| CTRI Number |
CTRI/2026/02/103798 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Coping intervention to reduce burden of caregiving and improving wellbeing of family members ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Intervention for coping and improving wellbeing of family members of mentally ill patients |
|
Scientific Title of Study
|
Efficacy of coping intervention on subjective burden and wellbeing of family members of chronic mentally ill patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Barnali Mukherjee |
| Designation |
Professor |
| Affiliation |
Health and Family welfare Dept, Govt. College of Nursing, BMCH, Purba Bardhaman |
| Address |
Department of Psychiatric Nursing,
Room: Professor Room
Govt. College of Nursing, BMCH, Purba Bardhaman
Govt. College of Nursing, BMCH, Purba Bardhaman , Govt. of West Bengal
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9932653018 |
| Fax |
|
| Email |
barnooa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Barnali Mukherjee |
| Designation |
Professor |
| Affiliation |
Govt. College of Nursing, BMCH, Purba Bardhaman |
| Address |
Department of Psychiatric Nursing,
Room: Professor Room
Govt. College of Nursing, BMCH, Purba Bardhaman
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9932653018 |
| Fax |
|
| Email |
barnooa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Barnali Mukherjee |
| Designation |
Professor |
| Affiliation |
Govt. College of Nursing, BMCH, Purba Bardhaman |
| Address |
Department of Psychiatric Nursing,
Room: Professor Room
Govt. College of Nursing, BMCH, Purba Bardhaman
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9932653018 |
| Fax |
|
| Email |
barnooa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Psychiatry, Centre of Excellence, IPGME&R, SSKM Hospital, Kolkata, West Bengal, India
Pin: 700020 |
|
|
Primary Sponsor
|
| Name |
BARNALI MUKHERJEE |
| Address |
Institute of Psychiatry, Centre of Excellence, IPGME&R, SSKM Hospital, Kolkata, West Bengal, India
Pin: 700020 |
| Type of Sponsor |
Other [Self] |
|
|
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 Amit Bhattacharya Director Institute of Psychiatry COE IPGMER SSKM Hospital Kolkata |
Institute of Psychiatry, Centre of Excellence, IPGME&R, SSKM Hospital, Kolkata |
Institute of Psychiatry, Centre of Excellence, IPGME&R, SSKM Hospital, Kolkata, West Bengal, India
Pin: 700020
Kolkata
WEST BENGAL |
9830130143
amit.bhattacharya07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IPGME&R Research Oversight Commiittee, SSKM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Family members |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coping intervention program |
1. Three educational session on stress management, Coping strategies, self care of caregiver and problem solving method.
2. Two practice session on mindfulnessbased therapy and Progressive muscle relaxation therapy.
Coping intervention program:
Day-1 : pre test
On Day -1, day-3 and Day-5 educational sessions will be delivered.
From Day 7 onwards every alternate day practice session will be done on participants for 8 weeks.
Then post test will be taken at 8 weeks, after 15 days, One month and 3 month |
| Intervention |
Coping intervention program |
Educational session and practice session of coping, problem solving and mindfulness based therapy and Progressive muscle relaxation therapy |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Above 18 years and family members of diagnosed patients with schizophrenia or BPD, suffering from more than one year.
Family members who are givin direct care to patients |
|
| ExclusionCriteria |
| Details |
Family members who are mentally and physically ill |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing Caregiver burden |
at 8 weeks, after 1 month, after 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If the reduction of caregiver burden is persisting for long |
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
09/03/2026 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Back ground Mental health is the foundation for well-being and effective functioning of individuals which includes mental wellbeing, prevention of mental disorders, treatment and rehabilitation. WHO (2025) estimates that the burden of mental health problems in India is 2443 disability adjusted life years per 10000 population. 25 % global population suffering from mental illness. So the family members of mentally ill persons also suffers from burden of disease care.
Purpose: the purposes of the study are to reduce caregiver burden, improve coping and wellbeing of family members of mentally ill ill persons by providing coping intervention program. |