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Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03930225
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Noha Amer, Mansoura University

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

Condition or disease Intervention/treatment Phase
Schizophrenia Stigma, Social Behavioral: Stigma Directed Psycho-educational Intervention program Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Study
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.
Primary Purpose: Health Services Research
Official Title: Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: study group

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
psycho-educational intervention with emphasis on Stigma

control group

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
psycho-educational intervention with emphasis on Stigma




Primary Outcome Measures :
  1. change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale [ 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 ]
    stigma as experienced by patients themselves

  2. change in perceived family burden using the perceived family burden scale [ 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 ]
    how much the disorder represent a burden on family

  3. change in medication adherence using customized chart for each patient [ 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 ]
    the degree the patient adhere to the prescribed medications


Secondary Outcome Measures :
  1. change in the clinical outcome using Positive and Negative Symptoms Scale [ 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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- -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930225


Contacts
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Contact: Noha A Amer, MD 01002025960 noha.amer87@gmail.com

Locations
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Egypt
Mansoura University Psychiatry Department Recruiting
Mansoura, Dakahlya, Egypt
Contact: Noha A Amer, MD    01002025960    noha.amer87@gmail.com   
Sponsors and Collaborators
Mansoura University
University of Pittsburgh
Investigators
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Study Chair: Vishwaijt Nimgaonkar, PhD Pittsburgh university
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Responsible Party: Noha Amer, Local Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03930225    
Other Study ID Numbers: MD/17.11.33
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noha Amer, Mansoura University:
Stigma
Intervention program
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders