Other Clinical Trial - Formulation-based CBT for Adult Inmates With ADHD:

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Attention Deficit Disorder with Hyperactivity
Attention Deficit Hyperactivity Disorder

Clinical Trial Details

NCT number	NCT06080373
Study type	Interventional
Source	Universidad Europea de Valencia
Contact	Carlos López-Pinar, Dr
Phone	+34 665878367
Email	carloslopez.pinar@universidadeuropea.es
Status	Not yet recruiting
Phase	N/A
Start date	September 2024
Completion date	September 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06129396` - Effects of Aerobic Exercise Intervention in Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)	N/A
Completed	`NCT04779333` - Lifestyle Enhancement for ADHD Program 2	N/A
Recruiting	`NCT05935722` - Evaluation of a Home-based Parenting Support Program: Parenting Young Children	N/A
Completed	`NCT03148782` - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase	N/A
Completed	`NCT04832737` - Strength-based Treatment Approach for Adults With ADHD	N/A
Recruiting	`NCT04631042` - Developing Brain, Impulsivity and Compulsivity
Recruiting	`NCT05048043` - Development of a Game-supported Intervention	N/A
Completed	`NCT03337646` - Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism	Phase 4
Completed	`NCT02911194` - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)	N/A
Completed	`NCT02477280` - Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance	Phase 4
Completed	`NCT02473185` - Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance During the QbTest	Phase 4
Completed	`NCT02829970` - Helping College Students With ADHD Lead Healthier Lifestyles	N/A
Completed	`NCT02555150` - A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD	Phase 3
Completed	`NCT02780102` - Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD	N/A
Completed	`NCT02390791` - New Technologies to Help Manage ADHD	N/A
Recruiting	`NCT04296604` - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations	N/A
Recruiting	`NCT04175028` - Neuromodulation of Executive Function in the ADHD Brain	N/A
Terminated	`NCT02259517` - An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD	N/A
Completed	`NCT02580890` - Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)	N/A
Completed	`NCT02251080` - Attention Deficit/Hyperactivity Disorder Internet Survey Study in a College Student Population	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms