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CTRI Number  CTRI/2023/12/060826 [Registered on: 27/12/2023] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on Mental Health Literacy among the rural Santhal tribe in Hooghly District West Bengal 
Scientific Title of Study   A study on Mental Health Literacy (MHL) among the rural Santhal tribe in Hooghly District West Bengal  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreyasi Gupta 
Designation  Master of Public Health Student 
Affiliation  Prasanna School of Public Health 
Address  Room number 50 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  8697614287  
Fax    
Email  shreyasigupta304@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varalakshmi Chandra Sekaran 
Designation  Associate Professor 
Affiliation  Prasanna School of Public Health 
Address  Room number 50 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9535810325  
Fax    
Email  varalakshmi.cs@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Varalakshmi Chandra Sekaran 
Designation  Associate Professor 
Affiliation  Prasanna School of Public Health 
Address  Room number 50 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi


KARNATAKA
576104
India 
Phone  9535810325  
Fax    
Email  varalakshmi.cs@manipal.edu  
 
Source of Monetary or Material Support  
Institution- Prasanna School of Public Health MAHE Manipal with Self-Funding for PG Thesis 
 
Primary Sponsor  
Name  Dr Shreyasi Gupta 
Address  Master of Public Health Student Room 50 Department of Health Policy Prasanna School of Public Health Manipal Academy of Higher Education Manipal Udupi Karnataka 576104 
Type of Sponsor  Other [self funded] 
 
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 
Dr Varalakshmi Chandra Sekaran  Prasanna School of Public Health  Room Number 50 Department of Health Policy
Udupi
KARNATAKA 
9535810325

varalakshmi.cs@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The study will include the Santhal tribal population of Hooghly district aged 18 years
and above, who are willing to participate. 
 
ExclusionCriteria 
Details  Those who have been previously diagnosed with mental health conditions
Those who are seriously ill or incapacitated 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The aim is to provide insight into the MHL levels within the Santhal community in West Bengal These measures will include evaluating participants knowledge of mental health concepts and attitudes towards mental health help seeking behavior and the cultural adaptation of mental health information
The study aims to provide a comprehensive understanding of the mental health literacy levels within the Santhal community 
12 weeks from the commence of data collection 
 
Secondary Outcome  
Outcome  TimePoints 
A report will be submitted to Tribal Development Department on their current awareness & perceptions related to mental health. This can serve as a foundation for fostering comprehensive & culturally sensitive mental health policies that address the well-being of the Santhal community.  At the end of the study analysis in June
6 months from commence of data collection 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   01/01/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  
Aim
The study aims to assess mental health literacy levels and their determinants among the Santhal tribe
It will also assess attitudes and beliefs towards help-seeking for mental health conditions among the Santhal tribe

Outcome
  • These measures will include evaluating participants knowledge of mental health concepts attitudes towards mental health help-seeking behavior and the cultural adaptation of mental health information
  • It will provide a comprehensive understanding of the mental health literacy levels within the Santhal community shedding light on their current awareness and perceptions related to mental health
  • These measures will be instrumental in providing recommendations to improve mental health
Approvals
 Permission is obtained from the Department of Tribal Welfare the CMOH of the district concerned and consent from the Santhal community leaders and IEC clearance was obtained from Kasturba Medical College/ Kasturba Hospital Institutional Ethics Committee 
Data collection will start after approval from CTRI
 
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