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Recruiting NCT07070531

Unified Protocol in Penitentiary Facilities

Conditions: Depression Disorders, Anxiety, Mood Disorders, Emotional Disorder

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Instituto de Investigación Sanitaria Aragón

Location: Althaia Xarxa Assistencial Universitària de Manresa - Centre Penitenciari Lledoners Manresa Catalonia

Summary

Emotional disorders (EDs), which include anxiety disorders, unipolar mood disorders, and other related conditions, exhibit a high prevalence within prison populations, significantly exceeding that of the general population. Despite the high incidence of these disorders, the resources available for their treatment in correctional facilities are limited. The shortage of both human and material resources hinders inmates' access to quality mental health care. In this context, the Unified Protocol (UP) for the transdiagnostic treatment of emotional disorders, a transdiagnostic intervention grounded in Cognitive Behavioral Therapy, has demonstrated effectiveness in addressing a variety of psychological problems across different contexts. It has also proven to be cost-effective, particularly when delivered in a group format. Therefore, implementing the UP in group format within correctional settings could represent a viable strategy to optimize limited resources and provide accessible and effective treatment to a larger number of inmates. The primary objective of this pilot study is to evaluate the feasibility and clinical utility of the UP for the treatment of emotional disorders in prison environments. To this end, the UP will be delivered to approximately 25 participants, organized into groups of six to eight individuals, each receiving 12 weekly sessions lasting one hour. Follow-up assessments will be conducted at one, three, and six months after the intervention. A mixed-methods approach will be employed to analyze the results, combining quantitative analyses to assess changes in emotional symptomatology and qualitative analyses to explore participant satisfaction and therapist acceptance. It is expected that participants will experience statistically significant improvements in emotional symptoms and that these improvements will be sustained over time, up to the six-month follow-up. It is also anticipated that participants will report a high level of satisfaction with the treatment. Furthermore, therapists are expected to evaluate the intervention positively and to identify potential barriers to its implementation. The results of this pilot study will contribute to improving the feasibility and clinical utility of the UP in correctional settings, while also laying the groundwork for a future randomized controlled trial involving a larger number of facilities, participants, and therapists.

Eligibility Criteria

Inclusion Criteria: * At least one emotional disorder diagnosis (e.g., anxiety, depression, OCD, trauma-related, somatic, dissociative) based on the MINI interview * Comprehension of the intervention language (Spanish or Catalan) * Substance abstinence for more than 1 month * Voluntary participation and availability for all assessment and treatment sessions * Stable pharmacological treatment during the study unless medically contraindicated * Signed informed consent Exclusion Criteria: * No emotional disorder diagnosis * Cognitive impairment or IQ \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07070531). StuddyBuddy aggregates publicly available trial information.