Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03930225
• Other study ID #: MD/17.11.33
• Status: Suspended
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 160
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Exclusion Criteria for family members:

-Sever physical illness that hinders their participation- -

Related Conditions & MeSH terms

• Schizophrenia
• Stigma, Social

Intervention

Behavioral:
• Stigma Directed Psycho-educational Intervention program
psycho-educational intervention with emphasis on Stigma

Locations

Country	Name	City	State
Egypt	Mansoura University Psychiatry Department	Mansoura	Dakahlya

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	University of Pittsburgh

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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