Smoking Cessation App for Mental Illness

Overseen By Joseph Gennusa

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Intention to become pregnant

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to help people with serious mental illness (SMI) quit smoking. The focus is on using the LTQ app, a smoking cessation tool, combined with nicotine replacement therapy, to support those attending outpatient mental health clinics. The goal is to determine if this approach effectively helps individuals with SMI stop smoking. Ideal candidates for this trial are regular smokers who want to quit and are part of the Johns Hopkins Bayview Adult Psychiatry Program. Participants must also have a smartphone to use the app. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly improve smoking cessation strategies for individuals with SMI.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this app is safe for individuals with serious mental illness?

Research has shown that the LTQ app is safe for people with serious mental illness (SMI). Studies have found LTQ to be easy to use and engaging for these individuals. Tests of mental health indicate that using LTQ does not harm mental well-being.

Some users might find the app harder to use when their mental health symptoms worsen, but this does not indicate that the app is unsafe. Instead, it highlights the need for support during challenging times. Overall, LTQ appears to be well-accepted and does not cause major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smoking Cessation App for Mental Illness because it combines technology with traditional nicotine replacement therapy in a new way. Unlike standard treatments like nicotine patches or prescription medications, this app-based approach offers personalized support directly through a smartphone, making it more accessible and adaptable to individual needs. This innovative method is particularly promising for people with serious mental illness, as it provides ongoing, tailored assistance that can be accessed anytime, potentially improving adherence and success rates in quitting smoking.

What evidence suggests that the LTQ app is effective for smoking cessation in individuals with serious mental illness?

Research has shown that the LTQ app is easy to use and engaging for people with serious mental illness (SMI) who want to quit smoking. One study found that over 16 weeks, participants using the LTQ app smoked fewer cigarettes daily compared to those using other apps. This trial will evaluate the effectiveness of the LTQ app combined with nicotine replacement therapy for consumers with SMI at an outpatient community mental health clinic. Another study found that increased use of the LTQ app led to greater reductions in smoking. These results suggest that LTQ could be a helpful tool for quitting smoking in this group. ^{1 3 6 7 8}

Who Is on the Research Team?

Gail Daumit

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for regular smokers with serious mental illness (SMI) who are part of the Johns Hopkins Bayview Adult Psychiatry Program and own a smartphone. They must be willing to quit smoking. Pregnant women or those planning to become pregnant within 3 months cannot participate.

Inclusion Criteria

I am a smoker but willing to quit.

I am willing to participate in the trial.

Must be a mental health consumer at Johns Hopkins Bayview Adult Psychiatry Program

Exclusion Criteria

I am not pregnant and do not plan to become pregnant in the next 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the LTQ smoking cessation app and receive nicotine replacement therapy, with social support via social media

13 weeks

Follow-up

Participants are monitored for changes in smoking behavior and social support

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LTQ

Trial Overview The study is testing a new smoking cessation app designed specifically for individuals with SMI. Participants will use this digital therapeutic tool remotely, and its effectiveness in helping them quit smoking will be evaluated.

How Is the Trial Designed?

Group I: Consumers who smoke at outpatient community mental health clinic Experimental Treatment 1 Intervention

Consumers with serious mental illness who attend outpatient community mental health clinic will participate in a smoking cessation with the LTQ application and nicotine replacement therapy

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30445507/

Formative, multimethod case studies of learn to quit ... - PubMed LTQ appears to be a usable and engaging smoking cessation app in people with SMI. An optimized version of LTQ should be tested in a Phase II ...

2. dukespace.lib.duke.edu dukespace.lib.duke.edu/items/3440f53b-8c8d-4425-bff5-7b7c0bb6bba5

Formative, multimethod case studies of learn to quit, an ... LTQ appears to be a usable and engaging smoking cessation app in people with SMI. An optimized version of LTQ should be tested in a Phase II study.

3. withpower.com withpower.com/trial/phase-mental-disorders-8-2021-f0c13?condition=SAD&overallStatus=Recruiting&hasNoPlacebo=false

Smoking Cessation App for Mental Health Disorders (MTQT Trial) Both QuitGuide and quitSTART apps were found to be usable and acceptable for young adult smokers with serious mental illness, including those with psychotic ...

4. mdpi.com mdpi.com/resolver?pii=bs12080265

Smoking Cessation Apps for People with Schizophrenia Over the 16-week follow-up period, both apps led to a reduction in cigarettes smoked, although the mean reduction in cigarettes per day was higher for LTQ ...

5. researchgate.net researchgate.net/publication/353697482_Engagement_with_a_digital_therapeutic_for_smoking_cessation_designed_for_persons_with_psychiatric_illness_fully_mediates_smoking_outcomes_in_a_pilot_randomized_controlled_trial

(PDF) Engagement with a digital therapeutic for smoking ... The main outcome was reductions in cigarettes per day from baseline to the four-month endpoint. Mediational analysis followed the Preacher and Hayes bootstrap ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7184916/

Formative, multimethod case studies of learn to quit, an ... Measures of psychiatric functioning suggested the safety of LTQ in people with SMI. LTQ appears to be a usable and engaging smoking cessation ...

7. ctv.veeva.com ctv.veeva.com/study/developing-and-pilot-testing-a-remote-smoking-cessation-digital-therapeutic-for-individuals-with-ser

Developing and Pilot Testing a Remote Smoking Cessation ... Learn to Quit (LTQ), an evidence-based smoking cessation app tailored to the needs of individuals with serious mental illness (SMI) that ...

8. researchgate.net researchgate.net/publication/351395075_Acceptability_and_Usability_of_Mobile_Apps_for_Smoking_Cessation_Among_Young_Adults_With_Psychotic_Disorders_and_Other_Serious_Mental_Illness

Acceptability and Usability of Mobile Apps for Smoking ... Background Young adults with serious mental illness (SMI) have higher smoking rates and lower cessation rates than young adults without SMI.