Effectiveness of the Group Unified Protocol for Emotional Disorders in Adults in a Public Mental Health Setting

NCT07682064 | Recruiting

• 2 other identifiers: CEImLar P.I. 675CEImLar P.I.675
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This study has three primary objectives:

1. 1.To adapt the Spanish version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011, 2019a, 2019b) for delivery in a group format within the Spanish Public Mental Health System for adults diagnosed with emotional disorders.
2. 2.To evaluate the effectiveness of the intervention.
3. 3.To assess its clinical feasibility and acceptability in routine clinical practice.

Conditions

Emotional Disorders; ANXIETY DISORDERS (or Anxiety and Phobic Neuroses); Depressive Disorder; Somatic Disorders

Keywords

Unified Protocol; emotional disorder; UP; treatment

Outcome Measures

Primary Outcomes (3)

• Anxiety Symptoms

  Change in total score on the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006). The GAD-7 consists of seven items with total scores ranging from 0 to 21, where higher scores indicate greater anxiety symptom severity.

  Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

• Depressive Symptoms

  Change in total score on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The PHQ-9 includes nine items with total scores ranging from 0 to 27, where higher scores indicate greater depressive symptom severity.

  Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

• Somatic Symptoms

  Change in total score on the Patient Health Questionnaire-15 (PHQ-15; Kroenke et al., 2010). The PHQ-15 consists of fifteen items with total scores ranging from 0 to 30, where higher scores indicate greater somatic symptom severity.

  Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

Secondary Outcomes (6)

• Experiential avoidance

  Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

• Functional impairment

  Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

• Perceived quality of life

  Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

• Transdiagnostic dimensions

  Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

• Satisfaction with the program

  Immediately after completion of the 3-month intervention.

Study Arms (2)

3-month Unified Protocol + Treatment as Usual

EXPERIMENTAL

The UP (Barlow et al., 2011, 2019a, 2019b) is an emotion-focused, transdiagnostic cognitive-behavioral therapy for adults. Participants will receive a 9-session group-based adaptation of the UP, delivered in addition to treatment as usual (TAU). The program is designed for adults with emotional disorders receiving care within the Spanish Public Mental Health System.

Behavioral: UP

3-month Treatment as Usual

ACTIVE COMPARATOR

Participants assigned to the control group will receive treatment as usual (TAU) provided by the collaborating Public Mental Health Units. TAU will be delivered individually by the participant's assigned mental health professional and may include psychological and/or pharmacological treatment according to routine clinical practice.

Behavioral: TAU

Interventions

UP BEHAVIORAL

The UP includes eight modules designed to enhance emotion regulation skills: (1) Motivation Enhancement and Goal Setting; (2) Psychoeducation and Tracking Emotional Experiences; (3) Training in Present-Focused Emotional Awareness; (4) Cognitive Flexibility; (5) Countering Emotional Behaviors; (6) Understanding and Tolerating Physical Sensations; (7) Emotional Exposure; and (8) Recognizing Achievements and Maintaining Progress.

3-month Unified Protocol + Treatment as Usual

TAU BEHAVIORAL

TAU in the Public Mental Health Units of the La Rioja Health Service consists of care provided by specialists in Clinical Psychology and/or Psychiatry in accordance with routine clinical practice.

3-month Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 65 years.
• Ability and willingness to provide written informed consent.
• Sufficient proficiency in Spanish to participate in the intervention and complete study assessments.
• Sufficient cognitive capacity to understand the intervention content.
• A primary diagnosis of an emotional disorder with mild, moderate, or severe symptom severity, including Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive and Related Disorders, Trauma and Stressor-Related Disorders, Dissociative Disorders and Somatic Symptom and Related Disorders.
• Presence of emotional symptoms (e.g., anxiety, depressive, or phobic symptoms), somatic symptoms, obsessive symptoms, and/or avoidance behaviors associated with clinically significant impairment, as indicated by moderate or higher scores on the GAD-7, PHQ-9, and/or PHQ-15.

You may not qualify if:

• Refusal to provide informed consent or withdrawal of consent during the study.
• Current severe substance use disorder or behavioral addiction.
• Current high suicide risk.
• Current psychotic symptoms or psychotic disorder.
• Neurological disorders or severe medical conditions that could interfere with participation in or adherence to the intervention.
• Intellectual disability, significant language difficulties, or any other condition that may impair the participant's ability to understand the intervention content.

Sponsors & Collaborators

• Patricia Fernández Couto: lead
• University of La Rioja: collaborator

Study Sites (1)

Centro de Salud Espartero

Logroño, La Rioja, 26007, Spain

RECRUITING

Related Publications (10)

• Barlow, D. H., Farchione, T. J., Sauer-Zavala, S., Murray, H., Ellard, K., Bullis, J., & Bentley, K. H. (2019). Protocolo Unificado para el Tratamiento Transdiagnóstico de los Trastornos Emocionales (2nd ed.): Manual del terapeuta. Alianza Editorial. https://doi.org/10.1093/med:psych/9780199772667.001.0001

  BACKGROUND

• Barlow, D. H., Sauer-Zavala, S., Farchione, T. J., Murray, H., Ellard, K., Bullis, J., & Cassiello-Robbins, C. (2019). Protocolo Unificado para el Tratamiento Transdiagnóstico de los Trastornos Emocionales (2nd ed.): Manual del paciente. Alianza Editorial. https://doi.org/10.1093/med:psych/9780199772667.001.0001

  BACKGROUND

• Osma, J., Castellano, C., Crespo, E., & García-Palacios, A. (2015). The unified protocol for transdiagnostic treatment of emotional disorders in group format in a Spanish public mental health setting. Behavioral Psychology, 23(3), 447-466.

  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

• Garcia-Escalera J, Valiente RM, Sandin B, Ehrenreich-May J, Prieto A, Chorot P. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial. Behav Ther. 2020 May;51(3):461-473. doi: 10.1016/j.beth.2019.08.003. Epub 2019 Aug 14.

  PMID: 32402261 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

• Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.

  PMID: 22697453 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, D. H., Farchione, T. J., Fairholme, C. P., Ellard, K. K., Boisseau, C. L., Allen, L. B., & Ehrenreich-May, J. (2011). The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. Oxford University Press. https://doi.org/10.1093/med:psych/9780199772667.001.0001

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Phobic Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Patricia Fernández Couto, Clinical Psychologist

  Servicio Riojano de Salud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Fernández-Couto, Clinical Psychologist

CONTACT

(+34)941296251; pafernco@unirioja.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Psychology Specialist

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 2, 2026
• Study Start: April 27, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)