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Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

  • Clinicaltrials.gov identifier

    NCT03930225

  • Recruitment Status

    Suspended (Covid 19 Break has caused the research to stop temporarily for safety of participants and conductors)

  • First Posted

    April 29, 2019

  • Last update posted

    July 23, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Stigma, Social
    Schizophrenia
  • Intervention/Treatment: Behavioral: Stigma Directed Psycho-educational Intervention program
  • Phase: N/A

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

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 160 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Randomized Controlled Study
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Health Services Research
  • Official Title: Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: May 2021

Arms and interventions

Arm Intervention/treatment
Other: 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
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

Outcome Measures

  • 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 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- -

Contacts and Locations

Contacts

Locations

Egypt, Dakahlya
Mansoura University Psychiatry Department
Mansoura

Sponsors and Collaborators

Mansoura University

University of Pittsburgh

Investigators

Study Chair: Vishwaijt Nimgaonkar, PhD Pittsburgh university

More Information

  • Responsible Party: Mansoura University
  • ClinicalTrials.gov Identifier: NCT03930225 History of Changes
  • Other Study ID Numbers: MD/17.11.33
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: July 23, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Mansoura University: Stigma
    Intervention program
    Schizophrenia
  • Additional relevant MeSH terms: Schizophrenia