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

Last updated: February 27, 2025
Sponsor: Instituto de Investigación Sanitaria Aragón
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

8-session UP condition

5-session UP condition

Clinical Study ID

NCT06547450
PID2023-151473OB-100
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Have at least one EDs diagnosis (anxiety, depressive, obsessive-compulsive, traumaand somatic disorders) from the ADIS-5 interview

  • Have a score between 0 and 5 severity (mild-moderate) on the diagnoses on the CSR ofthe ADIS-5

  • Be able to attend all assessment and treatment sessions

  • Individuals on pharmacological treatment will be asked to maintain the dosage forthe duration of the study, unless there is a medical contraindication

Exclusion

Exclusion Criteria:

  • Absence of clinical diagnosis

  • Presenting a diagnosis of EDs with a severity score on diagnoses between 6 and 8 onthe ADIS-5 CSR (severe) or a clinical condition requiring specialized mental healthintervention such as presence of severe mental disorder (e.g., personality disorder,bipolar disorder, or schizophrenia), suicide risk at the time of assessment, orsubstance use in the past three months

  • Who have received 8 or more sessions of CBT (during the past five years) withtechniques such as cognitive flexibility or exposure

  • Who are receiving psychological treatment.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: 8-session UP condition
Phase:
Study Start date:
May 10, 2025
Estimated Completion Date:
September 01, 2027

Study Description

Emotional disorders (EDs;including anxiety disorders, unipolar mood disorders, and related disorders) are the most prevalent mental disorders in the general population. In Spain, anxiety disorders and mood disorders affect approximately two million (4.1%) and two and half million (5.2%) individuals, respectively. As a result of their prevalence in the society, EDs have become an alarming health problem due to their associate costs. These disorders have a direct cost of 22.000 million euros (500 euros per capita and year). The total expense of these disorders entails 2.2% of the Gross Domestic Product in Spain.

In recent years, several alternatives have been proposed to address this situation, one of them being an increase in the number of clinical psychologists in our national health system (NHS) and, especially, their incorporation into primary care (PC) services.

It is considered that the incorporation of psychology in PC will help to reduce referral to specialized care because it will be possible to carry out a more exhaustive screening and determine which cases do not require psychological treatment, which cases should be referred to other health care resources and which cases can be treated in PC, usually mild-moderate TE. Another alternative to mitigate the excessive demand for care, regardless of the level of care, is the use of group psychological interventions, a cost-effective format for systems with limited resources such as our NHS.

Transdiagnostic interventions, like the Unified Protocol for the Treatment of EDs (UP), in brief group format, has emerged as a viable option for treating EDs in PC services.

The aim of the present study is to analyze the efficacy, cost-effectiveness and acceptability of the Unified Protocol for the transdiagnostic treatment of EDs, applied in 5 or 8 group sessions.

Furthermore, it will try to find out which characteristics of the participants (e.g., gender, clinical diagnoses, transdiagnostic dimensions affected, symptom severity) predict a better outcome (e.g., clinical improvement and quality of life) as a function of the sessions received. Thus, in the future, it will be possible to offer the optimal number of sessions according to specific profiles (personalization of treatments).

Connect with a study center

  • Centro de Salud Carinyena, Hospital Universitario de La Plana

    Villarreal, Comunidad Valenciana 12540
    Spain

    Site Not Available

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