CBT for Adult Inmates With ADHD

Sponsor
Universidad Europea de Valencia
Study ID
NCT06080373
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PROBECO — BEHAVIORAL
    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.
  • Formulation-based cognitive behavioral therapy — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Oct 12, 2023
Start date
Sep 30, 2027
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
111 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Formulated-based cognitive behavioral therapy
    Participants randomized to the CBT group will receive a minimum of 13 and a maximum of 22 sessions of individual formulation-based CBT. It will be delivered by psychologists trained in CBT, according to a manual that will be available soon. Prior to intervention, a behavioral assessment is conducted to operationalize each case's clinically relevant behaviors, antecedents, and maintenance stimuli. Each case will be formulated and presented to the participant in simple and easy to understand language. To illustrate this, a schematic formulation of the typical case of an adult with ADHD is shown in Figure 2. Specific behavioral goals will then be agreed upon for each participant. To achieve these goals, various treatment strategies will be presented in the following sessions. The choice of strategies, the order in which they are applied, and the duration of each module will be customized for each participant according to the case formulation.
  • Active Comparator: PROBECO and social therapeutic establishments
    The Spanish participants assigned to the active control group will receive the PROBECO. It is a group program designed by the Spanish Penitentiary Agency for its application with inmates convicted of different types of violent crimes . Its main goals are to eradicate criminal behavior and reduce recidivism, to modify the relevant dynamic risk factors related to general delinquency, and to introduce new social skills and prosocial values. It consists of four phases: (I) general intervention: aimed at the acquisition of social skills; (II) specific intervention: consists of four specific educational itineraries; (III) relapse prevention; (IV) follow-up. Similarly, German participants will be assigned to a special type of prison known as a social therapeutic facility, where they will undergo compulsory psychotherapy focused primarily on relapse prevention.
  • No Intervention: Waitlist
    Participants in waitlist control group will receive no treatment while experimental groups are treated. They will be offered to receive CBT after the study.

Primary Outcome Measure

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

Central Contacts

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