PSICE: 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

Sponsor

Eduardo Fonseca Pedrero (Other)

Overall Status

Recruiting

CT.gov ID

NCT05322642

Collaborator

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

300

Enrollment

Location

Arms

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder Depressive Disorder Emotional Problem Emotional Disorder	Behavioral: UPA Behavioral: Active control condition (Progressive Relaxation Training)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jan 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Depression symptoms [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.
Anxiety symptoms [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.

Secondary Outcome Measures

Emotional and behavioural problems [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.
Health-related quality of life [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.
Positive and Negative Affect [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.
Transdiagnostic dimensions [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.
Educational achievement outcome [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de la Rioja	Logroño	La Rioja	Spain	26002

Sponsors and Collaborators

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