Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorBabes-Bolyai University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transdiagnostic Internet-delivered intervention

    Behavioral

    The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Transdiagnostic Internet-delivered interventionExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Internalizing problems

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

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

Secondary outcomes

1

Clinical diagnosis

Change in DSM-5 Anxiety and Depressive Disorder Diagnoses in Accordance with Anxiety Disorders Interview Schedule for the DSM-5, Child and Parent Versions (ADIS-5-C/P) Clinical Diagnosis

Time frame
administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention
2

Global functioning

Children's Global Assessment Scale (C-GAS)

Time frame
baseline, after 8 weeks of intervention, 6 months follow-up
3

Severity

Clinical Global Impression Scale - Severity

Time frame
baseline, after 8 weeks of intervention, 6 months follow-up
4

Improvement

Clinical Global Impression Scale - Improvement

Time frame
after 8 weeks of intervention, 6 months follow-up

Other outcomes

Sponsors and contacts

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