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NCT Number: NCT06724666

Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

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.

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Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Dysthymia Dysthymic Disorder Generalized Anxiety Disorder Major Depressive Disorder Mental Disorders Mood Disorders Phobia, Social Phobic Disorders Social Anxiety Disorder

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University, Cluj-Napoca, Romania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdiagnostic Internet-delivered intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Global functioning

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

    Children's Global Assessment Scale (C-GAS)

  3. Severity

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

    Clinical Global Impression Scale - Severity

  4. Improvement

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

    Clinical Global Impression Scale - Improvement

  5. 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

  6. Life satisfaction

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

    SWLS-C: Satisfaction with Life Scale for Children

  7. Satisfaction with the Internet-delivered intervention

    Time frame: after 8 weeks of intervention

    Client Satisfaction Questionnaire (CSQ-8)

  8. Working alliance

    Time frame: after 8 weeks of intervention

    Working alliance scale for Internet interventions

  9. Automatic thoughts

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

    Automatic thoughts questionnaire

  10. Credibility and expectations

    Time frame: week 2

    Credibility and expectations questionnaire

  11. Credibility and expectations based on primary outcome measure

    Time frame: baseline

    Credibility and expectations based on primary outcome scale

  12. Anxiety and depressive symptoms

    Time frame: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up

    PHQ4

  13. Avoidance

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

    CAMS

  14. Parental distress

    Time frame: baseline

    DASS-21

  15. 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

  16. Parental accommodations

    Time frame: baseline

    Family accommodation scale - parent report

Study contacts

Contact information is provided by the study sponsor or research team.

Kristoffer Mansson, PhD

CONTACT

[email protected]

+46705803267

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Acronym: NEURO4C

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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