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CTRI Number  CTRI/2025/08/093199 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Using Neurofeedback to Improve Emotional Health in Adolescents with Anxiety and Depression” 
Scientific Title of Study   Study of Neurofeedback Training as an Adjunctive Transdiagnostic Treatment among Adolescents with Internalizing Disorder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Snehaa 
Designation  PhD Scholar 
Affiliation  AIl India Institute of Medical Sciences , New Delhi 
Address  4089, 4th Floor Psychiatry Department, Teaching block , AIIMS , New Delhi

South
DELHI
110029
India 
Phone  9003081821  
Fax    
Email  snehaa.2008@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Sagar 
Designation  Professor 
Affiliation  AIl India Institute of Medical Sciences , New Delhi 
Address  4089, 4th Floor Psychiatry Department, Teaching block , AIIMS , New Delhi

South
DELHI
110029
India 
Phone  9810575310  
Fax    
Email  rsagar29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajesh Sagar 
Designation  Professor 
Affiliation  AIl India Institute of Medical Sciences , New Delhi 
Address  4089, 4th Floor Psychiatry Department, Teaching block , AIIMS , New Delhi

South
DELHI
110029
India 
Phone  9810575310  
Fax    
Email  rsagar29@gmail.com  
 
Source of Monetary or Material Support  
Room number 4089, 4th floor , Teaching Block, AIIMS New Delhi 
 
Primary Sponsor  
Name  Snehaa 
Address  Room number 4089, 4th floor , Teaching Block, AIIMS New Delhi 
Type of Sponsor  Other [Research Fellowship under the institute] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Snehaa  AIl India Institute of Medical Sciences , New Delhi  Room No. 4089, 4th floor, Teaching Block, AIIMS , New DElhi
South
DELHI 		 9003081821

Snehaa.2008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F413||Other mixed anxiety disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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.) Electrode Localization: FCz, Fz, AFz, Cz, & Pz Target Regions: Dorsal Anterior Cingulate Cortex (dACC) and Posterior Cingulate Cortex (PCC), localized via sLORETA and MNI coordinates Session Frequency: 2 sessions per week Session Duration: 30 minutes per session Total Duration: 12 - 15 weeks Feedback Type: Real-time visual feedback based on infra-slow brain activity Participant Instructions: You’ll see a slide on the screen that adapts to your brain signals; I want you to stay in a spot where you feel good and try to maintain it as long as you can 
Comparator Agent  No intervention   Waitlist Control Group: Participants assigned to the comparator arm will be placed on a waitlist and will not receive neurofeedback training during the intervention phase. They will continue with treatment-as-usual (TAU), which may include psychotherapy, pharmacological management, or school-based counselling, as per individual clinical needs. 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.  mid-intervention, 1 week post-intervention and 3-month follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
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.  mid-intervention, 1 week post-intervention and 3-month follow-up 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [snehaa.2008@gmail.com].

  6. For how long will this data be available start date provided 01-11-2027 and end date provided 01-11-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study investigates the efficacy of infra-slow EEG neurofeedback training as an adjunctive transdiagnostic intervention for adolescents diagnosed with internalizing disorders, including anxiety and depression. Utilizing a quasi-experimental pre-test, post-test, and follow-up design, the study aims to evaluate changes in symptom severity and transdiagnostic factors such as emotional regulation, attentional control, and rumination. Participants will be assigned to either an intervention group receiving infra-slow closed-loop neurofeedback targeting the dorsal anterior cingulate cortex (dACC) and posterior cingulate cortex (PCC), or a waitlist control group receiving treatment-as-usual. Neurofeedback sessions will be conducted twice weekly over a defined period, using a 128-channel Geodesic Sensor Net and real-time feedback mechanisms. Outcomes will be assessed using standardized psychometric instruments including the Screen for Child Anxiety Related Emotional Disorders (SCARED), Beck Depression Inventory-II (BDI-II), Difficulties in Emotion Regulation Scale (DERS), and Ruminative Response Scale (RRS), alongside neurophysiological measures derived from EEG source localization. The study seeks to establish neurofeedback as a viable, non-pharmacological adjunct for improving clinical and functional outcomes in adolescents with internalizing disorders. 
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