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

Centre Hospitalier St Anne

Status: Invitation-only

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

Treatments: Other: Health Education Session on Tobacco Use; Behavioral: Cognitive-Behavioral Therapy (CBT) for Smoking Cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT06873009

24.05937.000428

Details and patient eligibility

About

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.

Enrollment: 202 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 3 patient groups

Cognitive-Behavioral Therapy (CBT) group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive-Behavioral Therapy (CBT) for Smoking Cessation

Health Education Group

Active Comparator group

Description:

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.

Treatment:

Other: Health Education Session on Tobacco Use

Waitlist Control Group

No Intervention group

Description:

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.