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Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07070531). This is a study registration, not published results. Lead sponsor: Instituto de Investigación Sanitaria Aragón. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 25 participants (ESTIMATED). Conditions: Depression Disorders, Anxiety, Mood Disorders, Emotional Disorder. Interventions: BEHAVIORAL: Unified Protocol. Primary outcome measures: Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5) , Only before of the treatment to check inclusion criteria; General Depression Severity and Interference Scale (ODSIS) , Up to 6 months follow-up; General Severity and Interference Scale for Anxiety (OASIS) , Up to 6 months follow-up; Multidimensional Inventory for Emotional Disorders (MEDI) , Up to 6 months follow-up. Brief 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.