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Clinical Trials/NCT03930225
NCT03930225
Completed
Not Applicable

Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

Mansoura University1 site in 1 country80 target enrollmentApril 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Mansoura University
Enrollment
80
Locations
1
Primary Endpoint
change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

randomized controlled study measuring the effectiveness of Stigma focused intervention in patients suffering from Schizophrenia

Detailed Description

Effectiveness of A Stigma Directed Intervention Program in Schizophrenia It is a Randomized Controlled trial that aims at: * Assessment of the relationship between self- stigma and 1. Family burden on the caregiver (Family member). 2. Medication adherence by patients. * Assessment of the effectiveness of the family incorporation in the process of psychoeducation delivered to the patients suffering from Schizophrenia on the self-stigma and family burden of patients with Schizophrenia patients. The study will be held in Mansoura University hospital Psychiatry department and will include 80 Egyptian patients with Schizophrenia or Schizoaffective disorder will be recruited from Psychiatry department of Mansoura University Hospital

Registry
clinicaltrials.gov
Start Date
April 16, 2019
End Date
November 2, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha Amer

Local Principal Investigator

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • Patients meet the diagnosis of schizophrenia or schizoaffective disorder according to DSM5.The clinical condition is stabilized.
  • Age range between 18 to 50 years.
  • Male and female sexes are included.
  • Availability of close relative in direct contact with the patient.
  • Inclusion Criteria for the family members:
  • Primary caregiver and the family member share household with patient.
  • No history of receiving treatment of psychiatric disorders.
  • No history of serious head trauma.
  • Exclusion Criteria :
  • Co morbid substance abuse or dependence disorder.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale

Time Frame: Baseline assessment followed by Point 1 Assessment at the end of the 8 weekly sessions of the program ( after 2 months from baseline assessment) Final assessment after 3 months from point 1 Assessment

stigma as experienced by patients themselves

change in perceived family burden using the perceived family burden scale

Time Frame: Baseline assessment---- followed by Point 1 Assessment at the end of the 8 weekly sessions of the program ( after 2 months from baseline assessment) Final assessment after 3 months from point 1 Assessment

how much the disorder represent a burden on family

change in medication adherence using customized chart for each patient

Time Frame: Baseline assessment followed by Point 1 Assessment at the end of the 8 weekly sessions of the program ( after 2 months from baseline assessment) fFinal assessment after 3 months from point 1 Assessment

the degree the patient adhere to the prescribed medications

Secondary Outcomes

  • change in the clinical outcome using Positive and Negative Symptoms Scale(Baseline assessment followed by Point 1 Assessment at the end of the 8 weekly sessions of the program ( after 2 months from baseline assessment) Final assessment after 3 months from point 1 Assessment)

Study Sites (1)

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