Smoking Cessation App for Mental Health Disorders

(MTQT Trial)

Not currently recruiting at 3 trial locations

Overseen By Caitlyn Arnold

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Substance use, Acute psychosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app, Quit on the Go, designed to help individuals with serious mental illnesses quit smoking. The study compares the app's effectiveness to standard smoking cessation methods, such as brief advice and nicotine patches. Individuals diagnosed with conditions like schizophrenia or bipolar disorder, who smoke at least five cigarettes a day and wish to quit, may be suitable for this trial. Participants will also use nicotine replacement products, like patches or gum, alongside the app. As an unphased trial, this study provides a unique opportunity to explore innovative, personalized support for quitting smoking.

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 prior data suggests that the Quit on the Go app is safe for people with serious mental illness?

Research has shown that the Quit on the Go app, formerly known as "Learn to Quit," is well-received by individuals with serious mental health issues. This app is specifically designed to help those with mental health disorders quit smoking. Studies have found it both practical and suitable for these individuals.

One study tested the app with people who have both a tobacco addiction and a mental illness. It proved to be an effective tool for helping them quit smoking. Participants found the app easy to use and helpful, with no major safety issues reported.

Overall, the Quit on the Go app appears to be a safe choice for helping people quit smoking, especially those facing mental health challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The "Quit on the Go" app is unique because it integrates Acceptance and Commitment Therapy (ACT) specifically tailored for individuals with serious mental illnesses. Unlike traditional smoking cessation methods that rely solely on nicotine replacement therapy (NRT), this app combines behavioral therapy with NRT patches and gum or lozenges, addressing both smoking cessation and mental health symptoms simultaneously. Researchers are excited about this approach because it offers personalized smartphone coaching, which could enhance user engagement and improve quit rates by supporting mental well-being alongside smoking cessation.

What evidence suggests that this trial's treatments could be effective for smoking cessation in people with serious mental illness?

Research has shown that digital tools, like the Quit on the Go app available to participants in this trial, can significantly aid smoking cessation. One study found that personalized apps increase the chances of quitting by 77% compared to other methods. Another study demonstrated that individuals using an app based on Acceptance and Commitment Therapy (ACT) were 1.49 times more likely to quit smoking. This app is specifically designed for people with serious mental illness, who often smoke at higher rates. Participants using the Quit on the Go app will also receive nicotine replacement therapy, which helps people quit smoking. Early results suggest that the app is user-friendly and well-received. ^{1 6 7 8 9}

Who Is on the Research Team?

Roger Vilardaga, PhD

Principal Investigator

Wake Forest University

Are You a Good Fit for This Trial?

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

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

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

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

Exclusion Criteria

I am currently getting help to quit smoking.

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

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)

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Learn to Quit App
• Nicotine gum
• Nicotine Lozenges
• Nicotine patch
• Quit on the Go App
• Smartphone coaching

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.

How Is the Trial Designed?

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+

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

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 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]

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]

A study of 252 smoking cessation apps for iPhone and 148 for Android revealed that popular apps generally have low adherence to U.S. Public Health Service guidelines, scoring an average of only 12.9 out of 42 on the Adherence Index.

None of the apps recommended calling a quitline, and only 4.1% suggested using approved medications, indicating a significant gap in evidence-based support for users trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. Abroms, LC., Lee Westmaas, J., Bontemps-Jones, J., et al.[2022]

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]

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]

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 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]

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]

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]

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]

Citations

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Study Details | NCT05030272 | Comparing Two Behavioral ... Specifically, the proposed trial will test whether a tailored smoking cessation app for people with serious mental illness, Quit on the Go, results in higher ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5790963/

User-Centered Design of Learn to Quit, a Smoking ... This report describes the systematic development of the first smoking cessation app tailored to people with SMI, a population with very high rates of nicotine ...

3. nature.com nature.com/articles/s41562-025-02295-2

Efficacy of digital interventions for smoking cessation by ... Unmerged results, presented in the Supplementary Information, did not significantly differ. Personalized apps showed a 77% higher quit rate ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214782924000307

Evaluation of effectiveness and acceptability of a ... The present pilot study aims to examine the preliminary effectiveness and acceptability of a cognitive-behavioral treatment combined with a smartphone App.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7506605/

Efficacy of Smartphone Applications for Smoking Cessation Participants assigned to the smartphone application based on ACT had 1.49 times higher odds of quitting smoking compared with the participants assigned to the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31667501/

Pilot Randomized Controlled Trial of a Novel Smoking ... This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder ...

7. mhealth.jmir.org mhealth.jmir.org/2024/1/e55239

Development and Usability Study - JMIR mHealth and uHealth Our study demonstrated that MO is a feasible mobile phone app with high acceptability and usability and can effectively deliver smoking cessation support.

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2770816

Efficacy of Smartphone Applications for Smoking Cessation This randomized clinical trial examines the efficacy of a smartphone application for smoking cessation based on acceptance and commitment ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0306460325001157

Exploring relationships among smoking cessation app use, ... Smoking cessation apps (SCAs) provide individuals with personalized quit plans, information about smoking cessation treatments, craving management strategies, ...