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

NCT04304911 | Unknown DMC

• 1 other identifier: IPES/PI20/00697
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Disorder; Anxiety Disorders; Depressive Disorder

Keywords

Emotional Disorder; Unified Protocol; Public health; Transdiagnostic approach

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)

  Diagnostic interview

  Enrolment and Up to 12 months

Secondary Outcomes (14)

• The Multidimensional Emotional Disorder Inventory (MEDI)

  Up to 12 months

• Health-related quality of life (EuroQol-5D)

  Up to 12 months

• Adaptation of Client Satisfaction Questionnaire [CSQ-8]

  Up to 12 months

• Five Facet Mindfulness Questionnaire (FFMQ)

  Up to 12 months

• Emotion Regulation Questionnaire (ERQ)

  Up to 12 months

Study Arms (2)

UP in blended format

EXPERIMENTAL

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)

Treatment as usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

Blended intervention (UP-APP) BEHAVIORAL

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

UP in blended format

Cognitive Behavioral Therapy (TAU) BEHAVIORAL

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

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Hospital Comarcal de Vinaròs

Vinaròs, Valencia, 12500, Spain

RECRUITING

Related Publications (2)

• Martinez-Garcia L, Schaeuffele C, Peris-Baquero O, Torres Alfosea MA, Osma J. Acceptability and preliminary effectiveness of the Unified Protocol in blended format in the Spanish public mental health system: Results from a Pilot Randomized Controlled Trial. Psychother Res. 2025 Aug 12:1-18. doi: 10.1080/10503307.2025.2541707. Online ahead of print.

  PMID: 40792553 DERIVED

• 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.

  PMID: 34972770 DERIVED

Related Links

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MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jorge Osma, Ph.D

  Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Osma, Ph.D

CONTACT

978645390; osma@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)