Cognitive Behavioral Therapy, Prisoners, Smoking Cessation, Tobacco Use
Conditions
Keywords
Tobacco use, Smoking cessation, Cognitive Behavioral Therapy, Prisoners
Brief 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.
Interventions
BEHAVIORALCognitive-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
OTHERHealth 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
Sponsors
Paris Nanterre University
Centre Hospitalier St Anne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a three-arm randomized controlled trial (RCT) with a parallel design. Participants are randomly assigned to one of three groups: a cognitive-behavioral therapy (CBT) intervention, a health education program, or a waitlist control group. The study aims to evaluate the efficacy of the CBT intervention in helping incarcerated individuals quit smoking, compared to a health education program and a waitlist control group.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Dependence (FTND Score) at 1-Month Follow-Up | Baseline to 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). |
| Nicotine Dependence (FTND Score) at 3-Month Follow-Up | Baseline to 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). |
| Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up | Baseline to 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). |
| Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up | Baseline to 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). |
| Number of Cigarettes Smoked Per Day at 3-Month Follow-Up | Baseline to 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. |
| Self-Efficacy for Smoking Cessation at 3-Month Follow-Up | Baseline to 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). |
| Predictors of smoking abstinence at 1-month follow-up | Baseline to 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). |
| Predictors of smoking abstinence at 3-month follow-up | Baseline to 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). |
| Self-Efficacy for Smoking Cessation at 1-Month Follow-Up | Baseline to 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). |
| Number of Cigarettes Smoked Per Day at 1-Month Follow-Up | Baseline to 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. |
Countries
France
Outcome results
None listed