Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transdiagnostic Internet-delivered intervention.
- Who it may be relevant to
- Registry conditions: Anxiety Disorders, Depressive Disorder, Social Anxiety Disorder, Major Depressive Disorder. Basic parameters: 13 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Behavioral Transdiagnostic Internet-delivered intervention
The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.
Primary outcome measures
- Internalizing problems [Time frame: baseline, after 8 weeks of intervention, 6 months follow-up]
Secondary outcome measures (12)
- Clinical diagnosis [Time frame: 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]
- Severity [Time frame: baseline, after 8 weeks of intervention, 6 months follow-up]
- Improvement [Time frame: after 8 weeks of intervention, 6 months follow-up]
- Comorbid problems [Time frame: baseline, after 8 weeks of intervention, 6 month follow-up]
- Life satisfaction [Time frame: baseline, after 8 weeks of intervention, 6 months follow-up]
- Satisfaction with the Internet-delivered intervention [Time frame: after 8 weeks of intervention]
- Working alliance [Time frame: after 8 weeks of intervention]
- Automatic thoughts [Time frame: baseline, after 8 weeks of intervention, 6 month follow-up]
- Credibility and expectations [Time frame: week 2]
- Credibility and expectations based on primary outcome measure [Time frame: baseline]
- Anxiety and depressive symptoms [Time frame: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Romania · 2 centers
- Babes-Bolyai University — Cluj-Napoca
- Babeș-Bolyai University — Cluj-Napoca
Identifiers
NCT: NCT06724666 · PNRR-III-C9-2022-I8-CF278