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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.

NCT05581277

Emotional Disorder Post COVID-19 Condition Anxiety Disorders +1 more

UNKNOWN NA

Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain

NCT06547450

Emotional Disorder Anxiety Disorders Depressive Disorder

NOT_YET_RECRUITING NA

The Unified Protocol for the Treatment of Emotional Disorders in Spanish Public Mental Health System

NCT03064477

Emotional Disorder Anxiety Disorders Depressive Disorder

UNKNOWN NA

Group Version of the UP-A in a Spanish Public Mental Health Setting.

NCT06894368

Anxiety Disorders Depressive Disorder Emotional Disorder

COMPLETED NA

Cost-benefit Evaluation of a Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care

NCT04847310

Emotional Disorder Depression Somatoform Disorders +1 more

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotional Disorder Anxiety Disorders Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Blended intervention (UP-APP)

Intervention Type BEHAVIORAL

Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)

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).

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (TAU)

Intervention Type BEHAVIORAL

TAU group that carries out Cognitive Behavioral Therapy in an individual format

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blended intervention (UP-APP)

Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy (TAU)

TAU group that carries out Cognitive Behavioral Therapy in an individual format

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No