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)

Eduardo Fonseca Pedrero

Status: Enrolling

Conditions: Emotional Disorder; Emotional Problem; Anxiety Disorder; Depressive Disorder

Treatments: Behavioral: UPA; Behavioral: Active control condition (Progressive Relaxation Training)

Study type: Interventional

Funder types: Other

Identifiers

NCT05322642

Universidad de La Rioja

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Experimental: (UP-A)

Experimental group

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.

Treatment:

Behavioral: UPA

Active control condition

Active Comparator group

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.

Treatment:

Behavioral: Active control condition (Progressive Relaxation Training)