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

Официальное название

Study of the Cost-efficacy and Acceptability of the Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain (PU-AP)

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 5-session UP condition
  Unified Protocol (UP) for transdiagnostic treatment of EDs in 5-session
• Поведенческое 8-session UP condition
  Unified Protocol (UP) for transdiagnostic treatment of EDs in 8-session

Первичные конечные точки

• Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V) [Срок оценки: Enrollment and Up to 6 months]
• Overall Depression Severity and Impairment Scale (ODSIS) [Срок оценки: Up to 6 months]
• Overall Anxiety Severity and Impairment Scale (OASIS) [Срок оценки: Up to 6 months]
• Health-related quality of life (EuroQol-5D) [Срок оценки: Up to 6 months]
• Difficulties in Emotion Regulation Scale (DERS) [Срок оценки: Up to 6 months]

Вторичные конечные точки (7)

• The Multidimensional Emotional Disorder Inventory (MEDI) [Срок оценки: Up to 6 months]
• Five Facet Mindfulness Questionnaire (FFMQ) [Срок оценки: Up to 6 months]
• Working Alliance Inventory-Short (WAI-S) [Срок оценки: Up to 6 months]
• Maladjustment Scale (MI) [Срок оценки: Up to 6 months]
• Positive and negative affect scale [Срок оценки: Up to 6 months]
• Adaptation of Client Satisfaction Questionnaire [CSQ-8] [Срок оценки: Up to 6 months]
• Quality-adjusted Life Years (QALYs) [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Centro de Salud Carinyena, Hospital Universitario de La Plana — Villarreal

Публикации

• Barlow DH, Harris BA, Eustis EH, Farchione TJ. The unified protocol for transdiagnostic treatment of emotional disorders. World Psychiatry. 2020 Jun;19(2):245-246. doi: 10.1002/wps.20748. No abstract available. PMID 32394551
• Osma J, Sanchez-Albentosa M, Prieto-Rollan I, Fadrique-Jimenez A, Navarro-Haro MV, Peris-Baquero O. Cost-effectiveness and acceptability study of the Unified Protocol for the treatment of emotional disorders in brief groups in primary care services of the Spanish National Health System: a study protocol. BMC Prim Care. 2026 May 2;27(1):243. doi: 10.1186/s12875-026-03347-w. PMID 42067774
• Peris-Baquero O, Fadrique-Jimenez A, Prieto-Rollan I, Camacho-Guerrero L, Martinez-Lluesma S, Osma J. Brief Versions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Spanish Primary Care Service: Results of a Feasibility Pilot Study. J Clin Psychol. 2025 Nov;81(11):1103-1117. doi: 10.1002/jclp.70016. Epub 2025 Jul 16. PMID 40667676

Идентификаторы

NCT: NCT06547450 · PID2023-151473OB-100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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