Clinical trial NCT05030272: Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Official title: Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Mental Illness
Recurring Major Depressive Disorder
Bipolar Disorder
Schizophrenia
Schizoaffective Disorder
Persistent Depressive Disorder
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
5. Age 18 and older;
6. Willing and medically eligible to use NRT;
7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).

Exclusion Criteria

1. Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
2. 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);
3. Being pregnant or the intention to become pregnant in the next 6 months;
4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
5. Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days.
6. Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).

Primary outcomes:
measure: CO-verified 7-day point-prevalence abstinence at 6-month follow-up
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Change in average number of cigarettes smoked per day
timeFrame: 1 month follow-up
measure: Change in average number of cigarettes smoked per day
timeFrame: 3 month follow-up
measure: Change in average number of cigarettes smoked per day
timeFrame: 6 month follow-up
measure: Average number of quit attempts per group
timeFrame: 1 month follow-up
measure: Average number of quit attempts per group
timeFrame: 3 month follow-up
measure: Average number of quit attempts per group
timeFrame: 6 month follow-up
measure: Time to 7-day relapse
timeFrame: 1 month follow-up
measure: Time to 7-day relapse
timeFrame: 3 month follow-up
measure: Time to 7-day relapse
timeFrame: 6 month follow-up
measure: 30-day point prevalence abstinence rates
timeFrame: 1 month follow-up
measure: Biochemically confirmed 30-day point prevalence abstinence rates
timeFrame: 3 month follow-up
measure: Biochemically confirmed 30-day point prevalence abstinence rates
timeFrame: 6 month follow-up
measure: Prolonged abstinence rates
timeFrame: 1 month follow-up
measure: Prolonged abstinence rates
timeFrame: 3 month follow-up
measure: Prolonged abstinence rates
timeFrame: 6 month follow-up
measure: Continuous abstinence rates
timeFrame: 1 month follow-up
measure: Continuous abstinence rates
timeFrame: 3 month follow-up
measure: Continuous abstinence rates
timeFrame: 6 month follow-up
Other outcomes:
measure: Average app usability scores
timeFrame: 1 month follow-up
measure: Average user experience scores
timeFrame: 1 month follow-up
measure: Average user experience scores
timeFrame: 3 month follow-up
measure: Average user experience scores
timeFrame: 6 month follow-up
measure: Average frequency of app use
timeFrame: Weeks 0-24
measure: Average duration of app use
timeFrame: Weeks 0-24
measure: Average number of app modules completed
timeFrame: Weeks 0-24
measure: Average acceptance of physical smoking cravings
timeFrame: 1 month follow-up
measure: Average acceptance of physical smoking cravings
timeFrame: 3 month follow-up
measure: Average acceptance of physical smoking cravings
timeFrame: 6 month follow-up
measure: Nicotine patch use
timeFrame: 3 month follow-up
measure: Nicotine gum use
timeFrame: 3 month follow-up
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Roger Vilardaga, PhD
role: PRINCIPAL_INVESTIGATOR
References: