Emotional DisordersANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Depressive DisorderSomatic Disorders
Investigational drug(s) / intervention(s)
UPTAU
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.
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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Anxiety Symptoms — 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.
Depressive Symptoms — 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.
Somatic Symptoms — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
