NCT07682064 Effectiveness of the Group Unified Protocol for Emotional Disorders in Adults in a Public Mental Health Setting
| NCT ID | NCT07682064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Patricia Fernández Couto |
| Condition | Emotional Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2024-04-27 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2024-04-27 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Patricia Fernández Couto, Clinical Psychologist
PRINCIPAL INVESTIGATOR
Servicio Riojano de Salud
Frequently Asked Questions
Who can join the NCT07682064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Emotional Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07682064 currently recruiting?
Yes, NCT07682064 is actively recruiting participants. Contact the research team at pafernco@unirioja.es for enrollment information.
Where is the NCT07682064 trial being conducted?
This trial is being conducted at Logroño, Spain.
Who is sponsoring the NCT07682064 clinical trial?
NCT07682064 is sponsored by Patricia Fernández Couto. The principal investigator is Patricia Fernández Couto, Clinical Psychologist at Servicio Riojano de Salud. The trial plans to enroll 106 participants.