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CTRI Number  CTRI/2025/10/096601 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Correlational study 
Study Design  Other 
Public Title of Study   Understanding the Needs, Coping abilities and challenges faced by caregivers of individuals having Mental illness. 
Scientific Title of Study   A Correlational study to assess perceived needs, resilience, and burden among caregivers of persons with mental illness in selected hospitals of Udupi district, Karnataka 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Ankita Pal 
Designation  Student 
Affiliation  Manipal College of Nursing, MAHE, Manipal 
Address  Room no 400A, 4th floor, Manipal College of Nursing Building MCON MAHE Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9382052304  
Fax    
Email  pal84204@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Linu Sara George 
Designation  Professor and Head of Department 
Affiliation  Manipal College of Nursing, MAHE, Manipal, Karnataka India 
Address  Room no 302, Third floor, Manipal College of Nursing, MAHE, Manipal,576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845602400  
Fax    
Email  linu.j@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Linu Sara George 
Designation  Professor and Head of Department 
Affiliation  Manipal College of Nursing, MAHE, Manipal, Karnataka India 
Address  Room no 302, Third floor, Manipal College of Nursing, MAHE, Manipal,576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845602400  
Fax    
Email  linu.j@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Madhav Nagar, Manipal, 576104, Karnataka, India 
 
Primary Sponsor  
Name  Ms. Ankita Pal  
Address  Room no 400 A 4th floor Manipal College of Nursing Building, MCON MAHE Manipal,576104, Karnataka, India 
Type of Sponsor  Other [Self Sponsored ] 
 
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 Rajeshkrishna Bhandary P  Kasturba Hospital, Manipal, Karnataka, India  Room no 402, 403,405 and 410, 4th floor, Psychiatric ward, Room no 1, 2, 3, 13 and 14 of Psychiatric OPD, 2nd floor, Baliga Block, Kasturba hospital, Manipal, Madhav Nagar, 576104, Karnataka, India.
Udupi
KARNATAKA 
9844542567

rajesh.kbp@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(Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  caregivers of persons with mental illness  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Primary Caregivers of persons with mental illness in the psychiatric units of the hospital and who are consenting to participate in the study
Caregivers who can read and write kannada and English
Caregivers who are between the age group of 20 to 60 years
Caregivers of both psychotic and Neurotic patients 
 
ExclusionCriteria 
Details  Caregivers who are not the primary caregivers or paid caregivers
Caregivers who are reporting to have mental health issues during data collection
Caregivers of Alcohol dependent syndrome patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore the perceived needs of caregivers using the perceived need assessment checklist.
To assess the level of resilience using Connor-Davidson Resilience Scale (CD-RISC).
To determine the burden among caregivers of persons with mental illness using the Zarit Burden Interview (ZBI).
To investigate the relationship between perceived needs, resilience and burden among caregivers of persons with mental illness. 
The outcome variables will be assessed only once during the study period. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   06/11/2025 
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  

Background of the study

Mental illness is a major global health challenge, affecting nearly one in eight people worldwide. In India, about thirteen to seventeen percentage of the population suffers from mental disorders, with depression and anxiety being the most common. However, seventy to ninety percent of patients remain untreated due to stigma, lack of awareness, and a shortage of mental health professionals. This contributes to high disability, premature mortality, and significant economic losses.

With the shift from institutional to community based care, the responsibility of caring for mentally ill individuals largely falls on family members. Caregivers face significant physical, emotional, and financial strain, with studies reporting that thirty one to thirty eight percentage of caregivers worldwide experience high levels of burden. In India, cultural expectations intensify this burden, often leaving caregivers unsupported despite their critical role.

Resilience is an important protective factor, as higher resilience reduces stress among caregivers. However, many caregivers struggle with unmet needs, including emotional support, financial aid, and respite services. Research gaps remain, as most studies focus on schizophrenia, with less attention to bipolar disorder and depression. Few studies assess caregiver burden, resilience, and perceived needs together, especially in non-Western contexts.

Therefore, studying the resilience, stress, and perceived needs of caregivers of people with mental illness is essential to design targeted interventions that reduce stress, enhance well-being, and improve the quality of care provided.

Statement of the problem         

A Correlational study to assess perceived needs, resilience, and burden among caregivers of persons with mental illness in selected hospitals of Udupi district, Karnataka.

Purpose of the study

The study focuses on assessing what caregivers believe they require to provide effective care to the mentally ill patients, how resilient they are in dealing with their responsibilities, and the burden caregivers’ face while fulfilling their caregiving responsibilities. The findings of the study will help to identify potential interventions or support mechanisms that could help caregivers manage their burden more effectively and enhance their resilience. 

Objectives of the study                                                                                                               

1.      To explore the perceived needs of caregivers using the perceived need assessment checklist.

2.      To assess the level of resilience using Connor-Davidson Resilience Scale (CD-RISC).

3.      To determine the burden among caregivers of persons with mental illness using the Zarit Burden Interview (ZBI).

4.      To investigate the relationship between perceived needs, resilience and burden among caregivers of persons with mental illness.

Hypothesis

 The hypothesis will be tested at 0.05 level of significance.

H1 There will be a significant relationship between perceived needs, resilience and burden experienced by caregivers of persons with mental illness.

Assumptions 

  • Caregivers may express their perceived needs related to caregiving. 
  •  Caregivers may face some amount of Burden during the caregiving process. 
  •  Resilience can reduce the Burden faced by the caregivers. 
  •  Perceived needs among caregivers may influence their level of resilience and burden.
Conceptual Framework
A conceptual framework is a collection of concepts, hypotheses, or models that serve as a map for research. The relationship between perceived needs, resilience and Burden among caregivers will be modified based on “ABCX” model developed by sociologist Reuben Hill. The major components will include the following: Perceived needs, Resilience and Burden i.e. a), b) and c) respectively, leading to X i.e. the outcome. 

RESEARCH METHODOLOGY 
  •  Research approach 
  •  A Quantitative approach will be used to achieve the study objectives. 
  •  Research design  
  •  A Descriptive correlational survey 
  •  Research setting 
  •  Selected hospitals of Udupi district, Karnataka. 
  •  Population 
  •  Caregivers of persons with mental illness in the respective psychiatric units. (Both in-patient and out-patient caregivers)

This Descriptive correlational study will be conducted in the psychiatric wards and OPD of a tertiary hospital in Udupi district, Karnataka from October 2025 to August 2026. A total of 100 caregivers of persons with mental illness meeting the inclusion criteria will be recruited through purposive sampling. Data will be collected using 4 tools, the demographic proforma(self developed), the perceived needs assessment scale(self developed) , Connor Davidson Resilience scale and Zarit Burden Interview scale.

Data will be analysed using descriptive and inferential statistics ( t test, ANOVA, Chi-square, correlational and regression) with Jamovi Software at 5% level of significance. 


 
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