Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Babes-Bolyai University198 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

198

Conditions

Anxiety Disorders Depressive Disorder Social Anxiety Disorder

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts