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

Sponsor

Instituto de Investigación Sanitaria Aragón (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04304911

Collaborator

(none)

310

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Emotional Disorder Anxiety Disorders Depressive Disorder	Behavioral: Blended intervention (UP-APP) Behavioral: Cognitive Behavioral Therapy (TAU)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

310 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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: Treatment as Usual (TAU) or UP-APP. 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-APP or to TAU.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: Treatment as Usual (TAU) or UP-APP. 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-APP or to TAU.

Masking:

Single (Participant)

Masking Description:

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-APP). Healthcare professionals and researchers will know the condition each patient has been assigned to (mandatory to provide a given type of intervention).

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Overall Depression Severity and Impairment Scale (ODSIS) [Up to 12 months]
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.
Overall Anxiety Severity and Impairment Scale (OASIS) [Up to 12 months]
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).
Mini International Neuropsychiatric Interview (MINI) [Enrolment and Up to 12 months]
Diagnostic interview

Secondary Outcome Measures

The Multidimensional Emotional Disorder Inventory (MEDI) [Up to 12 months]
A self-report measure that includes only 49 items and enables to quickly assess the main transdiagnostic dimensions of Emotional disorders
Health-related quality of life (EuroQol-5D) [Up to 12 months]
Evaluation through 5 items of quality of life.
Treatment Opinion Scale (TOS) [Up to 12 months]
Ad hoc
Five Facet Mindfulness Questionnaire (FFMQ) [Up to 12 months]
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)
Emotion Regulation Questionnaire (ERQ) [Up to 12 months]
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'
Brief Experiential Avoidance Questionnaire (BEAQ) [Up to 12 months]
A self-report questionnaire with 15 items that measure experiential avoidance. The items are rated on a 6-point Likert scale (1="strongly disagree" to 6="strongly agree"). The scores range from 15 to 90 points, with higher scores showing greater experiential avoidance
Difficulties in Emotion Regulation Scale (DERS) [Up to 12 months]
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
Credibility/Expectancy Questionnaire (CEQ) [Up to 12 months]
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.
System Usability Scale (SUS) [Up to 12 months]
Composed of 10 statements that are scored on a 5-point scale of strength of agreement [0-100]
Client Service Receipt Inventory (CSRI) [Up to 12 months]
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).
Working Alliance Inventory-Short (WAI-S) [During psychological treatment]
Evaluate the therapeutic or working alliance
Quality-adjusted Life Years (QALYs) [Up to 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.