Blended intervention for treating emotional disorders in Spain
Implementation, Effficacy and Cost-effective Study of the Unified Protocol in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System
This study is testing a new combined treatment for anxiety and depression to see if it works better than regular therapy for people in Spain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigación Sanitaria Aragón Academic / other |
| Locations | 1 site (Vinaròs, Comunidad Valenciana) |
| Trial ID | NCT04304911 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled trial aims to evaluate the efficacy, cost-effectiveness, and implementation characteristics of a blended intervention based on the Unified Protocol for the transdiagnostic treatment of emotional disorders compared to standard treatment. Emotional disorders, including anxiety and depressive disorders, are highly prevalent in Spain, affecting millions and imposing significant costs on the healthcare system. The study seeks to address the overwhelming demand for mental health services by exploring innovative treatment solutions within the Spanish National Health System. Participants will receive either the blended intervention or traditional Cognitive Behavioral Therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a principal diagnosis of an emotional disorder who are fluent in Spanish and possess a smartphone.
Not a fit: Patients with severe mental disorders, those at risk of suicide, or individuals who have received extensive prior psychological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and accessible treatment option for patients suffering from emotional disorders.
How similar studies have performed: Other studies have shown promise with blended interventions for mental health treatment, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Principal diagnosis of Emotional disorder (Evaluated by MINI interview) * The patient is over 18 years of age * The patient is fluent in the language in which the therapy is performed (Spanish in the present study) * To have a Smartphone * Patients taking pharmacological treatment for their ED will be asked to maintain the same dosages and medications for at least 3 months prior to enrolling in the study and during the whole treatment * The patient signs the informed consent form. Exclusion Criteria: * The patient presents a severe condition that would require to be prioritized for treatment, these include a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months * The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable Cognitive behavioral therapy (CBT) principles within the past 5 years.
Where this trial is running
Vinaròs, Comunidad Valenciana
- Hospital Comarcal de Vinaròs — Vinaròs, Comunidad Valenciana, Spain (Recruiting)
Study contacts
- Principal investigator: Jorge Osma, Ph.D — Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza
- Study coordinator: Jorge Osma, Ph.D
- Email: osma@unizar.es
- Phone: 978645390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.