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Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

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…

ClinicalTrials.gov IDNCT06724666
PhaseNA
Enrollment198
SponsorBabes-Bolyai University
Age13 Years
SexALL
I'm interested View official listing

Conditions studied

Anxiety Disorders, Depressive Disorder, Social Anxiety Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder

About this study

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.

Interventions

Primary outcomes

Eligibility information

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 locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.