Unified Protocol in Penitentiary Facilities

Sponsor
Instituto de Investigación Sanitaria Aragón
Study ID
NCT07070531
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Depression Disorders
  • Emotional Disorder
  • Mood Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Unified Protocol — BEHAVIORAL
    The Unified Protocol (UP) is a transdiagnostic, emotion-focused cognitive-behavioral treatment designed to address a range of emotional disorders, including anxiety, depression, and related conditions. It targets core mechanisms such as emotional avoidance, cognitive rigidity, and maladaptive emotion regulation strategies. The UP consists of structured modules focused on increasing emotional awareness, cognitive flexibility, and exposure to emotionally evocative situations. By addressing common underlying processes across disorders, the UP enhances treatment efficiency and applicability in both individual and group formats. Its flexibility makes it suitable for diverse populations and settings, including community and clinical contexts.

Study Details

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.

Key Dates

First listed
Jul 17, 2025
Start date
Nov 1, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Unified Protocol in group format
    Participants will receive the intervention of the Unified Protocol (UP) in a group format, consisting of 12 sessions, one per week, each lasting 1 hour. Each session includes a review of previous content, resolution of doubts, and development of new material from one of eight modules. The program covers motivation for change, goal setting, understanding the adaptive function of emotions, emotional awareness and mindfulness, cognitive flexibility, problem solving, and addressing emotion-driven behaviors. Exposure to emotional and interoceptive experiences is introduced in later sessions. Follow-up sessions at 1, 3, and 6 months review progress, reinforce learning, identify risk signals, and promote relapse prevention and long-term well-being.

Primary Outcome Measure

Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5) [ Time Frame: Only before of the treatment to check inclusion criteria ]

Central Contacts

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