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Efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents With Moderate Emotional Symptoms in Educational Settings (PSICE)

Primary Purpose

Anxiety Disorder, Depressive Disorder, Emotional Problem

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
UPA
Active control condition (Progressive Relaxation Training)
Sponsored by
Eduardo Fonseca Pedrero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorder focused on measuring adolescents, depression, anxiety, emotional problems, transdiagnostic, school, evidence-based

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be 12-18 years old
  • Written informed consent from adolescent and legal guardian
  • Being able to understand and read Spanish.
  • Moderate depressive and anxiety symptoms according to the screening (score moderate level in the PHQ-9 and GAD-7).

Exclusion Criteria:

  • Being diagnosed a mental disorder or alcohol and/or substance dependence disorder.
  • The presence of high suicidal risk
  • A medical disease or condition which prevent the participant from carry out the psychological treatment.
  • Receiving another psychological treatment while the study is still ongoing.
  • The increase and/or changes in the medication of participants receiving pharmacological treatment during the study

Sites / Locations

  • Universidad de la RiojaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: (UP-A)

Active control condition

Arm Description

The UP-A (Ehrenreich et al., 2008) is an emotion-focused, transdiagnostic CBT for adolescents A 10-session youth-focused programmed by adapting the core modules of UP-A, for indicated prevention and school settings.

The active control condition will be based on the 10 session of Progressive Relaxation Training programme of Bernstein and Borkovec. It follows a similar structure as the UP-A. A group format will be used.

Outcomes

Primary Outcome Measures

Depression symptoms
Change in the Patient Health Questionnaire-9 (PHQ-9) total score. PHQ-9 total score for the nine items ranges from 0 to 27.Higher scores mean a worse outcome.
Anxiety symptoms
Change in the Generalised Anxiety Disorder Assessment (GAD-7) total score. GAD-7 total score for the seven items ranges from 0 to 21.Higher scores mean a worse outcome.

Secondary Outcome Measures

Emotional and behavioural problems
Change in the Strengths and Difficulties Questionnaire (SDQ) total score. Total dificulties score range from 0 to 40. Higher scores mean a worse outcome.
Health-related quality of life
Change in the Kidscreeen-10 (Health-related quality of life) total score. Total score range from 10 to 50. Higher scores mean a better outcome.
Positive and Negative Affect
Change in the Positive and Negative Affect Schedule-Brief child (PANAS-Child brief version) scores. Total scores range (both positive and negative Affect) from 5 to 25. For Positive Affect dimension Higher scores mean a better outcome. For Negative Affect dimension higher scores mean a worse outcome.
Transdiagnostic dimensions
Change in Multidimensional Emotional Disorders Inventory (MEDI) scores. Total score range from 0 to 392 Higher scores mean a worse outcome.
Educational achievement outcome
Educational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome.

Full Information

First Posted
March 15, 2022
Last Updated
April 12, 2022
Sponsor
Eduardo Fonseca Pedrero
Collaborators
Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo, Consejo General de la Psicología de España
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1. Study Identification

Unique Protocol Identification Number
NCT05322642
Brief Title
Efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents With Moderate Emotional Symptoms in Educational Settings
Acronym
PSICE
Official Title
Efficacy of the Unified Protocol for Transdiagnostic Treatment for Adolescents With Symptoms of Anxiety and Depression: a School-based Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eduardo Fonseca Pedrero
Collaborators
Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo, Consejo General de la Psicología de España

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 main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment.
Detailed Description
Emotional problems, such as anxiety and depression, are among the leading causes of associated disability and burden of disease worldwide among young people. Therefore, it is necessary to address this emerging social challenge through the implementation of prevention strategies in relevant stages of development such as adolescence. In recent years, a transdiagnosis approach to emotional disorders has been promoted, highlighting the unified protocol for transdiagnostic treatment of emotional disorders and symptoms in its different versions (adulthood, adolescence, and childhood). In this context, the main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment. Adolescents aged 12-18 at high risk of for anxiety and depression disorders (cut-off scores 10-15 points, PHQ-9 and GAD-7) are selected. The design is a randomized controlled trial with two groups: active control (relaxation) and experimental (UP-A). Pre-test, post-test, and follow-up at 6, 12 and 18 months will be carried out. The impact of different behavioural, cognitive, affective, social, and academic functioning indicators is analyzed, as well as their effects in the short, medium, and long term. The satisfaction of the program by users (students, parents, and professionals) will also be evaluated. The implementation and validation of manualized and empirically validated psychological intervention programs, such as UP-A, should be a priority in educational and socio-health policies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Depressive Disorder, Emotional Problem, Emotional Disorder
Keywords
adolescents, depression, anxiety, emotional problems, transdiagnostic, school, evidence-based

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: (UP-A)
Arm Type
Experimental
Arm Description
The UP-A (Ehrenreich et al., 2008) is an emotion-focused, transdiagnostic CBT for adolescents A 10-session youth-focused programmed by adapting the core modules of UP-A, for indicated prevention and school settings.
Arm Title
Active control condition
Arm Type
Active Comparator
Arm Description
The active control condition will be based on the 10 session of Progressive Relaxation Training programme of Bernstein and Borkovec. It follows a similar structure as the UP-A. A group format will be used.
Intervention Type
Behavioral
Intervention Name(s)
UPA
Intervention Description
UP-A is divided into five main treatment modules and three optional modules. The UP-A seek to positively affect how adolescents with anxiety and/ or depression experiences, think about, and respond to a broad range of negative and positive emotions, rather than disorder-specific emotions (e.g., fear, sadness).
Intervention Type
Behavioral
Intervention Name(s)
Active control condition (Progressive Relaxation Training)
Intervention Description
Progressive Relaxation Training (Bernstein and Borkovec) program is divided in ten sessions. Relaxation training often is used in behavior therapy as a means to reduce anxiety, tension, and stress. The goal is to release tension from your muscles, while helping you recognize what that tension feels like.
Primary Outcome Measure Information:
Title
Depression symptoms
Description
Change in the Patient Health Questionnaire-9 (PHQ-9) total score. PHQ-9 total score for the nine items ranges from 0 to 27.Higher scores mean a worse outcome.
Time Frame
Baseline to 18 months after start of interventions
Title
Anxiety symptoms
Description
Change in the Generalised Anxiety Disorder Assessment (GAD-7) total score. GAD-7 total score for the seven items ranges from 0 to 21.Higher scores mean a worse outcome.
Time Frame
Baseline to 18 months after start of interventions
Secondary Outcome Measure Information:
Title
Emotional and behavioural problems
Description
Change in the Strengths and Difficulties Questionnaire (SDQ) total score. Total dificulties score range from 0 to 40. Higher scores mean a worse outcome.
Time Frame
Baseline to 18 months after start of interventions
Title
Health-related quality of life
Description
Change in the Kidscreeen-10 (Health-related quality of life) total score. Total score range from 10 to 50. Higher scores mean a better outcome.
Time Frame
Baseline to 18 months after start of interventions
Title
Positive and Negative Affect
Description
Change in the Positive and Negative Affect Schedule-Brief child (PANAS-Child brief version) scores. Total scores range (both positive and negative Affect) from 5 to 25. For Positive Affect dimension Higher scores mean a better outcome. For Negative Affect dimension higher scores mean a worse outcome.
Time Frame
Baseline to 18 months after start of interventions
Title
Transdiagnostic dimensions
Description
Change in Multidimensional Emotional Disorders Inventory (MEDI) scores. Total score range from 0 to 392 Higher scores mean a worse outcome.
Time Frame
Baseline to 18 months after start of interventions
Title
Educational achievement outcome
Description
Educational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome.
Time Frame
Baseline to 18 months after start of interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be 12-18 years old Written informed consent from adolescent and legal guardian Being able to understand and read Spanish. Moderate depressive and anxiety symptoms according to the screening (score moderate level in the PHQ-9 and GAD-7). Exclusion Criteria: Being diagnosed a mental disorder or alcohol and/or substance dependence disorder. The presence of high suicidal risk A medical disease or condition which prevent the participant from carry out the psychological treatment. Receiving another psychological treatment while the study is still ongoing. The increase and/or changes in the medication of participants receiving pharmacological treatment during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Fonseca-Pedrero, PHD
Phone
941293222
Ext
9332
Email
eduardo.fonseca@unirioja.es
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Fonseca Pedrero, phd
Phone
941293222
Ext
9332
Email
eduardo.fonseca@unirioja.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Fonseca Pedrero, PhD
Organizational Affiliation
University of La Rioja
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de la Rioja
City
Logroño
State/Province
La Rioja
ZIP/Postal Code
26002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Fonseca-Pedrero, phD
Phone
349441299332
Email
eduardo.fonseca@unirioja.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31078836
Citation
Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.
Results Reference
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PubMed Identifier
32056776
Citation
de la Torre-Luque A, Fiol-Veny A, Essau CA, Balle M, Bornas X. Effects of a transdiagnostic cognitive behaviour therapy-based programme on the natural course of anxiety symptoms in adolescence. J Affect Disord. 2020 Mar 1;264:474-482. doi: 10.1016/j.jad.2019.11.078. Epub 2019 Nov 14.
Results Reference
background
PubMed Identifier
33182711
Citation
Sandin B, Garcia-Escalera J, Valiente RM, Espinosa V, Chorot P. Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial. Int J Environ Res Public Health. 2020 Nov 10;17(22):8306. doi: 10.3390/ijerph17228306.
Results Reference
background
PubMed Identifier
32394551
Citation
Barlow DH, Harris BA, Eustis EH, Farchione TJ. The unified protocol for transdiagnostic treatment of emotional disorders. World Psychiatry. 2020 Jun;19(2):245-246. doi: 10.1002/wps.20748. No abstract available.
Results Reference
background
PubMed Identifier
28768327
Citation
Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
Results Reference
background
Citation
Ehrenreich-May J., Kennedy S.M., Sherman J.A., Bilek E.L., Buzzella B.A., Bennett S.M., Barlow D.H. Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and AdolescentsTherapist Guide: Therapist Guide. Oxford University Press; New York, NY, USA: 2017.
Results Reference
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Learn more about this trial

Efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents With Moderate Emotional Symptoms in Educational Settings

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