An interventional study of Transdiagnostic Internet-delivered intervention in Anxiety Disorders, Depressive Disorder and Social Anxiety Disorder, sponsored by Babes-Bolyai University. Recruiting at 2 sites in Romania. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Treatment
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:
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 198 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Babes-Bolyai University is the lead sponsor of 48 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT).
Behavioral: Transdiagnostic Internet-delivered intervention
Participants in the control group are a delayed intervention group (waiting list control). They will access the intervention after 8 weeks.
The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.
Internalizing problems
Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents.
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Clinical diagnosis
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
Time frame: administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention
Global functioning
Children's Global Assessment Scale (C-GAS)
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Severity
Clinical Global Impression Scale - Severity
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Improvement
Clinical Global Impression Scale - Improvement
Time frame: after 8 weeks of intervention, 6 months follow-up
Comorbid problems
Subscales of the Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Life satisfaction
SWLS-C: Satisfaction with Life Scale for Children
Time frame: baseline, after 8 weeks of intervention, 6 months follow-up
Satisfaction with the Internet-delivered intervention
Client Satisfaction Questionnaire (CSQ-8)
Time frame: after 8 weeks of intervention
Working alliance
Working alliance scale for Internet interventions
Time frame: after 8 weeks of intervention
Automatic thoughts
Automatic thoughts questionnaire
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Credibility and expectations
Credibility and expectations questionnaire
Time frame: week 2
Credibility and expectations based on primary outcome measure
Credibility and expectations based on primary outcome scale
Time frame: baseline
Anxiety and depressive symptoms
PHQ4
Time frame: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up
Avoidance
CAMS
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Parental distress
DASS-21
Time frame: baseline
Adolescent anxiety and depressive symptoms as reported by parents
RCADS-47 parent report
Time frame: baseline, after 8 weeks of intervention, 6 month follow-up
Parental accommodations
Family accommodation scale - parent report
Time frame: baseline
Plan to share: Yes — Deidentified individual participant data will be will be shared after the publication of the results.
Supporting information: Study protocol, Sap, Icf, Analytic code
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Babes-Bolyai University