Clinical trial NCT03930225: Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
Official title: Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Schizophrenia
Stigma, Social
Keywords: Stigma
Intervention program
Schizophrenia
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2019-04-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Eligibility 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- -

Primary outcomes:
measure: change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale
timeFrame: 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
measure: change in perceived family burden using the perceived family burden scale
timeFrame: 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
measure: change in medication adherence using customized chart for each patient
timeFrame: 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:
measure: change in the clinical outcome using Positive and Negative Symptoms Scale
timeFrame: 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
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Psychiatry Department
state: Dakahlya
Study officials:
affiliation: Pittsburgh university
name: Vishwaijt Nimgaonkar, PhD
role: STUDY_CHAIR
References: