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

NCT03064477 | Unknown DMC

• 1 other identifier: UJIUP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Emotional Disorder; Anxiety Disorders; Depressive Disorder

Keywords

Unified Protocol; Transdiagnostic approach; Public health

Outcome Measures

Primary Outcomes (2)

• Change in the severity of depressive symptoms

  The Beck Depression Inventory-II (BDI-II) is a largely used measure that evaluates depressive symptomatology. It consists of 21 items, each including a set of four different sentences that reflect an increasing degree of depression. Responses are obtained through a 4-point Likert scale ranging from 0 (lowest degree of depressive symptomatology) to 3 (most severe symptomatology). Scores in the BDI-II range from 0 to 63. The alpha coefficient obtained in the Spanish version (.87) indicates a good internal consistency.

  Up to 12 months

• Change in the severity of anxiety symptoms

  The Beck Anxiety Inventory (BAI) is a frequently used measure of the severity of anxiety symptoms. The BAI includes 21 items. Each item reflects an anxiety symptom and respondents are asked to rate the extent to which the symptoms affected them during the past week. Responses are obtained through a 4-point Likert scale ranging from 0 = not at all to 3 = severely. Total score ranges from 0 to 63. The internal consistency estimate for the Spanish version of the BAI is high (.93).

  Up to 12 months

Secondary Outcomes (8)

• Change in quality of life

  Up to 12 months

• Change in the general tendency to worry

  Up to 12 months

• Change in obsessions and compulsions

  Up to 12 months

• Change in the severity of panic symptoms

  Up to 12 months

• Change in agoraphobia severity

  Up to 12 months

Study Arms (2)

Unified Protocol (UP)

EXPERIMENTAL

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.

Behavioral: Unified Protocol

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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).

Behavioral: Cognitive Behavioral Therapy (TAU)

Interventions

Unified Protocol BEHAVIORAL

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

Unified Protocol (UP)

Cognitive Behavioral Therapy (TAU) BEHAVIORAL

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

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Jaume I: lead
• Universidad de Zaragoza: collaborator

Study Sites (3)

Hospital General Universitario de Elda

Elda, Spain

RECRUITING

Clínica de Navarra

Pamplona, Spain

RECRUITING

Hospital Comarcal de Vinaròs

Vinaròs, Spain

RECRUITING

Related Publications (9)

• 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.

  BACKGROUND

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

  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.

  PMID: 24358405 BACKGROUND

• 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.

  PMID: 27692017 BACKGROUND

• 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.

  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.

  PMID: 24933653 BACKGROUND

• 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.

  PMID: 40224586 DERIVED

• 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.

  PMID: 34132170 DERIVED

• 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.

  PMID: 29530035 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jorge Osma, Ph.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Osma, Ph.D.

CONTACT

976861390; osma@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients (participants) will know the treatment they have been assigned to, but they will not know whether that treatment is considered TAU or experimental (UP). Healthcare professionals and researchers will know the condition each patient has been assigned to (mandatory to provide a given type of intervention).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: September 14, 2014
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)