RecruitingNot ApplicableNCT06724666

Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression


Sponsor

Babes-Bolyai University

Enrollment

198 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 13 YearsMax Age: 17 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

Interventions

BEHAVIORALTransdiagnostic Internet-delivered intervention

The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.


Locations(2)

Babes-Bolyai University

Cluj-Napoca, Romania

Babeș-Bolyai University

Cluj-Napoca, Romania

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06724666


Related Trials