Schizophrenia, Stigma, Social
Conditions
Keywords
Stigma, Intervention program, Schizophrenia
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
Interventions
BEHAVIORALStigma Directed Psycho-educational Intervention program
psycho-educational intervention with emphasis on Stigma
Sponsors
University of Pittsburgh
Mansoura University
Study design
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.
Intervention model description
Randomized Controlled Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients meet the diagnosis of schizophrenia or schizoaffective disorder according to DSM5.The clinical condition is stabilized. 2. Age range between 18 to 50 years. 3. Male and female sexes are included. 4. Availability of close relative in direct contact with the patient. Inclusion Criteria for the family members: 1. Primary caregiver and the family member share household with patient. 2. No history of receiving treatment of psychiatric disorders. 3. No history of serious head trauma.
Exclusion criteria
: 1. Co morbid substance abuse or dependence disorder. 2. Co morbid intellectual disability. 3. Co morbid chronic medical or neurological condition or history of serious head trauma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Self-Stigma using the Arabic version of the internalized stigma of mental illness 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 | stigma as experienced by patients themselves |
| change in perceived family burden using the perceived family burden 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 | how much the disorder represent a burden on family |
| change in medication adherence using customized chart for each patient | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Egypt
Outcome results
None listed