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

Not Applicable

Not yet recruiting

• Conditions: Tobacco Use; Smoking Cessation; Cognitive Behavioral Therapy; Prisoners

• Registration Number: NCT06873009
• Lead Sponsor: Centre Hospitalier St Anne

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 carbon monoxide (CO) levels compared to the other groups?

* What individual factors (e.g., motivation to quit, nicotine dependence, craving intensity, symptoms of anxiety, depression, ADHD, and PTSD) predict success in the CBT intervention?

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-09
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up	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	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 Outcome Measures

Name	Time	Method
Reduction in the Number of Cigarettes Smoked Per Day at 1-Month Follow-Up	Baseline and 1-month follow-up	Change in the self-reported number of cigarettes smoked per day from baseline to follow-up assessments. A reduction of at least 50% compared to baseline will be considered a significant decrease in tobacco use.
Reduction in the Number of Cigarettes Smoked Per Day at 3-Month Follow-Up	Baseline and 3-month follow-up	Change in the self-reported number of cigarettes smoked per day from baseline to follow-up assessments. A reduction of at least 50% compared to baseline will be considered a significant decrease in tobacco use.
Change in Nicotine Dependence (FTND Score) at 1-Month Follow-Up	Baseline and 1-month follow-up	Change in nicotine dependence as measured by the Fagerström Test for Nicotine Dependence (FTND). Scores range from 0 (no dependence) to 10 (high dependence). A lower post-intervention score indicates reduced nicotine dependence.
Change in Nicotine Dependence (FTND Score) at 3-Month Follow-Up	Baseline and 3-month follow-up	Change in nicotine dependence as measured by the Fagerström Test for Nicotine Dependence (FTND). Scores range from 0 (no dependence) to 10 (high dependence). A lower post-intervention score indicates reduced nicotine dependence.
Change in Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up	Baseline and 1-month follow-up	Change in craving levels measured by the French Tobacco Craving Questionnaire - 12 items (FTCQ-12). The total score ranges from 12 (lowest craving) to 60 (highest craving).
Change in Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up	Baseline and 3-month follow-up	Change in craving levels measured by the French Tobacco Craving Questionnaire - 12 items (FTCQ-12). The total score ranges from 12 (lowest craving) to 60 (highest craving).
Change in Self-Efficacy for Smoking Cessation at 1-Month Follow-Up	Baseline and 1-month follow-up	Change in participants' confidence in their ability to quit smoking, measured using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). A higher post-intervention score indicates greater self-efficacy.
Change in Self-Efficacy for Smoking Cessation at 3-Month Follow-Up	Baseline and 3-month follow-up	Change in participants' confidence in their ability to quit smoking, measured using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). A higher post-intervention score indicates greater self-efficacy.

Trial Locations

Locations (1)

Centre pénitentiaire Paris-La Santé (Paris-La Santé prison); 🇫🇷 Paris, Ile-de-France, France