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Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Recruiting
13-17 years
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • elevated symptoms of anxiety or depression/ internalizing problems (T score> 60) at intake (based on Youth self-report completed by adolescents)
  • primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteria according 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 6 weeks before treatment onset
  • Internet access

Exclusion Criteria:

  • severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)
  • any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, 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 on clinical interview).
  • Current treatment with benzodiazepines

Study details
    Anxiety Disorders
    Depressive Disorder
    Social Anxiety Disorder
    Major Depressive Disorder
    Dysthymia
    Generalized Anxiety Disorder

NCT06724666

Babes-Bolyai University

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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