Clinical trial NCT06080373: Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial
Official title: Formulation-Based Cognitive-Behavioral Therapy Compared to an Active Control and a Waitlist in Adult Inmates With ADHD: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Universidad Europea de Valencia
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID)
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
measure: Reoffending rate
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Secondary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
measure: Attention-deficit/hyperactivity rating scale-IV
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
measure: Rosenberg self-esteem scale (RSES
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
measure: Adult ADHD Quality of Life Questionnaire (AAQoL
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
measure: Maudsley Addiction Profile (MAP)
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
measure: Beck depression inventory-II (BDI-II) and Beck anxiety inventory (BAI)
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
measure: Historical Clinical Risk Management-20 (HCR-20)
timeFrame: Pre and post-treatment plus follow-up assessments 6 and 12 months after the end of the intervention
Other outcomes:
measure: Treatment adherence
timeFrame: During the intervention
Locations:
Study officials:
affiliation: Universidad Europea de Valencia
name: Carlos López-Pinar, Dr
role: PRINCIPAL_INVESTIGATOR
References: