CBT for Adult Inmates With ADHD

Официальное название

Formulation-Based Cognitive-Behavioral Therapy Compared to an Active Control and a Waitlist in Adult Inmates With ADHD: A Randomized Controlled Trial

Обзор

Background Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. The combination of stimulant medication and psychotherapy (particularly cognitive-behavioral therapy, CBT) is considered an evidence-based intervention for adults with ADHD. In contrast, few studies have evaluated the efficacy of medication in adult prisoners with ADHD, and the literature on the efficacy of psychotherapy is virtually nonexistent. Therefore, this article presents the protocol of a trial that will assess the efficacy of a formulation-based CBT program for inmates with ADHD. Methods The study has a multicenter randomized controlled trial design. After screening and recruitment, participants will be randomly assigned to the CBT intervention, a general offender treatment program, or a waitlist. Pre- and post-treatment self-report and clinician-report assessments, as well as 6- and 12-month follow-up assessments will be conducted. These will include both clinical (e.g., ADHD symptoms, depression and anxiety symptoms, self-esteem, alcohol/drug abuse, treatment adherence, quality of life) and criminological (e.g., recidivism and risk of recidivism) measures. Linear mixed models will be used to assess differences between groups. Discussion This study may be the first to evaluate the efficacy of a psychotherapy intervention in adult inmates with ADHD. It is expected that addressing the specific needs of ADHD would not only result in the previously reported clinical improvements (e.g., reduction in ADHD and comorbidity symptoms), but also reduce the risk and rate of recidivism compared to the general intervention or no intervention. However, the design may be limited by the difficulties inherent in the prison setting and in following up the sample after release.

Вмешательства

• Поведенческое PROBECO
  Spanish participants in the active control group will undergo the PROBECO program, designed by the Spanish Penitentiary Agency for various violent crimes. It aims to eradicate criminal behavior, reduce recidivism, and teach social skills. It has four phases. German participants will be placed in social therapeutic facilities for compulsory psychotherapy focused on relapse prevention.
• Поведенческое Formulation-based cognitive behavioral therapy
  The CBT program includes these core modules: A. ADHD Psychoeducation: Provides information on ADHD characteristics, neurobiology, treatments, and their efficacy. Shared with a significant other if available. B. Planning Skills and Distraction Management: Teaches time management, task prioritization, and distraction control techniques. C. Cognitive Restructuring: Based on Ellis' Rational Behavioral Emotive Therapy, it helps participants identify and modify irrational thoughts for better emotio

Первичные конечные точки

• Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID) [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]
• Reoffending rate [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]

Вторичные конечные точки (7)

• Clinical Global Impression (CGI) [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]
• Attention-deficit/hyperactivity rating scale-IV [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]
• Rosenberg self-esteem scale (RSES [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]
• Adult ADHD Quality of Life Questionnaire (AAQoL [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]
• Maudsley Addiction Profile (MAP) [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]
• Beck depression inventory-II (BDI-II) and Beck anxiety inventory (BAI) [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]
• Historical Clinical Risk Management-20 (HCR-20) [Срок оценки: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention]

Критерии участия

Критерии включения

• To have signed written informed consent to participate in the study
• To be between 18 and 65 years of age
• To meet the DSM-5 diagnostic criteria for ADHD (American Psychiatric Association, 2013)
• To have been convicted of at least one crime under Spanish or German criminal law
• To have been incarcerated for at least six months and three or fewer years since the completion of the conviction at the time of eligibility assessment.

Критерии исключения

• To have a severe personality disorder, psychotic disorder, or pervasive developmental disorder as their primary diagnosis, as the intervention would not meet their clinical needs
• To have an IQ of 80 or less, as measured by a standardized IQ test (Raven et al., 1993), due to the complexity of the cognitive components in the CBT program
• To have participated in a previous psychological intervention for ADHD;
• To not be fluent in Spanish or German, depending on the study site.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Lopez-Pinar C, Martinez-Sanchis S, Carbonell-Vaya E, Martinez-Raga J, Retz W. Formulation-based cognitive behavioral therapy compared to an active control and a waitlist in adult inmates with ADHD: study protocol for a randomized controlled trial. Trials. 2024 Sep 6;25(1):594. doi: 10.1186/s13063-024-08434-w. PMID 39243058

Идентификаторы

NCT: NCT06080373 · UEuropeaValencia

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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