Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

NCT06724666 | Recruiting

• 1 other identifier: PNRR-III-C9-2022-I8-CF278
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety Disorders; Depressive Disorder; Social Anxiety Disorder; Major Depressive Disorder; Dysthymia; Generalized Anxiety Disorder

Keywords

Internet-delivered intervention; transdiagnostic; adolescents; internalizing; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Clinical diagnosis

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

• Global functioning

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

• Severity

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

• Improvement

  after 8 weeks of intervention, 6 months follow-up

• Comorbid problems

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

Study Arms (2)

Transdiagnostic Internet-delivered intervention

EXPERIMENTAL

The intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT).

Behavioral: Transdiagnostic Internet-delivered intervention

Control group

NO INTERVENTION

Participants in the control group are a delayed intervention group (waiting list control). They will access the intervention after 8 weeks.

Interventions

Transdiagnostic Internet-delivered intervention BEHAVIORAL

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

Transdiagnostic Internet-delivered intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (2)

Babes-Bolyai University

Cluj-Napoca, 400015, Romania

NOT YET RECRUITING

Babeș-Bolyai University

Cluj-Napoca, 400015, Romania

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder; Phobia, Social; Depressive Disorder, Major; Dysthymic Disorder; Generalized Anxiety Disorder; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders; Phobic Disorders; Behavioral Symptoms; Behavior

Study Officials

• Costina Poetar, PhD

  Babeș-Bolyai University

  STUDY CHAIR

Central Study Contacts

Kristoffer Mansson, PhD

CONTACT

+46705803267; nils.mansson@ubbcluj.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 9, 2024
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Supporting information will be shared after the publication of the results.
• Access Criteria: Supporting information will be publicly shared in OSF.

Locations

RO (2)