NCT04182061

Internet Transdiagnostic-CBT for Anxiety and Depression in Adolescents

Completed NA Last updated 9 January 2024

What this trial tests

NA trial testing The AMTE protocol in Anxiety Disorder in 60 participants. Completed in 30 September 2023.

Timeline

15 November 2019

Primary endpoint
30 June 2023

30 September 2023

Quick facts

Lead sponsor	Universidad Nacional de Educación a Distancia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	15 November 2019
Primary completion	30 June 2023
Estimated completion	30 September 2023
Sites	1 location across Spain

Drugs / interventions tested

• The AMTE protocol

Conditions studied

• Anxiety Disorder — all drugs for Anxiety Disorder →
• Depressive Disorder — all drugs for Depressive Disorder →
• Emotional Disorder — all drugs for Emotional Disorder →

Sponsor

Universidad Nacional de Educación a Distancia

Who can join

Adults 12 to 18, any sex, with Anxiety Disorder or Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study represents the first research program to assess the efficacy of transdiagnostic cognitive behavior therapy (T-CBT) delivered via internet for anxiety and depression in adolescents. The primary aim of the study was to implement the program AMTE (Aprende a Manejar tus Emociones \[Learn to Manage Your Emotions\]), an internet delivered T-CBT protocol designed to target both anxiety and depression symptoms and disorders (major depression disorder, dysthymic disorder, panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) in adolescents, and to establish its preliminary efficacy on anxiety and depressive symptomatology. A secondary objective is to demonstrate its potential effect regarding: (a) transdiagnostic measures associated with etiology of emotional disorders including negative affect, anxiety sensitivity, and emotional avoidance, and (b) positive factors including satisfaction with life and positive affect. It is expected that the T-CBT condition will be more effective than the waitlist (WL) control group on the primary (anxiety and depression) and secondary (transdiagnostic and positive factors) outcome measures.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Sandín B, García-Escalera J, Valiente RM, Espinosa V, et al · · 2020 · cited 28× · PMID 33182711 · DOI 10.3390/ijerph17228306
2. Prevention of Depression and Anxiety in Subclinical Adolescents: Effects of a Transdiagnostic Internet-Delivered CBT Program.
   Schmitt JC, Valiente RM, García-Escalera J, Arnáez S, et al · · 2022 · cited 23× · PMID 35564759 · DOI 10.3390/ijerph19095365
3. Efficacy of an internet-based version of the unified protocol for transdiagnostic treatment of emotional disorders in adolescents (iUP-A): A randomized active-controlled trial.
   Sandín B, Valiente RM, Arnáez S, García-Escalera J, et al · · 2026 · PMID 42064367 · DOI 10.1016/j.invent.2026.100948