute psychotic episode, using e-cigarettes frequently, or receiving other cessation help can't join.

Inclusion Criteria

I have difficulties with day-to-day activities due to my health condition.

Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months

I have been diagnosed with a mental health condition like schizophrenia or bipolar disorder.

Exclusion Criteria

I am currently getting help to quit smoking.

Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998)

I have used e-cigarettes or other tobacco products for more than 10 days in the last month.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Quit on the Go app intervention or Brief Advice, combined with Nicotine Replacement Therapy for 8 weeks

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for smoking abstinence and app engagement at 1-month, 3-month, and 6-month intervals

6 months

3 visits (in-person or virtual)

Treatment Details

Interventions

• Learn to Quit App (Behavioural Intervention)
• Nicotine gum (Hormone Therapy)
• Nicotine Lozenges (Hormone Therapy)
• Nicotine patch (Hormone Therapy)
• Quit on the Go App (Behavioural Intervention)
• Smartphone coaching (Behavioural Intervention)

Trial Overview The study compares a new app called 'Quit on the Go', designed for people with SMI aiming to stop smoking, against standard care which includes brief advice and NRT such as patches, gum, or lozenges. Participants will be randomly assigned to one of these two approaches at Duke University and Univ. at Buffalo.

Participant Groups

Group I: Brief Advice (Standard of Care) Experimental Treatment 4 Interventions

Brief Advice and Combined Nicotine Replacement Therapy (patches and gum or lozenges) has been recommended by the US Clinical Practice Guidelines for patients with psychiatric illness. Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. The intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum).

Group II: "Quit on the Go" (formerly "Learn to Quit") Experimental Treatment 5 Interventions

A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). Participants also receive technical smartphone coaching for the first 4 weeks of the study.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Satish K. Tripathi

University at Buffalo

Chief Executive Officer since 2011

PhD in Computer Science from University of Toronto

Brian M. Parker

University at Buffalo

Chief Medical Officer since 2021

MD from University of Pennsylvania

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

The Learn to Quit (LTQ) app, designed for individuals with serious mental illness (SMI), demonstrated higher usability and user engagement compared to the general population's QuitGuide app, with users engaging with LTQ for an average of 14 minutes per day.

Safety assessments indicated that LTQ is safe for users with SMI, suggesting it could be an effective tool for smoking cessation in this population, warranting further testing in a Phase II study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative, multimethod case studies of learn to quit, an acceptance and commitment therapy smoking cessation app designed for people with serious mental illness. Vilardaga, R., Rizo, J., Ries, RK., et al.[2020]

Both QuitGuide and quitSTART apps were found to be usable and acceptable for young adult smokers with serious mental illness, including those with psychotic disorders, indicating their potential as effective smoking cessation tools.

The quitSTART app showed significantly higher engagement levels compared to QuitGuide, suggesting that it may be more effective in promoting smoking cessation among this population, although initial coaching and notifications may enhance its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Usability of Mobile Apps for Smoking Cessation Among Young Adults With Psychotic Disorders and Other Serious Mental Illness. Gowarty, MA., Aschbrenner, KA., Brunette, MF.[2023]

The QuitPal smoking cessation app was evaluated for usability among individuals with serious mental illness, revealing below-average usability and a need for significant guidance during use.

User experience insights indicated that breaking down the cessation process into smaller steps and incorporating a reward system could enhance the app's effectiveness for this population, which has higher smoking rates compared to the general public.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Experience Evaluation of a Smoking Cessation App in People With Serious Mental Illness. Vilardaga, R., Rizo, J., Kientz, JA., et al.[2019]

Smoking cessation apps can be acceptable and feasible for individuals with schizophrenia, but they may require customization to better meet their specific needs.

Lack of motivation is a significant barrier for this population, suggesting that incorporating engaging features like games, rewards, and social support could enhance app usage and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation Apps for People with Schizophrenia: How Feasible Are m-Health Approaches? Sawyer, C., Hassan, L., Guinart, D., et al.[2023]

Digital interventions for smoking cessation in patients with serious mental illness (SMI) show promise, with the mSMART MIND program achieving 7-day abstinence rates between 16-40%.

The study found that while adverse events were rare, the overall quality of the included studies was fair to good, highlighting the need for larger trials with standardized measures to better assess effectiveness and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of digital interventions for smoking cessation in patients with serious mental illness. Martinez Agulleiro, L., Patil, B., Firth, J., et al.[2023]

A new mobile app was developed for collecting data on tobacco use among psychiatric patients and the general population, focusing on data security and participant benefits.

The app enhances data quality by preventing human error, validating responses during interviews, and automating data tabulation, which could encourage more research tool usage among nurses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the TabacoQuest app for computerization of data collection on smoking in psychiatric nursing. Oliveira, RM., Duarte, AF., Alves, D., et al.[2022]

The Stay Quit Coach (SQC) app was found to be an acceptable and useful tool for smoking cessation among US military veterans with PTSD, with 85% of participants engaging in qualitative interviews expressing positive feedback.

Participants highlighted the convenience of mobile technology for smoking cessation and suggested improvements such as increased personalization and self-tracking features, indicating a strong interest in interactive app functionalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Examination of Stay Quit Coach, A Mobile Application for Veteran Smokers With Posttraumatic Stress Disorder. Herbst, E., McCaslin, SE., Hassanbeigi Daryani, S., et al.[2020]

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 651 smartphone apps analyzed for smoking cessation, only 15 were focused specifically on this goal, with a majority categorized as calendars or information tools.

The evaluated apps showed a low adherence to established smoking cessation guidelines, with a mean score of only 12.8, indicating a need for improvement and the development of future apps based on evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of smartphone apps for smoking cessation available in Portuguese. Formagini, TD., Ervilha, RR., Machado, NM., et al.[2018]

The study aims to evaluate the effectiveness of the 'CureApp Smoking Cessation' (CASC) app in improving smoking cessation rates among individuals with nicotine dependence, alongside a standard 12-week treatment program, with a total of 580 participants expected to be recruited.

CASC is designed to enhance treatment outcomes by providing personalized support through video tutorials, AI advice, and CO monitoring, and the primary outcome will be the continuous abstinence rate from weeks 9-24, which is anticipated to be significantly higher than that of a control app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial. Nomura, A., Tateno, H., Masaki, K., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Formative, multimethod case studies of learn to quit, an acceptance and commitment therapy smoking cessation app designed for people with serious mental illness. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptability and Usability of Mobile Apps for Smoking Cessation Among Young Adults With Psychotic Disorders and Other Serious Mental Illness. [2023]

3. England pubmed.ncbi.nlm.nih.gov

User Experience Evaluation of a Smoking Cessation App in People With Serious Mental Illness. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Smoking Cessation Apps for People with Schizophrenia: How Feasible Are m-Health Approaches? [2023]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review of digital interventions for smoking cessation in patients with serious mental illness. [2023]

6. Brazil pubmed.ncbi.nlm.nih.gov

Development of the TabacoQuest app for computerization of data collection on smoking in psychiatric nursing. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A Qualitative Examination of Stay Quit Coach, A Mobile Application for Veteran Smokers With Posttraumatic Stress Disorder. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

10. Brazil pubmed.ncbi.nlm.nih.gov

A review of smartphone apps for smoking cessation available in Portuguese. [2018]

11. Canada pubmed.ncbi.nlm.nih.gov

A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial. [2020]