CBT for Adult Inmates With ADHD
NCT06080373 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111
Last updated 2026-05-06
Summary
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.
Conditions
- Attention Deficit Hyperactivity Disorder
Interventions
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
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 emotional regulation. D. Maintenance of Treatment Gains: Reviews progress, identifies risk factors, and develops action plans for post-treatment challenges.
Sponsors & Collaborators
-
Universidad Europea de Valencia
lead OTHER
Principal Investigators
-
Carlos López-Pinar, Dr · Universidad Europea de Valencia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-09-30
- Primary Completion
- 2028-09-30
- Completion
- 2029-09-30
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