| CTRI Number |
CTRI/2025/11/098056 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psychoeducational intervention on expressed emotion burden of care and quality of life] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Educational programme to help family members of patients with mind related problems to feel less stressed and live better life |
|
Scientific Title of Study
|
Effectiveness of psychoeducational intervention on the expressed emotion burden of care and quality of life among caregivers of mentally ill patients in mental health centres |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aayushi Mahat |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
PhD Section Ground floor Teerthanker Mahaveer College of Nursing PhD Cell Teerthanker Mahaveer University National Highway 24 Delhi Road Bagarpur Moradabaad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7908874408 |
| Fax |
|
| Email |
aayushi.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar |
| Designation |
Professor and Coordinator |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Room No 109 Teerthanker Mahaveer College of Nursing PhD Cell Teerthanker Mahaveer University National Highway 24 Delhi Road Bagarpur Moradabaad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9813893463 |
| Fax |
|
| Email |
dryogesh.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmal Kumar Bera |
| Designation |
Head of Department Psychiatric Department |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Room No 32 Psychiatric OPD North Bengal Medical College and Hospital Sushruta Nagar PO Sushrutanagar Siliguri
Darjiling
WEST BENGAL
734012
India |
| Phone |
9434006972 |
| Fax |
|
| Email |
drbera@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| North Bengal Medical College and Hospital Sushruta Nagar Siliguri District Darjeeling West Bengal India Pin Code 734012 |
|
|
Primary Sponsor
|
| Name |
Aayushi Mahat |
| Address |
Teerthanker Mahaveer College of Nursing PhD Cell Teerthanker Mahaveer University National Highway 24 Delhi Road Bagadpur Moradabaad Uttar Pradesh Pin Code 244001 |
| 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 Nirmal Kumar Bera |
North Bengal Medical College and Hospital |
Room No 32 Psychiatric OPD Sushrutanagar District Darjeeling West Bengal Pin Code 734012
Darjiling
WEST BENGAL |
9434006972
drbera@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government of West Bengal North Bengal Medical College Darjeeling Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Family Caregivers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Psychoeducational Intervention |
Psychoeducational Intervention include educational sessions emotional support stress management clarification of doubts and ways of coping strategies The total duration will be 1.5 years |
| Comparator Agent |
Routine Support |
Caregiver of the mentally ill patient will receive the usual informal support provided as a part of standard care The total duration will be 1.5 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers caring for mentally ill patient for a period of more than six months
Caregivers caring for mentally ill patient who are having psychotic symptoms for a period of minimum six months
Caregivers aged between 18 to 60 years
Caregivers who can understand English or Bengali or Nepali or Hindi language
Caregivers of mentally ill patients attending mental health centre in the Northern West Bengal
Caregivers who are willing to participate in the study
Caregivers who are available during data collection |
|
| ExclusionCriteria |
| Details |
Caregivers caring for mentally ill patient for a period of less than six months
Caregivers caring for mentally ill patient who are having psychotic symptoms for less than six months
Caregivers aged less than 18 years and more than 60 years
Caregivers who cannot understand English or Bengali or Nepali or Hindi language
Caregivers of mentally ill patients not attending mental health centre in the Northern West Bengal
Caregivers who are not willing to participate in the study
Caregivers who are not available during data collection |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in caregivers expressed emotion burden of care and improvement on their quality of life |
20 months |
|
|
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)
|
08/12/2025 |
| 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="8"
Days="16" |
|
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
|
Mental health problems account for 35 point 6 percentage of the overall burden of illness and rank second among the leading causes of disability worldwide In West Bengal over 1 point 25 crore people suffer from various mental health issues affecting not only patients but also their caregivers who face emotional distress high care burden and reduced quality of life In India family members are the primary caregivers making them highly vulnerable to stress and burnout Research highlights that caregivers of patients with schizophrenia often exhibit high expressed emotion linked to increased relapse rates and prolonged illness with greater emotional expression among female caregivers and those providing long term care Caregiver burden is significant particularly for those with lower education financial strain and extended caregiving hours while quality of life is often compromised influenced by age relationship to the patient and social support Psycho-educational interventions consisting of structured sessions on illness education coping strategies communication and stress management have been shown to reduce expressed emotion alleviate caregiver burden and improve quality of life across diverse contexts This study using a quantitative true experimental design with 100 caregivers randomly assigned to experimental and control group in Northern West Bengal aims to evaluate the effectiveness of such interventions assess relationships between expressed emotion burden of care and quality of life and examine associations with socio demographic variables Outcomes will be measured by using Brief Psychiatric Rating Scale Family Emotional Involvement and Criticism Scale Zarit Burden Interview and WHO Quality of Life BREF Scale with data collected at baseline two months four months six months and analyzed using t test ANOVA correlations and chi square The research is expected to highlight caregivers unmet needs support the integration of caregiver focused strategies into mental healthcare inform policy and guide the design of future culturally tailored interventions |