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Search / Trial NCT06724666

Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Launched by BABES-BOLYAI UNIVERSITY · Dec 5, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Internet Delivered Intervention Transdiagnostic Adolescents Internalizing Anxiety Depression

ClinConnect Summary

This clinical trial is studying a new online program designed to help Romanian teenagers aged 13 to 17 who are experiencing anxiety and depression. The goal is to see how effective this Internet-delivered intervention is in improving their mental health. Researchers will also look at how well they can predict which participants are likely to benefit from the treatment. Before starting the program, teens will participate in a brain scan (fMRI) to help assess their brain's adaptability, which may provide insights into their response to the treatment.

To participate, teens must show signs of anxiety or depression and have a formal diagnosis based on established criteria. They should be able to read and understand Romanian and have reliable internet access. Participants must not be currently taking certain medications or undergoing other mental health treatments. It's important to note that those with severe mental health issues or certain other conditions may not be eligible. If you think this trial might be right for you or your teen, it could be a valuable opportunity to receive support for managing anxiety and depression.

Gender

ALL

Eligibility criteria

  • 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

About Babes Bolyai University

Babes-Bolyai University, a prestigious institution located in Cluj-Napoca, Romania, is dedicated to advancing research and innovation in various fields, including healthcare. With a strong emphasis on interdisciplinary collaboration, the university engages in cutting-edge clinical trials aimed at improving patient outcomes and enhancing medical knowledge. Leveraging a robust network of experts and state-of-the-art facilities, Babes-Bolyai University is committed to conducting high-quality research that adheres to ethical standards and contributes to the global scientific community. Through its clinical trial initiatives, the university seeks to foster advancements in treatment methodologies and promote evidence-based practices in medicine.

Locations

Cluj Napoca, , Romania

Cluj Napoca, , Romania

Patients applied

0 patients applied

Trial Officials

Costina Poetar, PhD

Study Chair

Babeș-Bolyai University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported