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

Cognitive Behavioural Therapy for Smoking Cessation in Incarcerated Men: 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation; Tobacco Use; Cognitive Behavioral Therapy; Prisoners
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy (CBT) for Smoking Cessation; Other: Health Education Session on Tobacco Use

• Study Type: Interventional
• Enrollment (Estimated): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Centre pénitentiaire Paris-La Santé (Paris-La Santé prison)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioral Therapy (CBT) group; 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: Increasing motivation to quit smoking,; Managing cravings and withdrawal symptoms,; Developing coping strategies for stress,; Preventing relapse through behavioral and cognitive techniques. This program is adapted from Richmond et al. (2013) The program is based on Richmond et al. (2013) and has been further adapted for the specific context of this study and to align with current recommendations.	Behavioral: 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
Active Comparator: Health Education Group; 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.	Other: 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
No Intervention: Waitlist Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Collaborators: Paris Nanterre University
• Investigators: Principal Investigator: Xavier Laqueille, MD, Head of Department, GHU Paris Psychiatrie et Neurosciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Smoking cessation; Cognitive Behavioral Therapy; Tobacco use; Prisoners
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Tobacco Use; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 24.05937.000428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No