Anxiety Disorders, Depressive Disorder, Dysthymia, Generalized Anxiety Disorder, Major Depressive Disorder, Social Anxiety Disorder
Conditions
Keywords
Internet-delivered intervention, transdiagnostic, adolescents, internalizing, anxiety, depression
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.
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
BEHAVIORALTransdiagnostic Internet-delivered intervention
The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.
Sponsors
Babes-Bolyai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internalizing problems | baseline, after 8 weeks of intervention, 6 months follow-up | Change from baseline in internalizing problems. Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depressive symptoms | baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up | PHQ4 |
| Avoidance | baseline, after 8 weeks of intervention, 6 month follow-up | CAMS |
| Parental distress | baseline | DASS-21 |
| Adolescent anxiety and depressive symptoms as reported by parents | baseline, after 8 weeks of intervention, 6 month follow-up | RCADS-47 parent report |
| Clinical diagnosis | administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention | 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 |
| Global functioning | baseline, after 8 weeks of intervention, 6 months follow-up | Children's Global Assessment Scale (C-GAS) |
| Severity | baseline, after 8 weeks of intervention, 6 months follow-up | Clinical Global Impression Scale - Severity |
| Credibility and expectations based on primary outcome measure | baseline | Credibility and expectations based on primary outcome scale |
| Comorbid problems | baseline, after 8 weeks of intervention, 6 month follow-up | Subscales of the Revised Children's Anxiety and Depression Scale (RCADS) completed by adolescents |
| Life satisfaction | baseline, after 8 weeks of intervention, 6 months follow-up | SWLS-C: Satisfaction with Life Scale for Children |
| Satisfaction with the Internet-delivered intervention | after 8 weeks of intervention | Client Satisfaction Questionnaire (CSQ-8) |
| Working alliance | after 8 weeks of intervention | Working alliance scale for Internet interventions |
| Automatic thoughts | baseline, after 8 weeks of intervention, 6 month follow-up | Automatic thoughts questionnaire |
| Credibility and expectations | week 2 | Credibility and expectations questionnaire |
| Parental accommodations | baseline | Family accommodation scale - parent report |
| Improvement | after 8 weeks of intervention, 6 months follow-up | Clinical Global Impression Scale - Improvement |
Countries
Romania
Contacts
Primary ContactKristoffer Mansson, PhD
Outcome results
None listed