Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings — MTQT  

Schizophrenia Clinical Trial

Official title: Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Status Recruiting

Clinical Trial Summary

The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).

Clinical Trial Description

Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to 317 billion dollar expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide-reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. However, our research has shown that apps developed for the general public have inadequate levels usability and engagement in people with serious mental illness.

In a previous pilot trial of a tailored smoking cessation app for people with serious mental illness, Learn to Quit (NCT03069482), we identified successful recruitment and retention methods for smokers with SMI, demonstrated a 4-fold increase in objectively measured interactions of the novel app, obtained promising cessation rates for the experimental app (12% for Quit on the Go formerly "Learn to Quit" versus 3% for NCI QuitGuide), and identified a reliable methodological approach to conduct a fully-powered randomized controlled trial.

Based on this pilot work, we plan to conduct a clinical trial to test this new model in a diverse and representative sample of the SMI population. 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 levels of smoking abstinence compared to a standard of care intervention for this psychiatric population, Brief Advice. Both interventions will receive combined nicotine replacement therapy. The second aim of this trial is to test a mechanistic model of app efficacy by examining mediators of app engagement and treatment outcomes. Finally, the trial will evaluate the cost-effectiveness of these interventions to inform public health policy regard the use of mHealth in this population.

In a multi-site, two-arm randomized controlled trial, 450 individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Quit on the Go app. In the comparator condition, participants will receive Brief Advice for smoking cessation. Participants in both conditions will receive combined Nicotine Replacement Therapy (standard dosing of nicotine patch plus 5 week course of nicotine gums). Study duration will be 6 months, with 3 follow-up appointments at 1-month, 3-month, and 6-months. Our proposed methods are appropriate given our established procedures during our pilot trial regard to participant assignment, delivery of interventions, data collection and analysis (NCT03069482).

The proposed study meets NIDA's major programmatic priorities of using innovative technologies (e.g., smartphones) and integrating behavioral and pharmacological interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The proposal addresses a serious problem -- high smoking rates in people with SMI -- in a high priority, high cost population, by delivering a novel behavioral intervention for smoking cessation in "real-world" settings. If shown to be effective, the proposed intervention will provide a new model for delivering inexpensive, widely accessible smoking cessation interventions in adults with SMI. ;

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Mental Disorders
• Mental Illness
• Persistent Depressive Disorder
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Tobacco Use Disorder

• NCT number: NCT05030272
• Study type: Interventional
• Source: Duke University
• Contact: Roger Vilardaga, PhD
• Phone: 919 681 3441
• Email: roger.vilardaga@duke.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2021
• Completion date: April 1, 2025