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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPatricia Fernández Couto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: 3-month Unified Protocol + Treatment as UsualExperimental treatment 1 intervention
Group B: 3-month Treatment as UsualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
2

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.

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

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.

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

Secondary outcomes

1

Experiential avoidance

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.

Time frame
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
2

Functional impairment

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.

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

Perceived quality of life

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.

Time frame
Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.
4

Transdiagnostic dimensions

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.

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

Other outcomes

Sponsors and contacts

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Patricia Fernández Couto

Lead sponsor

University of La Rioja

Sponsor institution

University of La Rioja

Collaborator