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Randomized Controlled Trial
. 2018 Mar 12;16(1):46.
doi: 10.1186/s12955-018-0866-2.

Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial

Jorge Osma  1   2   3 , Carlos Suso-Ribera  4 , Azucena García-Palacios  5 , Elena Crespo-Delgado  4 , Cristina Robert-Flor  6 , Ana Sánchez-Guerrero  6 , Vanesa Ferreres-Galan  7 , Luisa Pérez-Ayerra  8 , Amparo Malea-Fernández  9 , Mª Ángeles Torres-Alfosea  10
Affiliations
Randomized Controlled Trial

Efficacy of the unified protocol for the treatment of emotional disorders in the Spanish public mental health system using a group format: study protocol for a multicenter, randomized, non-inferiority controlled trial

Jorge Osma et al. Health Qual Life Outcomes. .

Abstract

Background: Emotional disorders, which include both anxiety and depressive disorders, are the most prevalent psychological disorders according to recent epidemiological studies. Consequently, public costs associated with their treatment have become a matter of concern for public health systems, which face long waiting lists. Because of their high prevalence in the population, finding an effective treatment for emotional disorders has become a key goal of today's clinical psychology. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders might serve the aforementioned purpose, as it can be applied to a variety of disorders simultaneously and it can be easily performed in a group format.

Methods: The study is a multicenter, randomized, non-inferiority controlled clinical trial. Participants will be 220 individuals with emotional disorders, who are randomized to either a treatment as usual (individual cognitive behavioral therapy) or to a Unified Protocol condition in group format. Depression, anxiety, and diagnostic criteria are the primary outcome measures. Secondary measures include the assessment of positive and negative affect, anxiety control, personality traits, overall adjustment, and quality of life. An analysis of treatment satisfaction is also conducted. Assessment points include baseline, post-treatment, and three follow-ups at 3, 6, and 12 months. To control for missing data and possible biases, intention-to-treat and per-protocol analyses will be performed.

Discussion: This is the first randomized, controlled clinical trial to test the effectiveness of a transdiagnostic intervention in a group format for the treatment of emotional disorders in public settings in Spain. Results obtained from this study may have important clinical, social, and economic implications for public mental health settings in Spain.

Trial registration: Retrospectively registered at https://clinicaltrials.gov/ . Trial NCT03064477 (March 10, 2017). The trial is active and recruitment is ongoing. Recruitment is expected to finish by January 2020.

Keywords: Controlled trial; Emotional disorders; Group therapy; Multicenter; Public mental health; Randomized; Transdiagnostic; Unified protocol.

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Conflict of interest statement

Authors’ information

J.O. is an Associate professor and Director of the General Health Psychology Master at the Psychology and Sociology Department of the University of Zaragoza. He is the PI of this project and an effective member of the “Psychological research and technological tools” (INPAT) research group (S-116 Aragon Government) and the Instituto de Investigación Sanitaria de Aragón. C.S.R. is a Postdoctoral researcher at the Department of Basic and Clinical Psychology and Psychobiology of the Universitat Jaume I. A.G.P. is Full professor of Psychopathology at the Department of Basic and Clinical Psychology and Psychobiology of the Universitat Jaume I. E.C.D. is an Assistant professor at the Department of Basic and Clinical Psychology and Psychobiology of the Universitat Jaume I. C.R.F. and A.S.G. are Clinical Psychologists at the La Fuente de San Luís Mental Health Unit in Valencia. V.F.G. is a Clinical Psychologist at the Hospital Comarcal de Vinaròs in Castellón. L.P.A. is a Clinical Pshychologist at the Centro de Salud Mental La Milagrosa in Pamplona. A.M.F. is a Clinical Pshychologist at the La Malvarrosa Mental Health Center in Valencia. M.A.T.A. is a Clinical Pshychologist at the Hospital General Universitario de Alicante.

Ethics approval and consent to participate

The study have been performed in accordance with the Declaration of Helsinki and have been approved and registered by the ethical and research committees from the following collaborating centers: Hospital General Clínico de Elda (PUG-02-14), Hospital Clínico Universitario de Valencia (F-CE-GEva-15), Hospital Universitario Dr. Peset (CEIC 53/15), CSM IIA Milagrosa (Pyto2016/41), and Hospital Comarcal de Vinaròs (0103–2016).In addition, the protocol study have been registered retrospectively at https://clinicaltrials.gov/. Trials on March 10, 2017 (NCT03064477).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Study schedule of enrolment, interventions, and assessments
See this image and copyright information in PMC

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