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| Name | Class |
|---|---|
| Paris Nanterre University | OTHER |
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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:
Participants will be randomly assigned to one of three groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) group | Experimental | Participants in this group will receive a cognitive-behavioral therapy (CBT)-based intervention designed to help them quit smoking. The intervention consists of three structured group sessions (1.5 hours each) over three weeks, incorporating cognitive-behavioral, motivational, and emotional strategies. The sessions focus on:
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| Health Education Group | Active Comparator | Participants in this group will receive a single-session health education program (1 hour) focused on the risks of smoking and the mechanisms of tobacco addiction. The session is conducted in a group format by a psychologist-nurse team and aims to provide participants with knowledge about the effects of smoking on health. |
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| Waitlist Control Group | No Intervention | Participants in this group will not receive any intervention during the 3-month study period. They will be placed on a waitlist and will have the opportunity to participate in one of the two interventions (CBT or Health Education or both) after the study follow-up is completed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy (CBT) for Smoking Cessation | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline to 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 1-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Laqueille, MD, Head of Department | GHU Paris Psychiatrie et Neurosciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre pénitentiaire Paris-La Santé (Paris-La Santé prison) | Paris | Île-de-France Region | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23228222 | Background | Richmond R, Indig D, Butler T, Wilhelm K, Archer V, Wodak A. A randomized controlled trial of a smoking cessation intervention conducted among prisoners. Addiction. 2013 May;108(5):966-74. doi: 10.1111/add.12084. Epub 2013 Mar 11. |
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Investigators do not plan to share individual participant data (IPD) for this study. The protocol submitted to the Ethics Committee (CPP) does not include any specific provision regarding data sharing, and participants were neither informed nor consented to such use. In accordance with ethical and regulatory requirements, as well as principles of confidentiality and data protection, investigators are therefore unable to make these data available to other researchers.
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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.
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| Health Education Session on Tobacco Use | Other | 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 |
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| 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. | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | Baseline to 3 month follow-up |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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