Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

Not Applicable

Suspended

• Conditions: Schizophrenia; Stigma, Social
• Interventions: Behavioral: Stigma Directed Psycho-educational Intervention program

• Registration Number: NCT03930225
• Lead Sponsor: Mansoura University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 160

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- -

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Stigma Directed Psycho-educational 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.
study group	Stigma Directed Psycho-educational Intervention program	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"

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mansoura University Psychiatry Department; 🇪🇬 Mansoura, Dakahlya, Egypt