Department of Psychology, European University of Valencia, Valencia, Spain.
Department of Personality and Psychological Treatments, University of Valencia, Valencia, Spain.
Trials. 2024 Sep 6;25(1):594. doi: 10.1186/s13063-024-08434-w.
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.
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.
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.
ClinicalTrials.gov NCT06080373. Registered on October 12, 2023.
最近的文献表明，ADHD 是发展为反社会行为的一个风险因素，这种行为比社区和其他精神病患者群体更为严重和持久。兴奋剂药物治疗和心理治疗（特别是认知行为疗法，CBT）的结合被认为是 ADHD 成人的一种循证干预措施。相比之下，很少有研究评估 ADHD 成年囚犯药物治疗的疗效，而关于心理治疗疗效的文献几乎不存在。因此，本文介绍了一项评估基于配方的 CBT 方案对 ADHD 囚犯疗效的试验方案。
该研究采用多中心随机对照试验设计。经过筛选和招募后，参与者将被随机分配到 CBT 干预组、一般罪犯治疗计划组或候补组。将进行治疗前和治疗后的自我报告和临床医生报告评估，以及 6 个月和 12 个月的随访评估。这些评估将包括临床（例如，ADHD 症状、抑郁和焦虑症状、自尊、酒精/药物滥用、治疗依从性、生活质量）和犯罪学（例如，累犯和累犯风险）措施。将使用线性混合模型来评估组间差异。
这项研究可能是第一项评估 ADHD 成年囚犯心理治疗干预疗效的研究。预计满足 ADHD 的特定需求不仅会导致先前报告的临床改善（例如，减少 ADHD 和共病症状），而且与一般干预或不干预相比，还会降低累犯风险和累犯率。然而，该设计可能受到监狱环境固有的困难以及在释放后对样本进行随访的限制。
ClinicalTrials.gov NCT06080373。于 2023 年 10 月 12 日注册。
