Clinical trial NCT03064477: The Unified Protocol for the Treatment of Emotional Disorders in Spanish Public Mental Health System
Official title: Cost-efficacy and Acceptability of the Unified Protocol for the Treatment of Emotional Disorders in the Spanish Public Mental Health System Using a Group Format
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Disorder
Anxiety Disorders
Depressive Disorder
Keywords: Unified Protocol
Transdiagnostic approach
Public health
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Universidad de Zaragoza
First posted: 2017-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All consecutive patients with emotional disorders attending any of the collaborating centers will be asked to participate in the present study. Once inclusion criteria are met, each patient will be randomly assigned to one of the two experimental groups: TAU or UP. Randomization will be performed by a researcher unrelated to the study using a computer-generated sequence (Randomizer). Randomization will be stratified according to the severity of the primary measures of depression and anxiety, using the recommended cutoff in the manuals. Stratification will be made to ensure a comparable proportion of severely depressed and anxious individuals in each group. For each subgroup (i.e., severe or less severe depression and/or anxiety), participants will be randomly assigned to the UP or to TAU.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the severity of depressive symptoms
timeFrame: Up to 12 months
measure: Change in the severity of anxiety symptoms
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: Up to 12 months
measure: Change in the general tendency to worry
timeFrame: Up to 12 months
measure: Change in obsessions and compulsions
timeFrame: Up to 12 months
measure: Change in the severity of panic symptoms
timeFrame: Up to 12 months
measure: Change in agoraphobia severity
timeFrame: Up to 12 months
measure: Change in the severity of post-traumatic symptoms
timeFrame: Up to 12 months
measure: Change in social anxiety symptoms
timeFrame: Up to 12 months
measure: Change in the severity of hypochondriacal attitudes
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Elda
country: Spain
facility: Hospital General Universitario de Elda
city: Pamplona
country: Spain
facility: Clínica de Navarra
city: Vinaroz
country: Spain
facility: Hospital Comarcal de Vinaròs
Study officials:
affiliation: Assistant Professor
name: Jorge Osma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Beck AT, Steer R. Beck Anxiety Inventory manual. San Antonio: Psychological Corporation;1993.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.