Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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
Study 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
- Family burden on the caregiver (Family member).
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
the outcome will be assessed by a different personnel than the investigator conducting the sessions of the intervention. The outcomes assessor will be blinded to which arm each participant belongs.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Co morbid intellectual disability.
- •Co morbid chronic medical or neurological condition or history of serious head trauma.
- •Exclusion Criteria for family members:
- •Sever physical illness that hinders their participation- -
Arms & Interventions
study group
In the study group, both patients and their family members will be required to attend a weekly 1 hour long psycho-educational sessions. Moreover assessment sessions will be attended also.
"The stigma directed intervention program"
Intervention: Stigma Directed Psycho-educational Intervention program (Behavioral)
control group
In the control group, only Patients will attend the psycho-educational sessions.
Family members and patients will be required to attend the assessment sessions.
Intervention: Stigma Directed Psycho-educational Intervention program (Behavioral)
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)
Investigators
Noha Amer
Local Principal Investigator
Mansoura University