Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial

NCT ID: NCT06080373

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Formulation-based cognitive behavioral therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

PROBECO

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Carlos López-Pinar

Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos López-Pinar, Dr

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Valencia

Central Contacts

Carlos López-Pinar, Dr

Role: CONTACT

carloslopez.pinar@universidadeuropea.es

+34 665878367

References

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.

Reference Type: DERIVED

PMID: 39243058 (View on PubMed)

Other Identifiers

UEuropeaValencia

Identifier Type: -

Identifier Source: org_study_id