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CTRI Number  CTRI/2024/04/065520 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Expressed emotion assessment scale in Hindi  
Scientific Title of Study   IMH Rohtak Family Attitude Assessment Scale 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhupendra Singh 
Designation  Assistant Professor of Psychiatric Social Work 
Affiliation  Institute of Mental Health, UHS. Rohtak 
Address  Institute of Mental Health
Pt. B D Sharma University of Health Sciences, Rohtak, Haryana, 124001
Rohtak
HARYANA
124001
India 
Phone  9355632839  
Fax    
Email  33bhupendrasingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhupendra Singh 
Designation  Assistant Professor of Psychiatric Social Work 
Affiliation  Institute of Mental Health, UHS. Rohtak 
Address  Institute of Mental Health
Pt. B D Sharma University of Health Sciences, Rohtak, Haryana, 124001
Rohtak
HARYANA
124001
India 
Phone  9355632839  
Fax    
Email  33bhupendrasingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhupendra Singh 
Designation  Assistant Professor of Psychiatric Social Work 
Affiliation  Institute of Mental Health, UHS. Rohtak 
Address  Institute of Mental Health
Pt. B D Sharma University of Health Sciences, Rohtak, Haryana, 124001
Rohtak
HARYANA
124001
India 
Phone  9355632839  
Fax    
Email  33bhupendrasingh@gmail.com  
 
Source of Monetary or Material Support  
Institute of Mental Health, Pt BD Sharma University of Health Sciences, Rohtak 
 
Primary Sponsor  
Name  Institute of Mental Health 
Address  Institute of Mental Health, Pt BD Sharma University of Health Sciences, Rohtak 
Type of Sponsor  Government medical college 
 
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 bhupendra Singh  Pt BD SHARMA PGIMS Rohtak Haryana  Institute of Mental Health, Pt. B D Sharma University of Health Sciences
Rohtak
HARYANA 		 9355632839

33bhupendrasingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt. B D Sharma PGIMS/UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers/ Family Members of Individuals suffering with Mental and Behavioral Disorders 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult Patient diagnosed with mental and bevioral disorders along with their key/ cheif caregivers 
 
ExclusionCriteria 
Details  Caregivers providing care for more than one patient and/or havning any Mental and Behavioral Disorders or Chronic Physical illness 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Avalability of Expressed Emotion Assessment scale in Hindi  at the baseline and six months 
 
Secondary Outcome  
Outcome  TimePoints 
Easy assessment of Expressed Emotion will help in Management   at the baseline & six months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/05/2024 
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)  Open to Recruitment 
Publication Details   NIL 
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 - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 01-01-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - None
Brief Summary
Modification(s)  		 Expressed emotion is a pathological emotional state of caregivers that hinder individuals recovery. This Resaerch will be able to produce an valid Hindi Expressed Emotion Scale for it assessment that will help in easy identification so that its management can be planed.   
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