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

NCT ID: NCT05322642

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-01-30

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.

Conditions

Anxiety Disorder; Depressive Disorder; Emotional Problem; Emotional Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

UPA

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Active control condition (Progressive Relaxation Training)

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo

OTHER

Sponsor Role: collaborator

Consejo General de la Psicología de España

UNKNOWN

Sponsor Role: collaborator

Eduardo Fonseca Pedrero

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Fonseca Pedrero

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eduardo Fonseca Pedrero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of La Rioja

Locations

Universidad de la Rioja

Logroño, La Rioja, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Eduardo Fonseca-Pedrero, PHD

Role: CONTACT

eduardo.fonseca@unirioja.es

941293222 ext. 9332

Eduardo Fonseca Pedrero, phd

Role: CONTACT

eduardo.fonseca@unirioja.es

941293222 ext. 9332

Facility Contacts

Eduardo Fonseca-Pedrero, phD

Role: primary

eduardo.fonseca@unirioja.es

349441299332

References

Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.

Reference Type: BACKGROUND

PMID: 31078836 (View on PubMed)

de la Torre-Luque A, Fiol-Veny A, Essau CA, Balle M, Bornas X. Effects of a transdiagnostic cognitive behaviour therapy-based programme on the natural course of anxiety symptoms in adolescence. J Affect Disord. 2020 Mar 1;264:474-482. doi: 10.1016/j.jad.2019.11.078. Epub 2019 Nov 14.

Reference Type: BACKGROUND

PMID: 32056776 (View on PubMed)

Sandin B, Garcia-Escalera J, Valiente RM, Espinosa V, Chorot P. Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial. Int J Environ Res Public Health. 2020 Nov 10;17(22):8306. doi: 10.3390/ijerph17228306.

Reference Type: BACKGROUND

PMID: 33182711 (View on PubMed)

Barlow DH, Harris BA, Eustis EH, Farchione TJ. The unified protocol for transdiagnostic treatment of emotional disorders. World Psychiatry. 2020 Jun;19(2):245-246. doi: 10.1002/wps.20748. No abstract available.

Reference Type: BACKGROUND

PMID: 32394551 (View on PubMed)

Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.

Reference Type: BACKGROUND

PMID: 28768327 (View on PubMed)

Ehrenreich-May J., Kennedy S.M., Sherman J.A., Bilek E.L., Buzzella B.A., Bennett S.M., Barlow D.H. Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and AdolescentsTherapist Guide: Therapist Guide. Oxford University Press; New York, NY, USA: 2017.

Reference Type: BACKGROUND

Other Identifiers

Universidad de La Rioja

Identifier Type: -

Identifier Source: org_study_id