Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

NCT03930225 | Completed

• 1 other identifier: MD/17.11.33
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Stigma, Social

Keywords

Stigma; Intervention program; Schizophrenia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Study Arms (2)

study group

EXPERIMENTAL

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

control group

OTHER

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

Interventions

Stigma Directed Psycho-educational Intervention program BEHAVIORAL

psycho-educational intervention with emphasis on Stigma

control group; study group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients meet the diagnosis of schizophrenia or schizoaffective disorder according to DSM5.The clinical condition is stabilized.
• Age range between 18 to 50 years.
• Male and female sexes are included.
• Availability of close relative in direct contact with the patient.
• Primary caregiver and the family member share household with patient.
• No history of receiving treatment of psychiatric disorders.
• No history of serious head trauma.

You may not qualify if:

• Co morbid substance abuse or dependence disorder.
• Co morbid intellectual disability.
• Co morbid chronic medical or neurological condition or history of serious head trauma.
• Sever physical illness that hinders their participation- -

Sponsors & Collaborators

• Mansoura University: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Mansoura University Psychiatry Department

Al Mansurah, Dakahlya, Egypt

Location

MeSH Terms

Conditions

Schizophrenia; Social Stigma

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Vishwaijt Nimgaonkar, PhD

  Pittsburgh university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Local Principal Investigator

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: April 16, 2019
• Primary Completion: June 30, 2024
• Study Completion: November 2, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)