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Search / Trial NCT06547450

Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain

Launched by INSTITUTO DE INVESTIGACIÓN SANITARIA ARAGÓN · Aug 7, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Emotional Disorder Unified Protocol Primary Care Transdiagnostic Approach Group Format Brief Format

ClinConnect Summary

This clinical trial is studying a new way to treat emotional disorders like anxiety and depression in groups at primary care clinics in Spain. The goal is to see if a treatment called the Unified Protocol can effectively help people manage their emotions in just a few sessions, specifically focusing on its cost-effectiveness and how well patients accept it. Researchers want to find out if certain types of patients benefit more from the treatment compared to others and how it can be tailored to individual needs.

To participate, individuals must be diagnosed with a mild to moderate emotional disorder and be able to attend all sessions. Participants should not have severe mental health issues, and those who have received extensive cognitive behavioral therapy in the past or are currently undergoing psychological treatment are not eligible. If selected, participants can expect to join either 5 or 8 group sessions where they will learn skills to help manage their emotional disorders. The findings from this study may help improve mental health care in the Spanish public health system.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Have at least one EDs diagnosis (anxiety, depressive, obsessive-compulsive, trauma and somatic disorders) from the ADIS-5 interview
  • Have a score between 0 and 5 severity (mild-moderate) on the diagnoses on the CSR of the ADIS-5
  • Be able to attend all assessment and treatment sessions
  • Individuals on pharmacological treatment will be asked to maintain the dosage for the duration of the study, unless there is a medical contraindication
  • Exclusion Criteria:
  • Absence of clinical diagnosis
  • Presenting a diagnosis of EDs with a severity score on diagnoses between 6 and 8 on the ADIS-5 CSR (severe) or a clinical condition requiring specialized mental health intervention such as presence of severe mental disorder (e.g., personality disorder, bipolar disorder, or schizophrenia), suicide risk at the time of assessment, or substance use in the past three months
  • Who have received 8 or more sessions of CBT (during the past five years) with techniques such as cognitive flexibility or exposure
  • Who are receiving psychological treatment.

About Instituto De Investigación Sanitaria Aragón

Instituto de Investigación Sanitaria Aragón (IIS Aragón) is a leading clinical research organization dedicated to advancing healthcare through innovative research and collaboration. Based in Spain, IIS Aragón focuses on translational medicine, bridging the gap between laboratory discoveries and clinical applications. The institute fosters a multidisciplinary approach, bringing together experts from various fields to enhance the quality and efficiency of clinical trials. With a commitment to ethical standards and patient safety, IIS Aragón plays a pivotal role in driving scientific advancements and improving health outcomes in the region and beyond.

Locations

Villarreal, Comunidad Valenciana, Spain

Patients applied

0 patients applied

Trial Officials

Jorge Osma, Ph.D

Principal Investigator

Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported