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

April 2, 2025 updated by: Costina-Ruxandra Poetar, Babes-Bolyai University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Romania
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Babes-Bolyai University
      • Cluj-Napoca, Romania, 400015
        • Not yet recruiting
        • Babes-Bolyai University
        • Contact:
        • Contact:
          • Costina R Poetar, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, after 8 weeks of intervention, 6 months follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical diagnosis
Time Frame: 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
administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention
Global functioning
Time Frame: baseline, after 8 weeks of intervention, 6 months follow-up
Children's Global Assessment Scale (C-GAS)
baseline, after 8 weeks of intervention, 6 months follow-up
Severity
Time Frame: baseline, after 8 weeks of intervention, 6 months follow-up
Clinical Global Impression Scale - Severity
baseline, after 8 weeks of intervention, 6 months follow-up
Improvement
Time Frame: after 8 weeks of intervention, 6 months follow-up
Clinical Global Impression Scale - Improvement
after 8 weeks of intervention, 6 months follow-up
Comorbid problems
Time Frame: baseline, after 8 weeks of intervention, 6 month follow-up
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
Time Frame: baseline, after 8 weeks of intervention, 6 months follow-up
SWLS-C: Satisfaction with Life Scale for Children
baseline, after 8 weeks of intervention, 6 months follow-up
Satisfaction with the Internet-delivered intervention
Time Frame: after 8 weeks of intervention
Client Satisfaction Questionnaire (CSQ-8)
after 8 weeks of intervention
Working alliance
Time Frame: after 8 weeks of intervention
Working alliance scale for Internet interventions
after 8 weeks of intervention
Automatic thoughts
Time Frame: baseline, after 8 weeks of intervention, 6 month follow-up
Automatic thoughts questionnaire
baseline, after 8 weeks of intervention, 6 month follow-up
Credibility and expectations
Time Frame: week 2
Credibility and expectations questionnaire
week 2
Credibility and expectations based on primary outcome measure
Time Frame: baseline
Credibility and expectations based on primary outcome scale
baseline
Anxiety and depressive symptoms
Time Frame: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up
PHQ4
baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up
Avoidance
Time Frame: baseline, after 8 weeks of intervention, 6 month follow-up
CAMS
baseline, after 8 weeks of intervention, 6 month follow-up
Parental distress
Time Frame: baseline
DASS-21
baseline
Adolescent anxiety and depressive symptoms as reported by parents
Time Frame: baseline, after 8 weeks of intervention, 6 month follow-up
RCADS-47 parent report
baseline, after 8 weeks of intervention, 6 month follow-up
Parental accommodations
Time Frame: baseline
Family accommodation scale - parent report
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Babes-Bolyai University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Costina Poetar, PhD, Babes-Bolyai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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