Clinical trial NCT06724666: Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
Official title: Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Social Anxiety Disorder
Major Depressive Disorder
Dysthymia
Generalized Anxiety Disorder
Keywords: Internet-delivered intervention
transdiagnostic
adolescents
internalizing
anxiety
depression
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 198
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Internalizing problems
timeFrame: baseline, after 8 weeks of intervention, 6 months follow-up
Secondary outcomes:
measure: Clinical diagnosis
timeFrame: administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention
measure: Global functioning
timeFrame: baseline, after 8 weeks of intervention, 6 months follow-up
measure: Severity
timeFrame: baseline, after 8 weeks of intervention, 6 months follow-up
measure: Improvement
timeFrame: after 8 weeks of intervention, 6 months follow-up
measure: Comorbid problems
timeFrame: baseline, after 8 weeks of intervention, 6 month follow-up
measure: Life satisfaction
timeFrame: baseline, after 8 weeks of intervention, 6 months follow-up
measure: Satisfaction with the Internet-delivered intervention
timeFrame: after 8 weeks of intervention
measure: Working alliance
timeFrame: after 8 weeks of intervention
measure: Automatic thoughts
timeFrame: baseline, after 8 weeks of intervention, 6 month follow-up
measure: Credibility and expectations
timeFrame: week 2
measure: Credibility and expectations based on primary outcome measure
timeFrame: baseline
measure: Anxiety and depressive symptoms
timeFrame: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up
measure: Avoidance
timeFrame: baseline, after 8 weeks of intervention, 6 month follow-up
measure: Parental distress
timeFrame: baseline
measure: Adolescent anxiety and depressive symptoms as reported by parents
timeFrame: baseline, after 8 weeks of intervention, 6 month follow-up
measure: Parental accommodations
timeFrame: baseline
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
city: Cluj-Napoca
country: Romania
facility: Babeș-Bolyai University
Study officials:
affiliation: Babeș-Bolyai University
name: Costina Poetar, PhD
role: STUDY_CHAIR
References: