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

Official title

Effectiveness of the Group Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al. 2011, 2019a, 2019b) in Adults in a Public Mental Health Setting

Overview

This study has three primary objectives: 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. To evaluate the effectiveness of the intervention. 3. To assess its clinical feasibility and acceptability in routine clinical practice. Outcomes will include anxiety, depression, somatic symptoms, transdiagnostic variables, functional impairment, quality of life, and participant satisfaction. These outcomes will be assessed at baseline, post-treatment, and 3-month follow-up. The intervention is expected to improve emotional symptoms, functional impairment, and quality of life. In addition, the study will explore whether this group-based transdiagnostic approach may help lower demand on public mental health services.

Detailed description

Anxiety and depressive disorders are among the leading causes of disability and contributors to the global burden of disease worldwide. To address this public health challenge, stepped-care models have been developed to organize treatment according to patients' clinical needs and progression. Within this framework, the transdiagnostic approach proposes that emotional disorders share common underlying transdiagnostic mechanisms, including elevated negative affect and maladaptive emotion regulation strategies such as emotional avoidance.

Accordingly, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) has emerged as an evidence-based intervention for anxiety, depressive, and related emotional disorders. The UP aims to enhance adaptive emotion regulation and lower maladaptive behavioral avoidance, thereby promoting improvements across a broad range of emotional symptoms.

This study aims to adapt and implement the Spanish version of the UP in a group format for adults diagnosed with an emotional disorder receiving treatment within the Spanish Public Mental Health System. In addition, the study will evaluate the intervention's effectiveness, feasibility, acceptability, and cost-effectiveness. The intervention will be delivered in Public Mental Health Units of the La Rioja Health Service.

Adults aged 18 to 65 years diagnosed with an emotional disorder will be recruited. The study will employ a randomized controlled trial design with two parallel groups: a Treatment as Usual (TAU) group and an experimental group (UP + TAU). Assessments will be conducted at pre-treatment, post-treatment, and 3-month follow-up. Outcome measures will assess anxiety, depression, somatic symptoms, transdiagnostic processes, functional impairment, quality of life, participant satisfaction, and intervention cost-effectiveness.

Interventions

• Behavioral UP
  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.
• Behavioral TAU
  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.

Primary outcome measures

• Anxiety Symptoms [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]
• Depressive Symptoms [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]
• Somatic Symptoms [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]

Secondary outcome measures (6)

• Experiential avoidance [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]
• Functional impairment [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]
• Perceived quality of life [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]
• Transdiagnostic dimensions [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]
• Satisfaction with the program [Time frame: Immediately after completion of the 3-month intervention.]
• Use of healthcare resources [Time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Centro de Salud Espartero — Logroño

Publications

• 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
• 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
• 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.
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07682064 · CEImLar P.I. 675 · CEImLar P.I.675

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗