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CTRI Number  CTRI/2023/12/060582 [Registered on: 20/12/2023] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Caregiver burden in adult caregivers of elderly with psychiatric disorders  
Scientific Title of Study   “What is the impact of looking after elderly with psychiatric disorders?”- A cross-sectional study to evaluate caregiver burden, coping and resilience in adult caregivers of elderly with psychiatric disorders.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharanya Mohan 
Designation  Junior Resident 
Affiliation  St. Johns Medical College and Hospital 
Address  St. John’s Medical College and Hospital, Sarjapur Road
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore- 560034, Karnataka, India.
Bangalore
KARNATAKA
560034
India 
Phone  8762172063  
Fax    
Email  sharanyamohan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priya Sreedaran 
Designation  Associate Professor 
Affiliation  St. Johns Medical College and Hospital 
Address  St. John’s Medical College and Hospital, Sarjapur Road, Bangalore
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore- 560034, Karnataka, India.
Bangalore
KARNATAKA
560034
India 
Phone  9916043454  
Fax    
Email  drpriyasreedaran@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sharanya Mohan 
Designation  Junior Resident 
Affiliation  St. Johns Medical College and Hospital 
Address  St. John’s Medical College and Hospital, Sarjapur Road, Bangalore
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore- 560034, Karnataka, India.
Bangalore
KARNATAKA
560034
India 
Phone  8762172063  
Fax    
Email  sharanyamohan@gmail.com  
 
Source of Monetary or Material Support  
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore- 560034, Karnataka, India. 
 
Primary Sponsor  
Name  Dr. Sharanya Mohan 
Address  St. Johns Medical College and Hospital 
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharanya Mohan  St. Johns Medical College and Hospital  General Medicine Common wards, Department of General Medicine, B block, 3rd Floor, St. John’s Medical College Hospital, Sarjapur Road Bangalore - 560 034, India
Bangalore
KARNATAKA 		 8762172063

sharanyamohan@gmail.com 
Dr Sharanya Mohan  St. Johns Community Health Training Centre  St. Johns Community Health Training Centre, Mugalur Village, Karnataka
Bangalore Rural
KARNATAKA 		 8762172063

sharanyamohan@gmail.com 
Dr Sharanya Mohan  St. Johns Medical College and Hospital  Psychiatry Common ward, Department of Psychiatry, B block, 2nd Floor, St. John’s Medical College Hospital, Sarjapur Road Bangalore - 560 034, India
Bangalore
KARNATAKA 		 8762172063

sharanyamohan@gmail.com 
Dr Sharanya Mohan  St. Johns Medical College and Hospital  Psychiatry Private ward, Department of Psychiatry, A block, 1st Floor- Rear, St. John’s Medical College Hospital, Sarjapur Road Bangalore - 560 034, India
Bangalore
KARNATAKA 		 8762172063

sharanyamohan@gmail.com 
Dr Sharanya Mohan  St. Johns Medical College and Hospital  Psychiatry OPD- Room Number 25, Out Patient Block, St. Johns Medical College and Hospital, Sarjapur Road Bangalore - 560 034, India
Bangalore
KARNATAKA 		 8762172063

sharanyamohan@gmail.com 
Dr Sharanya Mohan  St. Johns Medical College and Hospital  Endocrinology Common ward, Department of Endocrinology, B block, 4th Floor, St. John’s Medical College Hospital, Sarjapur Road Bangalore - 560 034, India
Bangalore
KARNATAKA 		 8762172063

sharanyamohan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St. Johns Medical College, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary caregivers of patients, 18 years and above, without dementia or any symptomatic psychiatric illnes. 
Patients  (1) ICD-10 Condition: F20||Schizophrenia, (2) ICD-10 Condition: F25||Schizoaffective disorders, (3) ICD-10 Condition: F31||Bipolar disorder, (4) ICD-10 Condition: F32||Major depressive disorder, singleepisode, (5) ICD-10 Condition: F33||Major depressive disorder, recurrent, (6) ICD-10 Condition: F42||Obsessive-compulsive disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Elderly patients
1. Age 60 years and above
2. Diagnosed with schizophrenia, bipolar affective disorder, severe depression, schizoaffective disorder, OCD.

Primary caregivers
1) Adult caregivers (18 years and above)
 
 
ExclusionCriteria 
Details  Elderly patients
1. With dementia
2. With delirium
3. With bowel and bladder incontinence
4. With terminal medical illness (patients with history of stroke with no motor deficits will be taken)

Primary caregivers
1. With dementia (will be screened if aged 65 years or more)
2.Caregivers who have a diagnosed primary severe psychiatric illness and are currently symptomatic (those in remission for more than 6 months will be included)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Zarit Burden Interview Score  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Coping Strategies Scale score  At baseline 
Connor-Davidson Resilience scale (CD-RISC 25) score  At baseline 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   30/12/2023 
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="2"
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  

In the elderly with severe mental illness, caregiving is often prolonged and challenging and can cause a significant burden on caregivers. While there are many studies examining caregiver burden among elderly with dementia, the literature on the impact of providing care to elderly with psychiatric disorders is inadequate. In this cross-sectional study, we aim to evaluate the caregiver burden in caregivers of elderly with psychiatric disorders, their coping mechanisms and resilience among them. Understanding the various aspects of distress related to caregiving among primary caregivers of elderly with psychiatric disorders, their resilience, as well as coping strategies will provide information on the needs of these caregivers. This will in turn enable development of services to support them better, and can contribute to better care of elderly with psychiatric disorders. 

 
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