UP in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System

Implementation, Effficacy and Cost-effective Study of the Unified Protocol in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System

The present randomized, controlled trial will compare the efficacy, cost-effectiveness, and implementation characteristics of a blended intervention based on the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders against the treatment as usual in a sample of patients with emotional disorders in the Spanish National Health System.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Anxiety Disorders; Emotional Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (TAU); Behavioral: Blended intervention (UP-APP)

Detailed Description

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. Due to the excessive demand for treatment, mental health services of our National Health System (NHS) are collapsed with large waiting lists, which results in a great difficulty to dedicate the recommended time to attend patients who require psychological treatment. Therefore, it is needed to find solutions for the effective and cost-effective treatment of EDs in our NHS. In the last years, several solutions have been proposed to alleviate this important health problem.

The general objective of this project is to contribute to the dissemination of evidence-based psychological treatments in our Public National Health System for the most prevalent mental disorders in our society, emotional disorders (EDs). The investigators will study the efficacy, cost-effectiveness, and implementation characteristics (acceptability, usability, and utility) of a blended intervention which will enhance face-to-face treatment by incorporating an app-based intervention onsite treatment. Based on the most recent clinical advances in the treatment of EDs, the investigators will use the Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP). The investigators hypothesize that the blended intervention will be superior to the treatment as usual (face-to-face, specific-disorder treatment) because patients in the UP-APP condition will continue working with the app at home between sessions. In sum, this project is composed of three connected studies: a validation study in a clinical sample of patients with EDs, two pilot studies to help develop the app based on the UP principles, and a multicenter, randomized and controlled clinical trial that will be conducted by 12 clinical psychologist working in 8 different provinces in Spain.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Osma, Ph.D; Phone Number: 978645390; Email: osma@unizar.es

Study Locations

• Spain
  • Comunidad Valenciana
    • Vinaròs, Comunidad Valenciana, Spain, 12500
      • Recruiting
      • Hospital Comarcal de Vinaròs
      • Contact: Vanessa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Principal diagnosis of Emotional disorder (Evaluated by MINI interview)
• 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)
• To have a Smartphone
• Patients taking pharmacological treatment for their ED will be asked to maintain the same dosages and medications for at least 3 months prior to enrolling in the study and during the whole treatment
• The patient signs the informed consent form.

Exclusion Criteria:

• The patient presents a severe condition that would require to be prioritized for treatment, these include a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months
• The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable Cognitive behavioral therapy (CBT) principles within the past 5 years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UP in blended format; Clinicians will follow the UP therapist manual, 2nd edition, recently translated by Osma and Crespo (13,14). The same contents through a digital material (video and audio) will be integrated in the UP-APP. The program can be developed in a range of 12 to 16 sessions. The UP includes 8 modules	Behavioral: Blended intervention (UP-APP); Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)
Active Comparator: 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).	Behavioral: Cognitive Behavioral Therapy (TAU); TAU group that carries out Cognitive Behavioral Therapy in an individual format

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Depression Severity and Impairment Scale (ODSIS)	Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4.	Up to 12 months
Overall Anxiety Severity and Impairment Scale (OASIS)	The scale presents five items. These items are related with the frequency and intensity of anxiety symptoms and their interference with the person's work or school life and with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety).	Up to 12 months
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)	Diagnostic interview	Enrolment and Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Multidimensional Emotional Disorder Inventory (MEDI)	A self-report measure that includes only 49 items and enables to quickly assess the main transdiagnostic dimensions of Emotional disorders	Up to 12 months
Health-related quality of life (EuroQol-5D)	Evaluation through 5 items of quality of life.	Up to 12 months
Difficulties in Emotion Regulation Scale (DERS)	Consists of 36-item of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation	Up to 12 months
Evaluation questionnaire of the Unified Protocol (UP) modules	Consists of 7 items that evaluate the usefulness of the program to improve emotional regulation and the usefulness of each of the skills that are worked on in the different UP modules	Up to 12 months
Adaptation of Client Satisfaction Questionnaire [CSQ-8]	An adaptation of 13 items that measures quality of the intervention and its components, discomfort experienced during treatment and the experience of participating in a blended format.	Up to 12 months
Five Facet Mindfulness Questionnaire (FFMQ)	Is a 39-item questionnaire that measures five facets of mindfulness. responses use a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true)	Up to 12 months
Emotion Regulation Questionnaire (ERQ)	Consists of 10 items covering two factors: Cognitive Reappraisal (six items) and Expressive Suppression (four items). Items are rated on a 7-point Likert scale ranging from ''Strongly disagree'' to ''Strongly agree'	Up to 12 months
Credibility/Expectancy Questionnaire (CEQ)	The CEQ consists of six items scored on a scale of 1 to 9 and measures treatment expectancy and credibility of justification for use in clinical outcome studies.	Up to 12 months
System Usability Scale (SUS)	Composed of 10 statements that are scored on a 5-point scale of strength of agreement [0-100]	Up to 12 months
Client Service Receipt Inventory (CSRI)	Evaluate the emergency service (total visits), general medical inpatient hospital admissions (total days); outpatient health care services (total visits to general practitioner, nurse, social worker, psychologist, and other community health care professionals).	Up to 12 months
Working Alliance Inventory-Short (WAI-S)	Evaluate the therapeutic or working alliance	During psychological treatment
Quality-adjusted Life Years (QALYs)	Measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions.	Up to 12 months
UP-APP outcomes	Number and time of use of the UP-APP, videos viewed and exercises completed	During psychological treatment
Evaluation of the UP-APP	16 items that evaluate the opinion about the app's aesthetics, handling and components	Up to 12 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria Aragón
• Investigators: Principal Investigator: Jorge Osma, Ph.D, Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza

Publications and helpful links

General Publications

• Osma J, Martinez-Garcia L, Peris-Baquero O, Navarro-Haro MV, Gonzalez-Perez A, Suso-Ribera C. Implementation, efficacy and cost effectiveness of the unified protocol in a blended format for the transdiagnostic treatment of emotional disorders: a study protocol for a multicentre, randomised, superiority controlled trial in the Spanish National Health System. BMJ Open. 2021 Dec 31;11(12):e054286. doi: 10.1136/bmjopen-2021-054286.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Emotional Disorder; Unified Protocol; Public health; Transdiagnostic approach
• Additional Relevant MeSH Terms: Mental Disorders; Depressive Disorder; Anxiety Disorders; Mood Disorders
• Other Study ID Numbers: IPES/PI20/00697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Under request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No