5-session UP condition: Unified Protocol (UP) for transdiagnostic treatment of EDs in 5-session
8-session UP condition: Unified Protocol (UP) for transdiagnostic treatment of EDs in 8-session
Study summary
The aim of this project is to contribute to the improvement of psychological care received in primary care (PC), through the study of the cost-effectiveness and acceptability of the Unified Protocol for the treatment of emotional disorders in brief groups in primary care services in Spain (PU-AP) for the treatment of emotional disorders (EDs), the most prevalent in our society. To do so, a pilot study will be carried out, and, subsequently, a randomized clinical trial to study the efficacy, cost-effectiveness and acceptability of the Unified Protocol for the transdiagnostic treatment of EDs, applied in 5 or 8 group sessions. Finally, the researchers will analyze whether there are specific patient profiles that will benefit more from one or the other condition. The results will contribute to the personalization of the psychological treatment of users with EDs attending PC in the Spanish public health system.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V) — Enrollment and Up to 6 months Diagnostic interview
Diagnostic interview
Overall Depression Severity and Impairment Scale (ODSIS) — Up to 6 months Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4.
Overall Anxiety Severity and Impairment Scale (OASIS) — Up to 6 months The scale presents five items. These items are related with the frequency and intensity of anxiety symptoms and their interference with the person's work or school life and with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety).
Health-related quality of life (EuroQol-5D) — Up to 6 months Evaluation through 5 items of quality of life. For this study, the visual analog scale (EQ-VAS) was used, using a score from 0 to 100 (0 = worst imaginable state of health; 100 = best imaginable state of health).
Difficulties in Emotion Regulation Scale (DERS) — Up to 6 months Consists of 36-item of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Higher scores indicate more difficulty in emotion regulation
Trial sites (1)
Facility
City
Region
Status
Centro de Salud Carinyena, Hospital Universitario de La Plana
Villarreal
Valencia
More Instituto de Investigación Sanitaria Aragón trials in Spain
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.
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