NCT06724666Recruiting
Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 2 Dec 2024
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Babes-Bolyai University
- Diseases
- Depression
- NCT number
- NCT06724666
What you commit to
- Study type: Interventional
- Planned participants: 198
- From 1 Apr 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with benzodiazepines
Other illness
- 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),
- Being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and/or substance dependence disorder, reading disabilities (based on clinical interview).
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Babes-Bolyai University Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.