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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
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
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
Centre pénitentiaire Paris-La Santé (Paris-La Santé prison)
Paris, Île-de-France Region, France
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 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.
Time frame: baseline to 1-month follow-up
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 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.
Time frame: baseline to 3-month follow-up
Number of Cigarettes Smoked Per Day at 1-Month Follow-Up
The average number of cigarettes smoked per day, as self-reported by participants, will be assessed to evaluate changes in tobacco use. This outcome will be compared to baseline and between treatment groups (CBT, health education, control) at 1-month follow-up.
Time frame: Baseline to 1-month follow-up
Number of Cigarettes Smoked Per Day at 3-Month Follow-Up
The average number of cigarettes smoked per day, as self-reported by participants, will be assessed to evaluate changes in tobacco use. This outcome will be compared to baseline and between treatment groups (CBT, health education, control) at 3-month follow-up.
Time frame: Baseline to 3-month follow-up
Nicotine Dependence (FTND Score) at 1-Month Follow-Up
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND), with scores ranging from 0 (no dependence) to 10 (high dependence). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Time frame: Baseline to 1-month follow-up
Nicotine Dependence (FTND Score) at 3-Month Follow-Up
Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND), with scores ranging from 0 (no dependence) to 10 (high dependence). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Time frame: Baseline to 3-month follow-up
Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up
Craving levels will be assessed using the French Tobacco Craving Questionnaire - 12 items (FTCQ-12), with total scores ranging from 12 (lowest craving) to 60 (highest craving). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Time frame: Baseline to 1-month follow-up
Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up
Craving levels will be assessed using the French Tobacco Craving Questionnaire - 12 items (FTCQ-12), with total scores ranging from 12 (lowest craving) to 60 (highest craving). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Time frame: Baseline to 3-month follow-up
Self-Efficacy for Smoking Cessation at 1-Month Follow-Up
Self-efficacy will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). Changes in self-efficacy scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Time frame: Baseline to 1-month follow-up
Self-Efficacy for Smoking Cessation at 3-Month Follow-Up
Self-efficacy will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). Changes in self-efficacy scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).
Time frame: Baseline to 3-month follow-up
Predictors of smoking abstinence at 1-month follow-up
Logistic regression will be used to examine predictors of abstinence (defined as self-reported 7-day abstinence confirmed by CO ≤ 8 ppm) at 1-month follow-up. Candidate predictors include baseline impulsivity (UPPS), anxiety and depression (HADS), nicotine dependence (FTND), education level, self-efficacy (VAS), motivation (ASSIST), ADHD symptoms (ASRS), PTSD symptoms (PCL-5), other substance use (ASSIST), and withdrawal symptoms (MNWS).
Time frame: Baseline to 1 month follow-up
Predictors of smoking abstinence at 3-month follow-up
Logistic regression will be used to examine predictors of abstinence (defined as self-reported 7-day abstinence confirmed by CO ≤ 8 ppm) at 3-month follow-up. Candidate predictors include baseline impulsivity (UPPS), anxiety and depression (HADS), nicotine dependence (FTND), education level, self-efficacy (VAS), motivation (ASSIST), ADHD symptoms (ASRS), PTSD symptoms (PCL-5), other substance use (ASSIST), and withdrawal symptoms (MNWS).
Time frame: Baseline to 3 month follow-up
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