Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Not Applicable

Recruiting

• Conditions: Anxiety Disorders; Depressive Disorder; Social Anxiety Disorder; Major Depressive Disorder; Dysthymia; Generalized Anxiety Disorder

• Registration Number: NCT06724666
• Lead Sponsor: Babes-Bolyai University

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.

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-09
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Internalizing problems	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 Outcome Measures

Name	Time	Method
Clinical diagnosis	administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention	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
Global functioning	baseline, after 8 weeks of intervention, 6 months follow-up	Children's Global Assessment Scale (C-GAS)
Severity	baseline, after 8 weeks of intervention, 6 months follow-up	Clinical Global Impression Scale - Severity
Improvement	after 8 weeks of intervention, 6 months follow-up	Clinical Global Impression Scale - Improvement
Comorbid problems	baseline, after 8 weeks of intervention, 6 month follow-up	Subscales of the Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents
Life satisfaction	baseline, after 8 weeks of intervention, 6 months follow-up	SWLS-C: Satisfaction with Life Scale for Children
Satisfaction with the Internet-delivered intervention	after 8 weeks of intervention	Client Satisfaction Questionnaire (CSQ-8)
Working alliance	after 8 weeks of intervention	Working alliance scale for Internet interventions
Automatic thoughts	baseline, after 8 weeks of intervention, 6 month follow-up	Automatic thoughts questionnaire
Credibility and expectations	week 2	Credibility and expectations questionnaire
Credibility and expectations based on primary outcome measure	baseline	Credibility and expectations based on primary outcome scale
Anxiety and depressive symptoms	baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up	PHQ4
Avoidance	baseline, after 8 weeks of intervention, 6 month follow-up	CAMS
Parental distress	baseline	DASS-21
Adolescent anxiety and depressive symptoms as reported by parents	baseline, after 8 weeks of intervention, 6 month follow-up	RCADS-47 parent report
Parental accommodations	baseline	Family accommodation scale - parent report

Trial Locations

Locations (2)

Babeș-Bolyai University; 🇷🇴 Cluj-Napoca, Romania

Babes-Bolyai University; 🇷🇴 Cluj-Napoca, Romania