Cognitive-Behavioral Therapy (CBT) for Smoking CessationHealth Education Session on Tobacco Use
Cognitive-Behavioral Therapy (CBT) for Smoking Cessation: A structured three-session group intervention (1.5 hours per session over three weeks) using cognitive-behavioral and motivational strategies to enhance motivation, manage cravings, and prevent relapse.
Associated Arm: CBT Group
Health Education Session on Tobacco Use: A single-session group intervention (1 hour) providing information on the health risks of tobacco use, addiction mechanisms, and the long-term benefits of quitting smoking.
Associated Arm: Health Education Group
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up — baseline to 1-month follow-up Smoking abstinence will be assessed through self-reported smoking status and verified by exhaled carbon monoxide (CO) levels measured using a CO monitor. Participants who self-report smoking abstinence and have a CO level below 8 parts per million (ppm) will be classified as abstinent. A CO level ≥8 ppm will indicate continued smoking.
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up — baseline to 3-month follow-up Smoking abstinence will be assessed through self-reported smoking status and verified by exhaled carbon monoxide (CO) levels measured using a CO monitor. Participants who self-report smoking abstinence and have a CO level below 8 parts per million (ppm) will be classified as abstinent. A CO level ≥8 ppm will indicate continued smoking.
Trial sites (1)
Facility
City
Region
Status
Centre pénitentiaire Paris-La Santé (Paris-La Santé prison)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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