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Clinical Trials/CTRI/2025/11/098056
CTRI/2025/11/098056Not yet recruitingNot Applicable

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

Aayushi Mahat1 site in 1 country100 target enrollmentStarted: December 8, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Significant reduction in caregivers expressed emotion burden of care and improvement on their quality of life

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Significant reduction in caregivers expressed emotion burden of care and improvement on their quality of life

Time Frame: 20 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aayushi Mahat
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Aayushi Mahat

Teerthanker Mahaveer University

Study Sites (1)

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