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

Not Applicable

• Conditions: Depressive Disorder; Emotional Problem; Anxiety Disorder; Emotional Disorder
• Interventions: Behavioral: Active control condition (Progressive Relaxation Training); Behavioral: UPA

• Registration Number: NCT05322642
• Lead Sponsor: Eduardo Fonseca Pedrero

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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-03-15
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-12
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13
• Primary Completion: 2022-07-01
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active control condition	Active control condition (Progressive Relaxation Training)	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.
Experimental: (UP-A)	UPA	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Universidad de la Rioja; 🇪🇸 Logroño, La Rioja, Spain