Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Transdiagnostic Internet-delivered intervention

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

Group Type EXPERIMENTAL

Transdiagnostic Internet-delivered intervention

Intervention Type BEHAVIORAL

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transdiagnostic Internet-delivered intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No