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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorder, Depressive Disorder, Emotional Problem, Emotional Disorder

Intervention / Treatment
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* Behavioral: UPA
* Behavioral: Active control condition (Progressive Relaxation Training)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: (UP-A)<br>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<br>* 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).<br>|
| Active Comparator: Active control condition<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 18 months after start of interventions | 
| 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. | Baseline to 18 months after start of interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 18 months after start of interventions | 
| 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. | Baseline to 18 months after start of interventions | 
| 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. | Baseline to 18 months after start of interventions | 
| Transdiagnostic dimensions | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescents, depression, anxiety, emotional problems, transdiagnostic, school, evidence-based