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

NCT06873009 | Enrolling By Invitation

• 1 other identifier: 24.05937.000428
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Tobacco Use; Smoking Cessation; Cognitive Behavioral Therapy; Prisoners

Keywords

Tobacco use; Smoking cessation; Cognitive Behavioral Therapy; Prisoners

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Number of Cigarettes Smoked Per Day at 1-Month Follow-Up

  Baseline to 1-month follow-up

• Number of Cigarettes Smoked Per Day at 3-Month Follow-Up

  Baseline to 3-month follow-up

• Nicotine Dependence (FTND Score) at 1-Month Follow-Up

  Baseline to 1-month follow-up

• Nicotine Dependence (FTND Score) at 3-Month Follow-Up

  Baseline to 3-month follow-up

• Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up

  Baseline to 1-month follow-up

Study Arms (3)

Cognitive-Behavioral Therapy (CBT) group

EXPERIMENTAL

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

Health Education Group

ACTIVE COMPARATOR

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

Waitlist Control Group

NO INTERVENTION

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.

Interventions

Cognitive-Behavioral Therapy (CBT) for Smoking Cessation BEHAVIORAL

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

Cognitive-Behavioral Therapy (CBT) group

Health Education Session on Tobacco Use OTHER

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

Health Education Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male individuals currently incarcerated at Maison d'Arrêt Paris-La Santé.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Paris Nanterre University: collaborator

Study Sites (1)

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

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Tobacco Use; Smoking Cessation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Xavier Laqueille, MD, Head of Department

  GHU Paris Psychiatrie et Neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)