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.
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
Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)
TAU group that carries out Cognitive Behavioral Therapy in an individual format
Hospital Comarcal de Vinaròs
Vinaròs, Valencia, Spain
RECRUITINGOverall 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.
Time frame: 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).
Time frame: Up to 12 months
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Diagnostic interview
Time frame: Enrolment and Up to 12 months
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
Time frame: Up to 12 months
Health-related quality of life (EuroQol-5D)
Evaluation through 5 items of quality of life.
Time frame: 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.
Time frame: Up to 12 months
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INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
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)
Time frame: 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'
Time frame: 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
Time frame: 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.
Time frame: Up to 12 months
System Usability Scale (SUS)
Composed of 10 statements that are scored on a 5-point scale of strength of agreement \[0-100\]
Time frame: 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).
Time frame: Up to 12 months
Working Alliance Inventory-Short (WAI-S)
Evaluate the therapeutic or working alliance
Time frame: 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.
Time frame: Up to 12 months
UP-APP outcomes
Number and time of use of the UP-APP, videos viewed and exercises completed
Time frame: During psychological treatment
Evaluation of the UP-APP
16 items that evaluate the opinion about the app's aesthetics, handling and components
Time frame: 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
Time frame: Up to 12 months