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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

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Název: 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
Autoři: Carlos López-Pinar, Sonia Martínez-Sanchís, Enrique Carbonell-Vayà, Jose Martínez-Raga, Wolfgang Retz
Zdroj: Trials
ABACUS. Repositorio de Producción Científica
Universidad Europea (UEM)
r-FISABIO. Repositorio Institucional de Producción Científica
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Trials, Vol 25, Iss 1, Pp 1-12 (2024)
Informace o vydavateli: Springer Science and Business Media LLC, 2024.
Rok vydání: 2024
Témata: Adult, Male, Medicine (General), Time Factors, Inmates treatment, Psicología clínica, Waiting Lists, Prisión, Study Protocol, R5-920, ADHD, Cognitive behavioral therapy, Humans, Multicenter Studies as Topic, Psiquiatría, Randomized Controlled Trials as Topic, Cognitive Behavioral Therapy, Prisoners, 3. Good health, Treatment Outcome, Recidivism, Attention Deficit Disorder with Hyperactivity, Cognitive Behavioral Therapy/methods [MeSH], Prisoners/psychology [MeSH], Attention Deficit Disorder with Hyperactivity/psychology [MeSH], Adult [MeSH], Humans [MeSH], Treatment Outcome [MeSH], Formulation-based psychotherapy, Multicenter Studies as Topic [MeSH], Time Factors [MeSH], Randomized Controlled Trials as Topic [MeSH], Male [MeSH], Quality of Life [MeSH], Attention Deficit Disorder with Hyperactivity/therapy [MeSH], Waiting Lists [MeSH], Recidivism [MeSH], Quality of Life
Popis: 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. Trial registration ClinicalTrials.gov NCT06080373
Druh dokumentu: Article
Other literature type
ISSN: 1745-6215
DOI: 10.21203/rs.3.rs-3490908/v1
DOI: 10.1186/s13063-024-08434-w
Přístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/39243058
http://hdl.handle.net/11268/13084
https://fisabio.portalinvestigacion.com/publicaciones/17651
https://doaj.org/article/4533f15572d6459da9029228c3cd3492
https://hdl.handle.net/11268/13084
https://repository.publisso.de/resource/frl:6518753
Rights: CC BY
CC BY NC ND
Přístupové číslo: edsair.doi.dedup.....252a9dbb5bea26bd0dc70df1f731779a
Databáze: OpenAIRE
Popis
Abstrakt: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. Trial registration ClinicalTrials.gov NCT06080373
ISSN:17456215
DOI:10.21203/rs.3.rs-3490908/v1