| 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 |
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Type of Study
|
Correlational study |
| Study Design |
Other |
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Public Title of Study
|
Understanding the Needs, Coping abilities and challenges faced by caregivers of individuals having Mental illness. |
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Scientific Title of Study
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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 |
|
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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 |
|
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Source of Monetary or Material Support
|
| Kasturba Hospital, Madhav Nagar, Manipal, 576104, Karnataka, India |
|
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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 ] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
caregivers of persons with mental illness
|
|
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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
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 |
|
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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" |
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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 personsith 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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