Formulation-based CBT for Adult Inmates With ADHD: A Randomized Controlled Trial - Trial NCT06080373
Access comprehensive clinical trial information for NCT06080373 through Pure Global AI's free database. This phase not specified trial is sponsored by Universidad Europea de Valencia and is currently Not yet recruiting. The study focuses on Attention Deficit Hyperactivity Disorder. Target enrollment is 111 participants.
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Study Focus
Sponsor & Location
Universidad Europea de Valencia
Timeline & Enrollment
N/A
Sep 01, 2024
Sep 01, 2026
Primary Outcome
Conners Adult ADHD Diagnostic Interview for DSM-IV (CAADID),Reoffending rate
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06080373
Non-Device Trial