| CTRI Number |
CTRI/2025/04/084431 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed method |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the severity of stress and stigma among the caregivers of patient with mental illness and thereby it helps to reduce their stress. |
|
Scientific Title of Study
|
Perceived stigma and psychological distress among the family members of patients with mental illness- A mixed method approach |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SNEHA P |
| Designation |
MSc Nursing |
| Affiliation |
Yenepoya Nursing College |
| Address |
MSc Nursing
Department of Mental Health Nursing
Yenepoya Nursing College
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8606114483 |
| Fax |
|
| Email |
snehakukoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binsha Pappachan C |
| Designation |
HOD and Professor |
| Affiliation |
Yenepoya Nursing College |
| Address |
HOD and Professor
Department of Mental Health Nursing
Yenepoya Nursing College
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964340783 |
| Fax |
|
| Email |
binshadennis83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binsha Pappachan C |
| Designation |
HOD and Professor |
| Affiliation |
Yenepoya Nursing College |
| Address |
HOD and Professor
Department of Mental Health Nursing
Yenepoya Nursing College
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964340783 |
| Fax |
|
| Email |
binshadennis83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital, Deralakatte, Mangaluru, Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil K SNEHA P |
Seminar room Psychiatric Ward Yenepoya Medical College Hospital |
Psychiatric Ward Yenepoya Medical College Hospital
Deralakatte, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA |
8606114483
snehakukoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of patient with mental illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Family members of patients with mental illness who is residing with the patient more than 2 years |
|
| ExclusionCriteria |
| Details |
With psychiatric illness
Who is having physical or intellectual disabilities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Helps to ventilate feelings. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Helps them to cope up |
1 week |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
28/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/04/2025 |
| 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)
|
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
|
A mixed method study will be conducted to assess the perceived stigma and psychological distress among the family members of patients with mental illness. 59 family members will be selected through non probability purposive sampling technique. No intervention will be provided to the participants. Perceived stigma and psychological distress will be assessed through various tools and as well as in depth interviews will be conducted. |