Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

NCT ID: NCT03930225

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2024-11-02

Brief Summary

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

Detailed Description

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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

Conditions

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Schizophrenia Stigma, Social

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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"

Group Type EXPERIMENTAL

Stigma Directed Psycho-educational Intervention program

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Stigma Directed Psycho-educational Intervention program

Intervention Type BEHAVIORAL

psycho-educational intervention with emphasis on Stigma

Interventions

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Stigma Directed Psycho-educational Intervention program

psycho-educational intervention with emphasis on Stigma

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


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.


-Sever physical illness that hinders their participation- -
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Noha Amer

Local Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vishwaijt Nimgaonkar, PhD

Role: STUDY_CHAIR

Pittsburgh university

Locations

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Mansoura University Psychiatry Department

Al Mansurah, Dakahlya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD/17.11.33

Identifier Type: -

Identifier Source: org_study_id

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