Can Cognitive Behavioural Therapy Help Incarcerated Men Quit Smoking? Efficacy and Predictors of Treatment Outcomes

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.

NCT Number	NCT06873009
Lead Sponsor	Centre Hospitalier St Anne Collaborators: Paris Nanterre University
Conditions	Tobacco Use, Smoking Cessation, Cognitive Behavioral Therapy, Prisoners
Enrollment	202 participants
Start Date	2025-06-18
Primary Completion	2026-09 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2025-09-03