Health Condition 1: F413- Other mixed anxiety disorders
Conditions
Interventions
Intervention1: Infra-slow closed-loop neurofeedback: Modality: Infra-slow EEG neurofeedback (0.0?0.1 Hz)
System: Closed-loop feedback using 128-channel Geodesic Sensor Net (Electrical Geodesics, Inc.
I want you to stay in a spot
where you feel good and try to maintain it as long as you can
Control Intervention1: No intervention: Waitlist Control Group: Participants assigned to the comparator arm w
Sponsors
Snehaa
Eligibility
Inclusion criteria
Inclusion criteria: Age 11 to 17 years Both male and female Adolescents with IQ above 85 (on WISC -IV) Diagnosis of internalizing disorder (CBCL score above 65 in internalizing disorders)in one or more including anxiety disorders (generalised anxiety, social anxiety, separation anxiety and depressive disorders (Major depressive disorders, dysthymia)diagnosed according to ICD -10, and DSM (Additional use of ICD-11) Internalizing disorders comorbid with academic problems and dissociative disorders (T-score above 65 in internalizing disorder measured by CBCL) Participants giving informed assent and consent
Exclusion criteria
Exclusion criteria: History of Organic Psychiatric Diagnosis History of substance use measured by WHO-ASSIST-Y Co-morbid psychiatric diagnosis (except academic problems and dissociative disorders) Secondary diagnosis of depression due to other medical or psychiatric concerns Has current suicidal ideation measured by SIQ History of chronic or other significant general medical or neurological conditions Having physical/sensory disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical outcome will be the change in transdiagnostic internalizing symptom severity, assessed from baseline to post-intervention, using a composite score derived from the Child Behavior Checklist (CBCL), Screen for Child Anxiety Related Disorders (SCARED), and Childhood Depression Inventory-II (CDI-II). These tools will capture a broad spectrum of internalizing symptoms including anxiety, depression, and related behavioral/emotional difficulties, allowing for a robust measure of clinical change across diagnostic boundaries. The primary neural outcome will be the change in the specific neurophysiological marker targeted by neurofeedback ( EEG-derived PCC/dACC activity), measured pre- and post-intervention using standardized acquisition and preprocessing protocols. This will provide a mechanistic indicator of neurofeedback efficacy in modulating relevant brain networks associated with internalizing disorders.Timepoint: mid-intervention, 1 week post-intervention and 3-month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary clinical outcomes will include changes in transdiagnostic process variables such as emotion regulation, rumination, and attentional control, measured using the Difficulties in Emotion Regulation Scale (DERS), Ruminative Response Scale (RRS), and Attentional Control Scale for Children (ACS-C). These measures will allow investigation of potential mediators of clinical change and clarify the pathways through which neurofeedback exerts its effects. Feasibility and acceptability will be assessed through retention, adherence, and participant feedback, while socio-demographic and baseline cognitive functioning (via WISC-IV) will be used to examine potential moderators of treatment response.Timepoint: mid-intervention, 1 week post-intervention and 3-month follow-up | — |
Countries
India
Contacts
Public ContactDr Rajesh Sagar
AIl India Institute of Medical Sciences , New Delhi
Outcome results
None listed