Clinical trial NCT04304911: UP in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Disorder
Anxiety Disorders
Depressive Disorder
Keywords: Emotional Disorder
Unified Protocol
Public health
Transdiagnostic approach
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Up to 12 months
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Up to 12 months
measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
timeFrame: Enrolment and Up to 12 months
Secondary outcomes:
measure: The Multidimensional Emotional Disorder Inventory (MEDI)
timeFrame: Up to 12 months
measure: Health-related quality of life (EuroQol-5D)
timeFrame: Up to 12 months
measure: Adaptation of Client Satisfaction Questionnaire [CSQ-8]
timeFrame: Up to 12 months
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Up to 12 months
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Up to 12 months
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to 12 months
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Up to 12 months
measure: System Usability Scale (SUS)
timeFrame: Up to 12 months
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Up to 12 months
measure: Working Alliance Inventory-Short (WAI-S)
timeFrame: During psychological treatment
measure: Quality-adjusted Life Years (QALYs)
timeFrame: Up to 12 months
measure: UP-APP outcomes
timeFrame: During psychological treatment
measure: Evaluation of the UP-APP
timeFrame: Up to 12 months
measure: Evaluation questionnaire of the Unified Protocol (UP) modules
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Vinaròs
country: Spain
facility: Hospital Comarcal de Vinaròs
state: Comunidad Valenciana
Study officials:
affiliation: Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza
name: Jorge Osma, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.