Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings (NCT05030272) | Clinical Trial Compass
CompletedNot Applicable
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
United States343 participantsStarted 2021-09-21
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version
. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
. Age 18 and older;
. Willing and medically eligible to use NRT;
. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CO-verified 7-day point-prevalence abstinence at 6-month follow-up
. 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.
. 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);
. Being pregnant or the intention to become pregnant in the next 6 months;
. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
. Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days.
. 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).