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ArticleTrials2024

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.

Carlos López-Pinar, Sonia Martínez-Sanchís, Enrique Carbonell-Vayà, Jose Martínez-Raga, Wolfgang Retz

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06080373 (Formulation-Based Cognitive-Behavioral Therapy Compared to an Active Control and a Waitlist in Adult Inmates With ADHD), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06080373 nanot yet recruitingnot on this mapstarted 2027, after this paper: background citation

Formulation-Based Cognitive-Behavioral Therapy Compared to an Active Control and a Waitlist in Adult Inmates With ADHD: A Randomized Controlled Trial

TypeinterventionalSponsorUniversidad Europea de ValenciaRan2027 to 2029Enrolled111ConditionsAttention Deficit Hyperactivity DisorderArmsPROBECO, Formulation-based cognitive behavioral therapy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Carlos López-PinarDepartment of Psychology, European University of Valencia, Valencia, Spain. carloslopez.pinar@universidadeuropea.es.ORCID http://orcid.org/0000-0002-0982-5581
Sonia Martínez-SanchísDepartment of Psychobiology, University of Valencia, Valencia, Spain.
Enrique Carbonell-VayàDepartment of Basic Psychology, University of Valencia, Valencia, Spain.
Jose Martínez-RagaPsychiatry Department. University Hospital Doctor Peset & Department of Medicine, University of Valencia, Valencia, Spain.
Wolfgang RetzInstitute for Forensic Psychology and Psychiatry, Faculty of Medicine, Saarland University, Homburg, Saar, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent 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.

methodsThe 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.

trial registrationClinicalTrials.gov NCT06080373. Registered on October 12, 2023.

Indexed as

Attention Deficit Disorder with HyperactivityCognitive Behavioral TherapyMulticenter Studies as TopicPrisonersRandomized Controlled Trials as TopicAdultHumansMaleQuality of LifeRecidivismTime FactorsTreatment OutcomeWaiting ListsADHD; Cognitive behavioral therapyFormulation-based psychotherapyInmates treatment

Identifiers

PMID39243058
PMCPMC11380400

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.