Back to resultsEffectiveness of A Stigma Directed Interventional Program in Schizophrenia
Primary Purpose
Schizophrenia, Stigma, Social
Status
Suspended
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Stigma Directed Psycho-educational Intervention program
Sponsored by
About this trial
This is an interventional health services research trial for Schizophrenia focused on measuring Stigma, Intervention program, Schizophrenia
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.
- 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- -
Sites / Locations
- Mansoura University Psychiatry Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
study group
control group
Arm Description
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"
In the control group, only Patients will attend the psycho-educational sessions. Family members and patients will be required to attend the assessment sessions.
Outcomes
Primary Outcome Measures
change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale
stigma as experienced by patients themselves
change in perceived family burden using the perceived family burden scale
how much the disorder represent a burden on family
change in medication adherence using customized chart for each patient
the degree the patient adhere to the prescribed medications
Secondary Outcome Measures
change in the clinical outcome using Positive and Negative Symptoms Scale
Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. In addition to these measures, a Composite Scale is scored by subtracting the negative score from the positive score. This yields a bipolar index that ranges from -42 to +42, which is essentially a difference score reflecting the degree of predominance of one syndrome in relation to the other.
Full Information
NCT ID
NCT03930225
First Posted
April 24, 2019
Last Updated
August 31, 2021
Sponsor
Mansoura University
Collaborators
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03930225
Brief Title
Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
Official Title
Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Suspended
Why Stopped
Covid 19 Break has caused the research to stop temporarily for safety of participants and conductors
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
Collaborators
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Stigma, Social
Keywords
Stigma, Intervention program, Schizophrenia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
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.
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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"
Arm Title
control group
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Stigma Directed Psycho-educational Intervention program
Intervention Description
psycho-educational intervention with emphasis on Stigma
Primary Outcome Measure Information:
Title
change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale
Description
stigma as experienced by patients themselves
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
Title
change in perceived family burden using the perceived family burden scale
Description
how much the disorder represent a burden on family
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
Title
change in medication adherence using customized chart for each patient
Description
the degree the patient adhere to the prescribed medications
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
Secondary Outcome Measure Information:
Title
change in the clinical outcome using Positive and Negative Symptoms Scale
Description
Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. In addition to these measures, a Composite Scale is scored by subtracting the negative score from the positive score. This yields a bipolar index that ranges from -42 to +42, which is essentially a difference score reflecting the degree of predominance of one syndrome in relation to the other.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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- -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishwaijt Nimgaonkar, PhD
Organizational Affiliation
Pittsburgh university
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Psychiatry Department
City
Mansoura
State/Province
Dakahlya
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
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