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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04304911
• Other study ID #: IPES/PI20/00697
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: Jorge Osma, Ph.D
• Phone: 978645390
• Email: osma[@]unizar.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder
• Emotional Disorder
• Mood Disorders

Intervention

Behavioral:
• Blended intervention (UP-APP)
Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)
• Cognitive Behavioral Therapy (TAU)
TAU group that carries out Cognitive Behavioral Therapy in an individual format

Locations

Country	Name	City	State
Spain	Hospital Comarcal de Vinaròs	Vinaròs	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria Aragón

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)	Diagnostic interview	Enrolment and Up to 12 months
Secondary	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
Secondary	Health-related quality of life (EuroQol-5D)	Evaluation through 5 items of quality of life.	Up to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Working Alliance Inventory-Short (WAI-S)	Evaluate the therapeutic or working alliance	During psychological treatment
Secondary	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
Secondary	UP-APP outcomes	Number and time of use of the UP-APP, videos viewed and exercises completed	During psychological treatment
Secondary	Evaluation of the UP-APP	16 items that evaluate the opinion about the app's aesthetics, handling and components	Up to 12 months
Secondary	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

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