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

Depressive Disorder Clinical Trial

— PSICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322642
• Other study ID #: Universidad de La Rioja
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: April 2022
• Source: University of La Rioja
• Contact: Eduardo Fonseca-Pedrero, PHD
• Phone: 941293222
• Email: eduardo.fonseca[@]unirioja.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 30, 2024
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depressive Disorder
• Disease
• Emotional Disorder
• Emotional Problem

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
Spain	Universidad de la Rioja	Logroño	La Rioja

Sponsors (3)

Lead Sponsor	Collaborator
Eduardo Fonseca Pedrero	Consejo General de la Psicología de España, Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Sandín B, García-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). pii: E8306. doi: 10.3390/ijerph17228306. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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