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)

April 12, 2022 updated by: Eduardo Fonseca Pedrero

Efficacy of the Unified Protocol for Transdiagnostic Treatment for Adolescents With Symptoms of Anxiety and Depression: a School-based Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • La Rioja
      • Logroño, La Rioja, Spain, 26002
        • Recruiting
        • Universidad de la Rioja
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: (UP-A)
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.
Behavioral: UPA
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).
Active Comparator: Active control condition

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.
Behavioral: Active control condition (Progressive Relaxation Training)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression symptoms
Time Frame: Baseline to 18 months after start of interventions
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.
Baseline to 18 months after start of interventions
Anxiety symptoms
Time Frame: Baseline to 18 months after start of interventions
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.
Baseline to 18 months after start of interventions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional and behavioural problems
Time Frame: Baseline to 18 months after start of interventions
Change in the Strengths and Difficulties Questionnaire (SDQ) total score. Total dificulties score range from 0 to 40. Higher scores mean a worse outcome.
Baseline to 18 months after start of interventions
Health-related quality of life
Time Frame: Baseline to 18 months after start of interventions
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.
Baseline to 18 months after start of interventions
Positive and Negative Affect
Time Frame: Baseline to 18 months after start of interventions
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.
Baseline to 18 months after start of interventions
Transdiagnostic dimensions
Time Frame: Baseline to 18 months after start of interventions
Change in Multidimensional Emotional Disorders Inventory (MEDI) scores. Total score range from 0 to 392 Higher scores mean a worse outcome.
Baseline to 18 months after start of interventions
Educational achievement outcome
Time Frame: Baseline to 18 months after start of interventions
Educational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome.
Baseline to 18 months after start of interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eduardo Fonseca Pedrero

Collaborators

Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo
Consejo General de la Psicología de España

Investigators

  • Principal Investigator: Eduardo Fonseca Pedrero, PhD, University of La Rioja

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Universidad de La Rioja

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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