| CTRI Number |
CTRI/2025/09/094592 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Training AI to Screen Mental Health Issues through Voice, Video, and Eye Movements. |
|
Scientific Title of Study
|
Developing Machine Learning Multi-Model Screening Tools for Mental Health Using
Voice, Video, and Eye-Tracking Data. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JCDC/BHRJ25/051 dated 29th July 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
HCJMRI, Department of Growth and Endocrinology, Lower Ground Floor, Block V,
32, Sassoon Road, Jehangir Hospital,
Pune - 411 001.
Pune
MAHARASHTRA
411001
India |
| Phone |
9850244305 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
HCJMRI, Department of Growth and Endocrinology, Lower Ground Floor, Block V,
32, Sassoon Road, Jehangir Hospital,
Pune - 411 001.
Pune
MAHARASHTRA
411001
India |
| Phone |
9850244305 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Khadilkar |
| Designation |
Deputy Director |
| Affiliation |
Hirabai Cowasji Jehangir Medical Research Institute |
| Address |
HCJMRI, Department of Growth and Endocrinology, Lower Ground Floor, Block V,
32, Sassoon Road, Jehangir Hospital,
Pune - 411 001.
Pune
MAHARASHTRA
411001
India |
| Phone |
9850244305 |
| Fax |
|
| Email |
anuradhavkhadilkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tllid India Private Limited, G 903 Orchid Woods, Hennur Road,
Bangalore, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Tllid India Private Limited |
| Address |
G-903 Orchid Woods, Hennur Road,
Bangalore, Karnataka, India |
| Type of Sponsor |
Other [Mental Healthcare Institution] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuradha Khadilkar |
Hirabai Cowasji Jehangir Medical Research Institute |
Block V Lower Basement, Jehangir Hospital, 32 Sassoon Road, Pune Station, Pune 411001
Pune
MAHARASHTRA |
98502 44305
anuradhavkhadilkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental health issues such as depression, anxiety, stress, and burnout. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Able to read and understand English and also understand a supported Indian language
2. Willing to participate in audio, video, and eye-tracking based tasks
3. Capable of providing informed consent (or assent with parental/guardian consent if below 18)
4. Comfortable using or being guided through digital tools (e.g., tablets, computers) |
|
| ExclusionCriteria |
| Details |
1. Currently undergoing psychiatric emergency treatment
2. Have severe cognitive, speech, or visual impairments that interfere with their ability to complete the tasks
3. Have any condition that, in the judgment of the investigator, would make participation unsafe or unsuitable |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinically train a multimodal AI model that assesses mental well-being through non-invasive analysis of voice biomarkers, facial microexpressions, and eye gaze movement. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
29/09/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
This research aims to clinically validate a novel artificial intelligence based tool designed to screen for mental wellness indicators such as stress, anxiety, depression, burnout, and resilience. The tool leverages non-invasive multimodal data including voice patterns, facial microexpressions, and eye movements to assess psychological well-being. The primary objective is to develop an explainable, culturally relevant, and clinically reliable digital screening model specifically tailored to the Indian population. This AI tool is envisioned to facilitate early identification and timely intervention in mental health care by offering an accessible, scalable, and user-friendly technological solution. The study will adopt a cross-sectional observational design to collect and analyze multimodal biometric data from consenting participants aged between 14 to 65 years. Data collection will involve non-invasive audio and video recordings during guided psychological tasks, alongside psychological assessments using gold-standard questionnaires and clinical observations. It is important to note that the model is intended as a screening and well-being support tool and is not a substitute for clinical diagnosis. |