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NCT Number: NCT07682064

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud Espartero

Logroño, La Rioja, 26007, Spain

Location status: Recruiting

Location contact

Patricia Fernández Couto

CONTACT

[email protected]

(+34)941296251 ext. 80324

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Anxiety Symptoms

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

    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.

  2. Depressive Symptoms

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

    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.

  3. Somatic Symptoms

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

    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.

Secondary outcomes

  1. Experiential avoidance

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

    Change in total score on the Acceptance and Action Questionnaire-II (AAQ-II; Ruiz et al., 2013). The AAQ-II includes seven items with total scores ranging from 7 to 42, where higher scores reflect greater experiential avoidance.

  2. Functional impairment

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

    Change in total score on the Inadaptation Scale (EI; Echeburúa et al., 2000). The EI consists of six items with total scores ranging from 0 to 30, where higher scores indicate greater functional impairment.

  3. Perceived quality of life

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

    Change in total and domain scores on the WHO Quality of Life-BREF (WHOQOL-BREF; Lucas-Carrasco, 2012). The WHOQOL-BREF includes 26 items across multiple domains, with item scores ranging from 1 to 5. Higher scores indicate better perceived quality of life.

  4. Transdiagnostic dimensions

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

    Change in scores across domains on the Multidimensional Emotional Disorder Inventory (MEDI; Rosellini & Brown, 2019). The MEDI includes 49 items rated from 0 to 8, grouped into nine domains. Higher scores indicate greater severity of transdiagnostic emotional disorder dimensions.

  5. Satisfaction with the program

    Time frame: Immediately after completion of the 3-month intervention.

    Participant satisfaction will be assessed post-intervention using a 10-item questionnaire adapted from García-Escalera et al. (2020). Each item is rated on a 5-point Likert scale ranging from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater satisfaction. Some items are reverse coded prior to score calculation.

  6. Use of healthcare resources

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

    Composite measure of healthcare utilization, including number of visits to healthcare services, missed treatment sessions, and number of medical tests performed.

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Fernández-Couto, Clinical Psychologist

CONTACT

[email protected]

(+34)941296251 ext. 80324

Sponsors and collaborators

Lead sponsor

Patricia Fernández Couto

Other

Collaborators

  • University of La Rioja

Registry information

Official study 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

Acronym: PSIGTE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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