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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdiagnostic Internet-delivered intervention | Experimental | The intervention consists of 8 modules delivered over 8 weeks. It is based on Rational Emotive Behavioral Therapy (REBT). |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transdiagnostic Internet-delivered intervention | Behavioral | The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristoffer Mansson, PhD | Contact | +46705803267 | nils.mansson@ubbcluj.ro |
| Name | Affiliation | Role |
|---|---|---|
| Costina Poetar, PhD | Babeș-Bolyai University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Babes-Bolyai University | Not yet recruiting | Cluj-Napoca | 400015 | Romania |
Deidentified individual participant data will be will be shared after the publication of the results.
Supporting information will be shared after the publication of the results.
Supporting information will be publicly shared in OSF.
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| Global functioning |
Children's Global Assessment Scale (C-GAS) |
| baseline, after 8 weeks of intervention, 6 months follow-up |
| Severity | Clinical Global Impression Scale - Severity | baseline, after 8 weeks of intervention, 6 months follow-up |
| Improvement | Clinical Global Impression Scale - Improvement | 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 | baseline, after 8 weeks of intervention, 6 month follow-up |
| Life satisfaction | SWLS-C: Satisfaction with Life Scale for Children | baseline, after 8 weeks of intervention, 6 months follow-up |
| Satisfaction with the Internet-delivered intervention | Client Satisfaction Questionnaire (CSQ-8) | after 8 weeks of intervention |
| Working alliance | Working alliance scale for Internet interventions | after 8 weeks of intervention |
| Automatic thoughts | Automatic thoughts questionnaire | baseline, after 8 weeks of intervention, 6 month follow-up |
| Credibility and expectations | Credibility and expectations questionnaire | week 2 |
| Credibility and expectations based on primary outcome measure | Credibility and expectations based on primary outcome scale | baseline |
| Anxiety and depressive symptoms | PHQ4 | baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up |
| Avoidance | CAMS | baseline, after 8 weeks of intervention, 6 month follow-up |
| Parental distress | DASS-21 | baseline |
| Adolescent anxiety and depressive symptoms as reported by parents | RCADS-47 parent report | baseline, after 8 weeks of intervention, 6 month follow-up |
| Parental accommodations | Family accommodation scale - parent report | baseline |
| Babeș-Bolyai University | Recruiting | Cluj-Napoca | 400015 | Romania |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003866 | Depressive Disorder |
| D000072861 | Phobia, Social |
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| D000098647 | Generalized Anxiety Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| D010698 | Phobic Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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