Internet-based treatment for anxiety and depression in adolescents

Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

This study is testing an online treatment for anxiety and depression in Romanian teenagers aged 13-17 to see if it helps them feel better and to find out which teens are most likely to benefit from it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 13 Years to 17 Years
• Sex: All
• Sponsor: Babes-Bolyai University (other)
• Locations: 2 sites (Cluj-Napoca and 1 other locations)
• Trial ID: NCT06724666 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a transdiagnostic Internet-delivered intervention for Romanian adolescents suffering from anxiety and depression. Participants aged 13-17 will undergo non-invasive fMRI scans to assess brain signal variability before being assigned to either the intervention or a control group. The study will also investigate the accuracy of a prediction model to determine which adolescents are likely to respond positively to the treatment. This is the first trial of its kind focusing on this demographic and utilizing fMRI data for treatment prediction.

Who should consider this trial

Good fit: Ideal candidates are Romanian adolescents aged 13-17 with elevated symptoms of anxiety or depression and a primary diagnosis of an anxiety or depressive disorder.

Not a fit: Patients with severe mental disorders, active suicidal ideation, or those currently undergoing other forms of therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide an accessible and effective treatment option for adolescents struggling with anxiety and depression.

How similar studies have performed: While this approach is novel in its use of fMRI for predicting treatment response, similar Internet-delivered interventions have shown promise in other populations.

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

Where this trial is running

Cluj-Napoca and 1 other locations

• Babes-Bolyai University — Cluj-Napoca, Romania (NOT_YET_RECRUITING)
• Babeș-Bolyai University — Cluj-Napoca, Romania (RECRUITING)

Study contacts

• Study coordinator: Kristoffer Mansson, PhD

Conditions: Anxiety Disorders, Depressive Disorder, Social Anxiety Disorder, Major Depressive Disorder, Dysthymia, Generalized Anxiety Disorder, Internet-delivered intervention, transdiagnostic