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

NCT05322642 | Unknown DMC

• 1 other identifier: Universidad de La Rioja
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorder; Depressive Disorder; Emotional Problem; Emotional Disorder

Keywords

adolescents; depression; anxiety; emotional problems; transdiagnostic; school; evidence-based

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Emotional and behavioural problems

  Baseline to 18 months after start of interventions

• Health-related quality of life

  Baseline to 18 months after start of interventions

• Positive and Negative Affect

  Baseline to 18 months after start of interventions

• Transdiagnostic dimensions

  Baseline to 18 months after start of interventions

• Educational achievement outcome

  Baseline to 18 months after start of interventions

Study Arms (2)

Experimental: (UP-A)

EXPERIMENTAL

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

Active control condition

ACTIVE COMPARATOR

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)

Interventions

UPA 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).

Experimental: (UP-A)

Active control condition (Progressive Relaxation Training) 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.

Active control condition

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Universidad de la Rioja

Logroño, La Rioja, 26002, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 31078836 BACKGROUND

• 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.

  PMID: 32056776 BACKGROUND

• 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.

  PMID: 33182711 BACKGROUND

• 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.

  PMID: 32394551 BACKGROUND

• 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.

  PMID: 28768327 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Eduardo Fonseca Pedrero, PhD

  University of La Rioja

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Fonseca-Pedrero, PHD

CONTACT

941293222; eduardo.fonseca@unirioja.es

Eduardo Fonseca Pedrero, phd

CONTACT

941293222; eduardo.fonseca@unirioja.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 12, 2022
• Study Start: December 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: January 30, 2024
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

ES (1)