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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Major Depressive Disorder; Social Anxiety Disorder; Dysthymia
• Intervention / Treatment: Behavioral: Transdiagnostic Internet-delivered intervention

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 Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristoffer Mansson, PhD; Phone Number: +46705803267; Email: nils.mansson@ubbcluj.ro

Study Locations

• Romania
  • Cluj-Napoca, Romania, 400015
    • Recruiting
    • Babes-Bolyai University
  • Cluj-Napoca, Romania, 400015
    • Not yet recruiting
    • Babes-Bolyai University
    • Contact: Costina R Poetar, Ph.D; Phone Number: + 40743589465; Email: costinapoetar@psychology.ro
    • Contact: Costina R Poetar, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdiagnostic Internet-delivered intervention; The intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT).	Behavioral: Transdiagnostic Internet-delivered intervention; The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.
No Intervention: Control group; Participants in the control group are a delayed intervention group (waiting list control). They will access the intervention after 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internalizing problems	Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents.	baseline, after 8 weeks of intervention, 6 months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Investigators: Study Chair: Costina Poetar, PhD, Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: depression; anxiety; adolescents; internalizing; Internet-delivered intervention; transdiagnostic
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Phobic Disorders; Phobia, Social; Anxiety Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Dysthymic Disorder
• Other Study ID Numbers: PNRR-III-C9-2022-I8-CF278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be will be shared after the publication of the results.
• IPD Sharing Time Frame: Supporting information will be shared after the publication of the results.
• IPD Sharing Access Criteria: Supporting information will be publicly shared in OSF.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No