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

Primary Purpose

Emotional Disorder, Anxiety Disorders, Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Blended intervention (UP-APP)
Cognitive Behavioral Therapy (TAU)
Sponsored by
Instituto de Investigación Sanitaria Aragón
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotional Disorder focused on measuring Emotional Disorder, Unified Protocol, Public health, Transdiagnostic approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Comarcal de VinaròsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UP in blended format

Treatment as usual (TAU)

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.
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).
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Diagnostic interview

Secondary Outcome Measures

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
Health-related quality of life (EuroQol-5D)
Evaluation through 5 items of quality of life.
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.
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)
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'
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
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.
System Usability Scale (SUS)
Composed of 10 statements that are scored on a 5-point scale of strength of agreement [0-100]
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).
Working Alliance Inventory-Short (WAI-S)
Evaluate the therapeutic or working alliance
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.
UP-APP outcomes
Number and time of use of the UP-APP, videos viewed and exercises completed
Evaluation of the UP-APP
16 items that evaluate the opinion about the app's aesthetics, handling and components
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

Full Information

First Posted
March 9, 2020
Last Updated
September 22, 2023
Sponsor
Instituto de Investigación Sanitaria Aragón
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1. Study Identification

Unique Protocol Identification Number
NCT04304911
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria Aragón

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disorder, Anxiety Disorders, Depressive Disorder
Keywords
Emotional Disorder, Unified Protocol, Public health, Transdiagnostic approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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).
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UP in blended format
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as usual (TAU)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Blended intervention (UP-APP)
Intervention Description
Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (TAU)
Intervention Description
TAU group that carries out Cognitive Behavioral Therapy in an individual format
Primary Outcome Measure Information:
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Description
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
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
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
Title
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Description
Diagnostic interview
Time Frame
Enrolment and Up to 12 months
Secondary Outcome Measure Information:
Title
The Multidimensional Emotional Disorder Inventory (MEDI)
Description
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
Title
Health-related quality of life (EuroQol-5D)
Description
Evaluation through 5 items of quality of life.
Time Frame
Up to 12 months
Title
Adaptation of Client Satisfaction Questionnaire [CSQ-8]
Description
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
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
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
Title
Emotion Regulation Questionnaire (ERQ)
Description
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
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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
Title
Credibility/Expectancy Questionnaire (CEQ)
Description
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
Title
System Usability Scale (SUS)
Description
Composed of 10 statements that are scored on a 5-point scale of strength of agreement [0-100]
Time Frame
Up to 12 months
Title
Client Service Receipt Inventory (CSRI)
Description
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
Title
Working Alliance Inventory-Short (WAI-S)
Description
Evaluate the therapeutic or working alliance
Time Frame
During psychological treatment
Title
Quality-adjusted Life Years (QALYs)
Description
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
Title
UP-APP outcomes
Description
Number and time of use of the UP-APP, videos viewed and exercises completed
Time Frame
During psychological treatment
Title
Evaluation of the UP-APP
Description
16 items that evaluate the opinion about the app's aesthetics, handling and components
Time Frame
Up to 12 months
Title
Evaluation questionnaire of the Unified Protocol (UP) modules
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Osma, Ph.D
Phone
978645390
Email
osma@unizar.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Osma, Ph.D
Organizational Affiliation
Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Comarcal de Vinaròs
City
Vinaròs
State/Province
Comunidad Valenciana
ZIP/Postal Code
12500
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Under request
Citations:
PubMed Identifier
34972770
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.
Results Reference
derived
Links:
URL
https://www.iisaragon.es/grupos-de-investigacion/neurociencia-salud-mental-y-organos-de-los-sentidos/giis082-investigacion-en-personalidad-emocion-y-salud-ipes/
Description
Related Info
URL
https://www.alianzaeditorial.es/libro/manuales/aplicaciones-del-protocolo-unificado-para-el-tratamiento-transdiagnostico-de-la-disregulacion-emocional-jorge-osma-9788491817260/
Description
Related Info
URL
https://www.alianzaeditorial.es/libro/manuales/protocolo-unificado-para-el-tratamiento-transdiagnostico-de-los-trastornos-emocionales-manual-del-terapeuta-david-h-barlow-9788491814795/
Description
Related Info
URL
https://www.alianzaeditorial.es/libro/manuales/protocolo-unificado-para-el-tratamiento-transdiagnostico-de-los-trastornos-emocionales-manual-del-paciente-david-h-barlow-9788491814818/
Description
Related Info
URL
https://www.alianzaeditorial.es/libro/manuales/protocolo-unificado-para-el-tratamiento-transdiagnostico-de-los-trastornos-emocionales-david-h-barlow-9788491041368/
Description
Related Info

Learn more about this trial

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

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