Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

Study Overview
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Brief Summary
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randomized controlled study measuring the effectiveness of Stigma focused intervention in patients suffering from Schizophrenia

Detailed Description
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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

Official Title
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Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

Conditions
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Schizophrenia, Stigma, Social

Intervention / Treatment
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* Behavioral: Stigma Directed Psycho-educational Intervention program


Participation Criteria
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Eligibility Criteria
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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- -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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 | Behavioral: Stigma Directed Psycho-educational Intervention program<br>* psycho-educational intervention with emphasis on Stigma<br>|
| Other: control group<br>In the control group, only Patients will attend the psycho-educational sessions. Family members and patients will be required to attend the assessment sessions. | Behavioral: Stigma Directed Psycho-educational Intervention program<br>* psycho-educational intervention with emphasis on Stigma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale | stigma as experienced by patients themselves | 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 | 
| change in perceived family burden using the perceived family burden scale | how much the disorder represent a burden on family | 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 | 
| change in medication adherence using customized chart for each patient | the degree the patient adhere to the prescribed medications | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stigma, Intervention program, Schizophrenia