Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

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

Study Overview

• Status: Suspended
• Conditions: Schizophrenia; Stigma, Social
• Intervention / Treatment: Behavioral: Stigma Directed Psycho-educational Intervention program

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlya
    • Mansoura, Dakahlya, Egypt
      • Mansoura University Psychiatry Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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- -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: University of Pittsburgh
• Investigators: Study Chair: Vishwaijt Nimgaonkar, PhD, Pittsburgh University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 16, 2019
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (ACTUAL): April 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Schizophrenia; Stigma; Intervention program
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: MD/17.11.33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No