SchizophreniaNCT03930225
Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
A study testing Stigma Directed Psycho-educational Intervention program in people with Schizophrenia and Stigma, Social, run by Mansoura University at 1 site in Egypt.
Trial summary
randomized controlled study measuring the effectiveness of Stigma focused intervention in patients suffering from Schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Stigma, Social
- What is being tested?
- Stigma Directed Psycho-educational Intervention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2019to 2 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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- -
Trial locations and contacts
1 site in 1 country.
About this study
randomized controlled study measuring the effectiveness of Stigma focused intervention in patients suffering from Schizophrenia
Read the 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
- 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
- Conditions
- Schizophrenia, Stigma, Social
- Being tested
- Stigma Directed Psycho-educational Intervention program
- Keywords
- Stigma, Intervention program, Schizophrenia
- Medical subject headings
- Schizophrenia, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma Directed Psycho-educational Intervention programBehavioural
psycho-educational intervention with emphasis on Stigma
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: 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. Receives: Behavioral: Stigma Directed Psycho-educational Intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Self-Stigma using the Arabic version of the internalized stigma of mental illness scale
stigma as experienced by patients themselves
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start16 Apr 2019
- Primary completion30 Jun 2024
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Noha Amer, Mansoura University
- Investigators
- Vishwaijt Nimgaonkar, PhD, Study chair, Pittsburgh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930225
- Sponsor's protocol ID
- MD/17.11.33
- Status last verified
- Jul 2025
- First submitted
- 24 Apr 2019
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of A Stigma Directed Interventional Program in Schizophrenia
- ClinicalTrials.gov ID
- NCT03930225
- Acronym / sponsor ID
- MD/17.11.33
- Conditions
- Schizophrenia, Stigma, Social
- Keywords
- Stigma, Intervention program, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: Stigma Directed Psycho-educational Intervention programIn 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" |
| control group | Other | Behavioral: Stigma Directed Psycho-educational Intervention programIn the control group, only Patients will attend the psycho-educational sessions. Family members and patients will be required to attend the assessment sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stigma Directed Psycho-educational Intervention programpsycho-educational intervention with emphasis on Stigma | Behavioural | control group, study group |
Primary outcome
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishwaijt Nimgaonkar, PhD study chair
Pittsburgh university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stigma Directed Psycho-educational Intervention program in people with Schizophrenia and Stigma, Social, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.