Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Last updated: April 2, 2025
Sponsor: Babes-Bolyai University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Depression

Social Phobia

Treatment

Transdiagnostic Internet-delivered intervention

Clinical Study ID

NCT06724666
PNRR-III-C9-2022-I8-CF278
  • Ages 13-17
  • All Genders

Study Summary

The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are:

  • What is the clinical efficacy of the Internet-delivered intervention?

  • How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • elevated symptoms of anxiety or depression/ internalizing problems (T score> 60) atintake (based on Youth self-report completed by adolescents)

  • primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteriaaccording to ADIS-5-C/P interview

  • age 13-17

  • able to read and understand Romanian language

  • Currently unmedicated or on stable and adequate doses of medication for at least 6weeks before treatment onset

  • Internet access

Exclusion

Exclusion Criteria:

  • severe mental disorder (psychosis, severe depression, bipolar disorder, based onclinical interview)

  • any condition that interferes with the protocol implementation (e.g., physicalillness or sensory impairment that interferes with behavioral tasks such asexposure, behavioral activation, unavailable for the next 3 months),

  • active suicidal ideation (assessed by child psychiatrist during clinical interview)in the last month

  • currently following CBT/ psychotherapy for anxiety/depression, in the last 6 months

  • fMRI incompatible (based on safety questionnaire)

  • Being diagnosed with an intellectual disability, pervasive developmental disorder,an alcohol and/or substance dependence disorder, reading disabilities (based onclinical interview).

  • Current treatment with benzodiazepines

Study Design

Total Participants: 198
Treatment Group(s): 1
Primary Treatment: Transdiagnostic Internet-delivered intervention
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
June 30, 2026

Study Description

To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.

Connect with a study center

  • Babes-Bolyai University

    Cluj-Napoca, 400015
    Romania

    Site Not Available

  • Babeș-Bolyai University

    Cluj-Napoca, 400015
    Romania

    Active - Recruiting

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