Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Babes-Bolyai University2 sites in 1 country198 target enrollmentApril 1, 2025

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

Overview

Phase: N/A
Intervention: Not specified
Conditions: Anxiety Disorders
Sponsor: Babes-Bolyai University
Enrollment: 198
Locations: 2
Primary Endpoint: Internalizing problems
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.

Registry

clinicaltrials.gov

Start Date

April 1, 2025

End Date

June 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Babes-Bolyai University

Responsible Party

Principal Investigator

Costina-Ruxandra Poetar

Assistant professor

Babes-Bolyai University

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

Outcomes

Primary Outcomes

Internalizing problems

Time Frame: baseline, after 8 weeks of intervention, 6 months follow-up

Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents.

Secondary Outcomes

Clinical diagnosis(administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention)
Global functioning(baseline, after 8 weeks of intervention, 6 months follow-up)
Severity(baseline, after 8 weeks of intervention, 6 months follow-up)
Improvement(after 8 weeks of intervention, 6 months follow-up)
Comorbid problems(baseline, after 8 weeks of intervention, 6 month follow-up)
Life satisfaction(baseline, after 8 weeks of intervention, 6 months follow-up)
Satisfaction with the Internet-delivered intervention(after 8 weeks of intervention)
Working alliance(after 8 weeks of intervention)
Automatic thoughts(baseline, after 8 weeks of intervention, 6 month follow-up)
Credibility and expectations(week 2)
Credibility and expectations based on primary outcome measure(baseline)
Anxiety and depressive symptoms(baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up)
Avoidance(baseline, after 8 weeks of intervention, 6 month follow-up)
Parental distress(baseline)
Adolescent anxiety and depressive symptoms as reported by parents(baseline, after 8 weeks of intervention, 6 month follow-up)
Parental accommodations(baseline)