Can Cognitive Behavioural Therapy Help Incarcerated Men Quit Smoking? Efficacy and Predictors of … (NCT06873009) | Clinical Trial Compass
By InvitationNot Applicable
Can Cognitive Behavioural Therapy Help Incarcerated Men Quit Smoking? Efficacy and Predictors of Treatment Outcomes
France202 participantsStarted 2025-06-18
Plain-language summary
The goal of this clinical trial is to evaluate whether a brief group-based psychological intervention using cognitive-behavioral therapy (CBT) helps people in prison quit smoking. Researchers will compare this intervention to a health education program and a control group (waitlist) to see which approach is most effective.
The main questions this study aims to answer are:
* Does the CBT-based group intervention help more participants quit smoking compared to the health education group and the control group?
* Do participants in the CBT-based group intervention smoke fewer cigarettes per day one month after the intervention compared to the other groups?
* Do participants in the CBT-based group intervention have lower nicotine dependence ?
* What individual factors (e.g., motivation to quit, nicotine dependence, craving intensity, self-efficacy, withdrawal symptoms, anxiety, depression, ADHD, and PTSD) predict success in the CBT and Health education groups?
Participants will be randomly assigned to one of three groups:
* CBT group: Three group sessions (1.5 hours each) using CBT and motivational approaches to quitting smoking.
* Health education group: One group session (1 hour) providing information on smoking and its health risks.
* Control group: No intervention for three months (waitlist). All participants will complete an initial assessment, attend their assigned group sessions, and return for follow-up visits at 1 month and 3 months. Their smoking status will be measured through self-reports and carbon monoxide (CO) expired levels.
Who can participate
Age range
18 Years
Sex
MALE
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:
* Male individuals currently incarcerated at Maison d'Arrêt Paris-La Santé.
* Aged 18 years or older at the time of inclusion.
* Current smoker, defined as having smoked daily in the past 30 days, or having an occasional smoking pattern of at least 5 cigarettes during the past 30 days.
* Able to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
* Sentence length of at least 6 months, or if in pretrial detention, having a scheduled trial date within at least 6 months.
Exclusion Criteria:
* Age under 18 years at the time of inclusion.
* Inability to speak and understand French well enough to follow the study procedures and actively participate in group sessions.
* Sentence length of less than 6 months, or if in pretrial detention, having a scheduled trial date in less than 6 months or no available information about the trial date.
* Severe cognitive impairment that affects comprehension and participation in the study.
* Unstable psychiatric conditions (including acute psychotic disorders, severe mood disorders, severe anxiety disorders).
* Individuals under legal guardianship or conservatorship (e.g., placed under tutelage, curatorship, or temporary guardianship).
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
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up
Timeframe: baseline to 1-month follow-up
2
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up