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Clinical Trials/CTRI/2017/02/007803
CTRI/2017/02/007803
Completed
Not Applicable

Effectiveness of Positive Family Interactions Module on the Expressed Emotion of the Caregivers and Relapse of Patients with Schizophrenia: A Prospective Study in a Selected Psychiatric Inpatient Facility

Agnes E J1 site in 1 country100 target enrollmentStarted: January 7, 2015Last updated:
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Overview

Phase
Not Applicable
Status
Completed
Sponsor
Agnes E J
Enrollment
100
Locations
1
Primary Endpoint
PANSS scores of patients
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The study approach is evaluative and use quasi experimental design. Sample size is 100, 50 each in the PFIM group and TAU group. The expressed emotion of caregivers are found to cause relapse among patients with schizophrenia. Family interventions are found to be helpful in reducing the expressed emotion, thereby reducing the relapse.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Not Applicable

Eligibility Criteria

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

Inclusion Criteria

  • •Patients with the diagnosis of schizophrenia as per ICD-
  • •Patients with the caregivers who are willing to come for six-months follow-up.
  • •Patients who had at least two hospitalizations and with a duration of at least 6 months of illness
  • •Caregivers who are residing with the patient for the last one year
  • •Patients and caregivers who can speak English,Malayalam or Kannada.

Exclusion Criteria

  • •Caregivers with physical disability
  • •Caregivers with a diagnosed psychiatric disorder
  • •Patients with co-morbid medical surgical illness and substance abuse.

Outcomes

Primary Outcomes

PANSS scores of patients

Time Frame: one, three and six months

Secondary Outcomes

  • Expressed emotion scores of family caregivers(one, three and six months)

Investigators

Sponsor
Agnes E J
Sponsor Class
Other []

Study Sites (1)

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