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Completed

NCT Number: NCT03930225

Effectiveness of A Stigma Directed Interventional Program in Schizophrenia

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

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Key information

Conditions

Schizophrenia Behavior Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Social Behavior Social Stigma Stigma, Social

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Psychiatry Department

Al Mansurah, Dakahlya, Egypt

About this study

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
  • Family burden on the caregiver (Family member).
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Inclusion criteria

for the family members:

  • Primary caregiver and the family member share household with patient.
  • No history of receiving treatment of psychiatric disorders.
  • No history of serious head trauma.

Exclusion criteria

  • Co morbid substance abuse or dependence disorder.
  • Co morbid intellectual disability.
  • 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- -

Treatment and study plan

Stigma Directed Psycho-educational Intervention program

Behavioral

psycho-educational intervention with emphasis on Stigma

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

  • University of Pittsburgh

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2019
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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