The Unified Protocol for the Treatment of Emotional Disorders in Spanish Public Mental Health System

NCT ID: NCT03064477

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-14
• Study Completion Date: 2021-12-30

Brief Summary

The present randomized, controlled trial will compare the cost-efficacy and acceptability of the Unified Protocol in group format against traditional individual Cognitive Behavioral Treatment in a sample of patients with emotional disorders. Ultimately, the goal of the current study is to explore whether the Unified Protocol in group format can be a cost-effective psychological intervention for emotional disorders in the Spanish National Health System, that is, one that generates long-lasting changes in symptoms, while reducing both direct and indirect economic costs associated with the treatment of emotional disorders.

Detailed Description

Emotional disorders (EDs; i.e., depressive and anxiety disorders) have become the most prevalent psychiatric disorders globally. The 12-month prevalence of anxiety and depressive disorders affect 14% and 7.8% (6.9% by major depression) of the population, respectively, and comordibity may be as high as 50%. Lifetime prevalence rates in primary care settings in Spain reveal that mood and anxiety disorders, as defined in the DSM-IV-TR, are the most prevalent psychiatric problems as well, with 35.8% and 25.6%, respectively.

As a result of their high prevalence in the population, emotional disorders have become a global health problem due to their associated costs.For instance, a study conducted in 36 countries estimated that the annual cost of treatment for depressive disorders and anxiety problems amounted to $91 billion and $56 billion, respectively. If both direct and indirect costs of these emotional disorders were accounted for, expenses increased to $925,000 million. In Spain, when both direct and indirect costs are included, mood and anxiety disorders are estimated to cost €10,763 million and €10,365 million, respectively.

Pharmacological treatment and individual cognitive behavioral therapy (CBT) are the most frequent interventions for emotional disorders in the Spanish National Health System. Therefore, increasing the efficiency of these treatments may be a way of reducing the current public health costs of emotional disorders. A recently developed form of CBT, the Unified Protocol for the Treatment of Emotional Disorders (UP), 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. The UP was created on the basis of the identification of common psychopathological vulnerability factors in emotional disorders, together with elements and techniques shared by disorder-specific cognitive-behavioral treatments. In the UP, traditional CBT techniques (i.e., cognitive restructuring) and contemporary practices (i.e., mindfulness) are combined to treat emotion regulation deficits, which are argued to be the underlying common factor in all emotional disorders. The UP is a structured, manual-based treatment, so it can be easily applied in a group format. This, together with the fact that the UP can be applied simultaneously to individuals with different emotional disorders, might help reduce existent waiting lists and current costs of individual treatment.

So far, studies exploring the effectiveness of the UP in a group format have led to promising findings. Overall, results suggest that the UP has between moderate and strong effect sizes on numerous outcomes, including depression, anxiety, positive and negative affect, quality of life, overall adjustment, and avoidance of negative sensations, for both anxiety and mood disorders. These studies have also revealed that between half and two thirds of patients ceased to meet diagnostic criteria after the treatment and one investigation, conducted by the investigators participating in the present study, revealed that changes remained stable 12 months after treatment completion. Despite the previous results are encouraging, conclusions should be interpreted with caution as sample sizes have been small (11 participants in two studies and 47 patients in one investigation) and cost-effectiveness of the UP in group format compared with traditional individual CBT remains unclear. Methodologically-sound, randomized, controlled trials are needed in order to replicate the aforementioned findings and to elucidate whether the UP in group format is an effective and efficient treatment option for emotional disorders in public settings.

It is expected that both interventions (CBT and UP) will be comparable in terms of effectiveness and acceptability, but treatment costs will be lower in the UP condition. To ensure the generalizability of results, the hypotheses will be tested in various public mental health centers in Spain.

Conditions

Emotional Disorder; Anxiety Disorders; Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unified Protocol (UP)

Investigators in the present study have adapted the UP to implement it in group format in a Public Mental Health setting in Spain. This adaptation is composed of 12 treatment sessions of two hours of duration each, at a rate of one per week.

Participants in the UP will receive UP treatment in group format instead of the usual Cognitive Behavioral Therapy in individual format. Patients in the UP condition will receive pharmacological treatment (i.e., antidepressants and / or anxiolytics) as usual.

Group Type: EXPERIMENTAL

Unified Protocol

Intervention Type: BEHAVIORAL

Intervention group that carries out the Unified Protocol in a group format

Treatment As Usual (TAU)

Cognitive Behavioral Therapy in individual format is the treatment of choice (TAU) by psychologists and psychiatrists at the collaborating Public Mental Health Centers and Primary Care Centers, together with pharmacological treatment (i.e., antidepressants and / or anxiolytics).

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (TAU)

Intervention Type: BEHAVIORAL

TAU group that carries out Cognitive Behavioral Therapy in an individual format

Interventions

Unified Protocol

Intervention group that carries out the Unified Protocol in a group format

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (TAU)

TAU group that carries out Cognitive Behavioral Therapy in an individual format

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Anxiety or mood disorder is the main diagnosis
• 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)
• The patient is able to attend to the evaluation and treatment sessions
• The patient signs the informed consent form

Exclusion Criteria

• The patient presents a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder) or there is suicide risk at the time of assessment
• The patient has used substances in the last three months (excluding cannabis, coffee, and / or nicotine)
• The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable CBT principles

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Universitat Jaume I

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Osma, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Hospital General Universitario de Elda

Elda, , Spain

Site Status: RECRUITING

Clínica de Navarra

Pamplona, , Spain

Site Status: RECRUITING

Hospital Comarcal de Vinaròs

Vinaròs, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jorge Osma, Ph.D.

Role: CONTACT

osma@unizar.es

976861390

Facility Contacts

Alejandro Lizaur Utrilla

Role: primary

961622300

Olga Díaz Pardo

Role: primary

848422495

Benjamin Altozano, MD

Role: primary

964477000

References

Barlow DH, Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Allen LB, Ehrenreich-May J. Protocolo unificado para el tratamiento transdiagnóstico de los trastornos emocionales: Manual del terapeuta y manual del paciente.[The unified protocol for transdiagnostic treatment of emotional disorders: Client workbook and Therapist guide]. Madrid: Alianza Editorial; 2015.

Reference Type: BACKGROUND

Beck AT, Steer R. Beck Anxiety Inventory manual. San Antonio: Psychological Corporation;1993.

Reference Type: BACKGROUND

Gallagher MW, Sauer-Zavala SE, Boswell JF, Carl JR, Bullis J, Farchione TJ, Barlow DH. The Impact of the Unified Protocol for Emotional Disorders on Quality of Life. Int J Cogn Ther. 2013 Mar 1;6(1):10.1521/ijct.2013.6.1.57. doi: 10.1521/ijct.2013.6.1.57.

Reference Type: BACKGROUND

PMID: 24358405 (View on PubMed)

Osma J, Barrada JR, Garcia-Palacios A, Navarro-Haro M, Aguilar A. Internal Structure and Clinical Utility of the Anxiety Control Questionnaire-Revised (ACQ-R) Spanish Version. Span J Psychol. 2016 Oct 3;19:E63. doi: 10.1017/sjp.2016.69.

Reference Type: BACKGROUND

PMID: 27692017 (View on PubMed)

Osma J, Castellano C, Crespo E, García-PalaciosA. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in format group in a Spanish public mental health setting. PsicologíaConductual. 2015; 23 (3): 447-466.

Reference Type: BACKGROUND

Carl JR, Gallagher MW, Sauer-Zavala SE, Bentley KH, Barlow DH. A preliminary investigation of the effects of the unified protocol on temperament. Compr Psychiatry. 2014 Aug;55(6):1426-34. doi: 10.1016/j.comppsych.2014.04.015. Epub 2014 Apr 27.

Reference Type: BACKGROUND

PMID: 24933653 (View on PubMed)

Peris-Baquero O, Osma J. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Group Format in Spain: Results of a Noninferiority Randomized Controlled Trial at 15 Months after Treatment Onset. Depress Anxiety. 2023 Jun 30;2023:1981377. doi: 10.1155/2023/1981377. eCollection 2023.

Reference Type: DERIVED

PMID: 40224586 (View on PubMed)

Osma J, Peris-Baquero O, Suso-Ribera C, Farchione TJ, Barlow DH. Effectiveness of the Unified Protocol for transdiagnostic treatment of emotional disorders in group format in Spain: Results from a randomized controlled trial with 6-months follow-up. Psychother Res. 2022 Mar;32(3):329-342. doi: 10.1080/10503307.2021.1939190. Epub 2021 Jun 16.

Reference Type: DERIVED

PMID: 34132170 (View on PubMed)

Osma J, Suso-Ribera C, Garcia-Palacios A, Crespo-Delgado E, Robert-Flor C, Sanchez-Guerrero A, Ferreres-Galan V, Perez-Ayerra L, Malea-Fernandez A, Torres-Alfosea MA. 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. Health Qual Life Outcomes. 2018 Mar 12;16(1):46. doi: 10.1186/s12955-018-0866-2.

Reference Type: DERIVED

PMID: 29530035 (View on PubMed)

Other Identifiers

UJIUP

Identifier Type: -

Identifier Source: org_study_id