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Enrolling by Invitation

NCT Number: NCT06873009

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

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.

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Key information

Conditions

Tobacco Use Behavior Cognitive Behavioral Therapy Health Behavior Prisoners Smoking Cessation

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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

Primary outcomes

  1. Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up

    Time frame: baseline to 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.

  2. Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up

    Time frame: baseline to 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 outcomes

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

    Time frame: Baseline to 1-month follow-up

    The average number of cigarettes smoked per day, as self-reported by participants, will be assessed to evaluate changes in tobacco use. This outcome will be compared to baseline and between treatment groups (CBT, health education, control) at 1-month follow-up.

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

    Time frame: Baseline to 3-month follow-up

    The average number of cigarettes smoked per day, as self-reported by participants, will be assessed to evaluate changes in tobacco use. This outcome will be compared to baseline and between treatment groups (CBT, health education, control) at 3-month follow-up.

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

    Time frame: Baseline to 1-month follow-up

    Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND), with scores ranging from 0 (no dependence) to 10 (high dependence). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).

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

    Time frame: Baseline to 3-month follow-up

    Nicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND), with scores ranging from 0 (no dependence) to 10 (high dependence). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).

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

    Time frame: Baseline to 1-month follow-up

    Craving levels will be assessed using the French Tobacco Craving Questionnaire - 12 items (FTCQ-12), with total scores ranging from 12 (lowest craving) to 60 (highest craving). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).

  6. Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up

    Time frame: Baseline to 3-month follow-up

    Craving levels will be assessed using the French Tobacco Craving Questionnaire - 12 items (FTCQ-12), with total scores ranging from 12 (lowest craving) to 60 (highest craving). Changes in scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).

  7. Self-Efficacy for Smoking Cessation at 1-Month Follow-Up

    Time frame: Baseline to 1-month follow-up

    Self-efficacy will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). Changes in self-efficacy scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).

  8. Self-Efficacy for Smoking Cessation at 3-Month Follow-Up

    Time frame: Baseline to 3-month follow-up

    Self-efficacy will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not confident at all) to 10 (very confident). Changes in self-efficacy scores will be compared from baseline to follow-up assessments and between treatment groups (CBT, health education, control).

  9. Predictors of smoking abstinence at 1-month follow-up

    Time frame: Baseline to 1 month follow-up

    Logistic regression will be used to examine predictors of abstinence (defined as self-reported 7-day abstinence confirmed by CO ≤ 8 ppm) at 1-month follow-up. Candidate predictors include baseline impulsivity (UPPS), anxiety and depression (HADS), nicotine dependence (FTND), education level, self-efficacy (VAS), motivation (ASSIST), ADHD symptoms (ASRS), PTSD symptoms (PCL-5), other substance use (ASSIST), and withdrawal symptoms (MNWS).

  10. Predictors of smoking abstinence at 3-month follow-up

    Time frame: Baseline to 3 month follow-up

    Logistic regression will be used to examine predictors of abstinence (defined as self-reported 7-day abstinence confirmed by CO ≤ 8 ppm) at 3-month follow-up. Candidate predictors include baseline impulsivity (UPPS), anxiety and depression (HADS), nicotine dependence (FTND), education level, self-efficacy (VAS), motivation (ASSIST), ADHD symptoms (ASRS), PTSD symptoms (PCL-5), other substance use (ASSIST), and withdrawal symptoms (MNWS).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Collaborators

  • Paris Nanterre University

Registry information

Official study title

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

Acronym: PriSanTabac

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 12, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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