Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
Recruiting · NCT06724666 · Interventional (participants receive a specific treatment) · Lead sponsor: Babes-Bolyai University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed.
- Babes-Bolyai University - Cluj-Napoca, Romania
- Babeș-Bolyai University - Cluj-Napoca, Romania