Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression (NEURO4C)

Babes-Bolyai University

Status

Enrolling

Conditions

Major Depressive Disorder

Dysthymia

Generalized Anxiety Disorder

Social Anxiety Disorder

Anxiety Disorders

Depressive Disorder

Treatments

Behavioral: Transdiagnostic Internet-delivered intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06724666

PNRR-III-C9-2022-I8-CF278

Details and patient eligibility

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.

Full 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.

Enrollment

198 estimated patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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