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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Cognitive-Behavioral Therapy (CBT) for Smoking Cessation
  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
• Другое Health Education Session on Tobacco Use
  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

Первичные конечные точки

• Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 1-Month Follow-Up [Срок оценки: baseline to 1-month follow-up]
• Smoking Abstinence Verified by Carbon Monoxide (CO) Measurement at 3-Month Follow-Up [Срок оценки: baseline to 3-month follow-up]

Вторичные конечные точки (10)

• Number of Cigarettes Smoked Per Day at 1-Month Follow-Up [Срок оценки: Baseline to 1-month follow-up]
• Number of Cigarettes Smoked Per Day at 3-Month Follow-Up [Срок оценки: Baseline to 3-month follow-up]
• Nicotine Dependence (FTND Score) at 1-Month Follow-Up [Срок оценки: Baseline to 1-month follow-up]
• Nicotine Dependence (FTND Score) at 3-Month Follow-Up [Срок оценки: Baseline to 3-month follow-up]
• Smoking Craving (FTCQ-12 Score) at 1-Month Follow-Up [Срок оценки: Baseline to 1-month follow-up]
• Smoking Craving (FTCQ-12 Score) at 3-Month Follow-Up [Срок оценки: Baseline to 3-month follow-up]
• Self-Efficacy for Smoking Cessation at 1-Month Follow-Up [Срок оценки: Baseline to 1-month follow-up]
• Self-Efficacy for Smoking Cessation at 3-Month Follow-Up [Срок оценки: Baseline to 3-month follow-up]
• Predictors of smoking abstinence at 1-month follow-up [Срок оценки: Baseline to 1 month follow-up]
• Predictors of smoking abstinence at 3-month follow-up [Срок оценки: Baseline to 3 month follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT06873009 · 24.05937.000428

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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