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

Official title

Cognitive Behavioural Therapy for Smoking Cessation in Incarcerated Men: Efficacy and Predictors of Treatment Outcomes

Overview

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

• 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
• 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

Primary outcome measures

• Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up [Time frame: baseline to 1-month follow-up]
• Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up [Time frame: baseline to 3-month follow-up]

Secondary outcome measures (10)

• Number of Cigarettes Smoked Per Day at 1-Month Follow-Up [Time frame: Baseline to 1-month follow-up]
• Number of Cigarettes Smoked Per Day at 3-Month Follow-Up [Time frame: Baseline to 3-month follow-up]
• Nicotine Dependence (FTND Score) at 1-Month Follow-Up [Time frame: Baseline to 1-month follow-up]
• Nicotine Dependence (FTND Score) at 3-Month Follow-Up [Time frame: Baseline to 3-month follow-up]
• Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up [Time frame: Baseline to 1-month follow-up]
• Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up [Time frame: Baseline to 3-month follow-up]
• Self-Efficacy for Smoking Cessation at 1-Month Follow-Up [Time frame: Baseline to 1-month follow-up]
• Self-Efficacy for Smoking Cessation at 3-Month Follow-Up [Time frame: Baseline to 3-month follow-up]
• Predictors of smoking abstinence at 1-month follow-up [Time frame: Baseline to 1 month follow-up]
• Predictors of smoking abstinence at 3-month follow-up [Time frame: Baseline to 3 month follow-up]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• Centre pénitentiaire Paris-La Santé (Paris-La Santé prison) — Paris

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. PMID 23228222

Identifiers

NCT: NCT06873009 · 24.05937.000428

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗