Clinical trial NCT06873009: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco Use
Smoking Cessation
Cognitive Behavioral Therapy
Prisoners
Keywords: Tobacco use
Smoking cessation
Cognitive Behavioral Therapy
Prisoners
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Paris Nanterre University
First posted: 2025-03-12
Enrollment: 202
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up
timeFrame: 1-month follow-up
measure: Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Reduction in the Number of Cigarettes Smoked Per Day at 1-Month Follow-Up
timeFrame: Baseline and 1-month follow-up
measure: Reduction in the Number of Cigarettes Smoked Per Day at 3-Month Follow-Up
timeFrame: Baseline and 3-month follow-up
measure: Change in Nicotine Dependence (FTND Score) at 1-Month Follow-Up
timeFrame: Baseline and 1-month follow-up
measure: Change in Nicotine Dependence (FTND Score) at 3-Month Follow-Up
timeFrame: Baseline and 3-month follow-up
measure: Change in Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up
timeFrame: Baseline and 1-month follow-up
measure: Change in Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up
timeFrame: Baseline and 3-month follow-up
measure: Change in Self-Efficacy for Smoking Cessation at 1-Month Follow-Up
timeFrame: Baseline and 1-month follow-up
measure: Change in Self-Efficacy for Smoking Cessation at 3-Month Follow-Up
timeFrame: Baseline and 3-month follow-up
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre pénitentiaire Paris-La Santé (Paris-La Santé prison)
state: Ile-de-France
Study officials:
affiliation: GHU Paris Psychiatrie et Neurosciences
name: Xavier Laqueille, MD, Head of Department
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.