Unified Protocol in Penitentiary Facilities

NCT07070531 | Not Yet Recruiting

• 1 other identifier: IPES/PU-CP/2025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Disorders; Anxiety; Mood Disorders; Emotional Disorder

Keywords

Unified Protocol; Transdiagnostic Intervention; Incarcerated Population; Correctional Facilities; Group Therapy; Cognitive-behavioral Therapy; Emotional Disorders

Outcome Measures

Primary Outcomes (4)

• Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5)

  Diagnostic interview to determine if the participant has a clinical diagnosis of emotional disorder (ET) and can be part of the study. The following diagnoses according to the DSM-V are included within the category of emotional disorder: major depressive disorder, dysthymic disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, post-traumatic stress disorder, social anxiety disorder, hypochondria, and adjustment disorders. Patients with anxiety disorders not otherwise specified and those with depressive disorders not otherwise specified will also be included in the study.

  Only before of the treatment to check inclusion criteria

• General Depression Severity and Interference Scale (ODSIS)

  Severity of depressive symptoms; 5 items with 5-point Likert scale ranging from 0 (I did not feel depressed) to 4 (constant depression). Higher scores are associated with greater depressive symptomatology and interference.

  Up to 6 months follow-up

• General Severity and Interference Scale for Anxiety (OASIS)

  Severity of anxiety symptoms; 5 items with 5-point Likert scale ranging from 0 (I did not feel anxious) to 4 (constant anxiety). Higher scores are associated with greater anxiety symptomatology and interference.

  Up to 6 months follow-up

• Multidimensional Inventory for Emotional Disorders (MEDI)

  Evaluation through 49 items of the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance

  Up to 6 months follow-up

Secondary Outcomes (4)

• Emotional Regulation Difficulties Scale (DERS)

  Up to 6 months follow-up

• EuroQol

  Up to 6 months follow-up

• The EuroQol Visual Analog Scale (VAS)

  Up to 6 months follow-up

• Satisfaction with Treatment Questionnaire (STQ) An adaptation of Client Satisfaction Questionnaire (CSQ-8)

  Up to 6 months follow-up

Other Outcomes (5)

• Questionnaire on Sociodemographic Data (ad hoc)

  Baseline

• Acceptability Questionnaire based on the TFA model

  At the end of treatment (at 3 months)

• Questionnaire on Intention to Use the UP in the Future and General Acceptability

  At the end of treatment (at 3 months)

Study Arms (1)

Unified Protocol in group format

EXPERIMENTAL

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.

Behavioral: Unified Protocol

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.

Unified Protocol in group format

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No emotional disorder diagnosis
• Cognitive impairment or IQ \<70 preventing comprehension
• Diagnosis of a mental disorder incompatible with group formats (e.g., histrionic personality disorder)
• Suicide risk at assessment
• Legal status involving potential release or leave that could affect adherence

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Universidad de Zaragoza

Teruel, Teruel, 44003, Spain

Location

Related Publications (10)

• Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.

  PMID: 10158943 BACKGROUND

• Osma J, Martinez-Loredo V, Quilez-Orden A, Peris-Baquero O, Ferreres-Galan V, Prado-Abril J, Torres-Alfosea MA, Rosellini AJ. Multidimensional emotional disorders inventory: Reliability and validity in a Spanish clinical sample. J Affect Disord. 2023 Jan 1;320:65-73. doi: 10.1016/j.jad.2022.09.140. Epub 2022 Sep 29.

  PMID: 36183816 BACKGROUND

• Osma J, Quilez-Orden A, Suso-Ribera C, Peris-Baquero O, Norman SB, Bentley KH, Sauer-Zavala S. Psychometric properties and validation of the Spanish versions of the overall anxiety and depression severity and impairment scales. J Affect Disord. 2019 Jun 1;252:9-18. doi: 10.1016/j.jad.2019.03.063. Epub 2019 Mar 29.

  PMID: 30953927 BACKGROUND

• Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.

  PMID: 24708078 BACKGROUND

• Peris-Baquero O, Osma J, Gil-LaCruz M, Martinez-Garcia L. Acceptability of and intention to use the Unified Protocol delivered in group format in the Spanish Public Health System. J Eval Clin Pract. 2021 Dec;27(6):1299-1309. doi: 10.1111/jep.13546. Epub 2021 Feb 9.

  PMID: 33565231 BACKGROUND

• Osma J, Peris-Baquero O, Suso-Ribera C, Farchione TJ, Barlow DH. Effectiveness of the Unified Protocol for transdiagnostic treatment of emotional disorders in group format in Spain: Results from a randomized controlled trial with 6-months follow-up. Psychother Res. 2022 Mar;32(3):329-342. doi: 10.1080/10503307.2021.1939190. Epub 2021 Jun 16.

  PMID: 34132170 BACKGROUND

• Barlow DH, Harris BA, Eustis EH, Farchione TJ. The unified protocol for transdiagnostic treatment of emotional disorders. World Psychiatry. 2020 Jun;19(2):245-246. doi: 10.1002/wps.20748. No abstract available.

  PMID: 32394551 BACKGROUND

• Sakiris N, Berle D. A systematic review and meta-analysis of the Unified Protocol as a transdiagnostic emotion regulation based intervention. Clin Psychol Rev. 2019 Aug;72:101751. doi: 10.1016/j.cpr.2019.101751. Epub 2019 Jun 25.

  PMID: 31271848 BACKGROUND

• Cassiello-Robbins C, Southward MW, Tirpak JW, Sauer-Zavala S. A systematic review of Unified Protocol applications with adult populations: Facilitating widespread dissemination via adaptability. Clin Psychol Rev. 2020 Jun;78:101852. doi: 10.1016/j.cpr.2020.101852. Epub 2020 Apr 20.

  PMID: 32360953 BACKGROUND

• Carlucci L, Saggino A, Balsamo M. On the efficacy of the unified protocol for transdiagnostic treatment of emotional disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Jul;87:101999. doi: 10.1016/j.cpr.2021.101999. Epub 2021 Mar 9.

  PMID: 34098412 BACKGROUND

Related Links

• IPES web (Investigation group)

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Óscar Peris Baquero, Phd

CONTACT

978645386; operis@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The recruitment process for this study will be conducted within the participating correctional facilities: Brians 1, Brians 2, Quatre Camins, and Lledoners (Barcelona). Inmates who are evaluated in the specialized Mental Health care service at the correctional facility and who have at least one diagnosis of a mental health disorder (TE) will be offered the opportunity to participate. The selection process will be based on the clinical evaluation carried out by the mental health professionals, who will inform the inmates about the possibility of participating in the study and offer them the chance to join, provided they meet the inclusion criteria and give their informed consent.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: July 17, 2025
• Study Start: November 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)