NCT06724666 Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
| NCT ID | NCT06724666 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Babes-Bolyai University |
| Condition | Anxiety Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 198 participants in total. It began in 2025-04-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Costina Poetar, PhD
STUDY CHAIR
Babeș-Bolyai University
Frequently Asked Questions
Who can join the NCT06724666 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Anxiety Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06724666 currently recruiting?
Yes, NCT06724666 is actively recruiting participants. Contact the research team at nils.mansson@ubbcluj.ro for enrollment information.
Where is the NCT06724666 trial being conducted?
This trial is being conducted at Cluj-Napoca, Romania, Cluj-Napoca, Romania.
Who is sponsoring the NCT06724666 clinical trial?
NCT06724666 is sponsored by Babes-Bolyai University. The principal investigator is Costina Poetar, PhD at Babeș-Bolyai University. The trial plans to enroll 198 participants.
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