- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00699985
Psychological Symptoms in Patients With Behcet's Disease by SCL90-R (SCL90-R)
August 13, 2010 updated by: Tehran University of Medical Sciences
Comparison of Psychological Symptoms in Patients With Behcet's Disease and Control Patients by Symptom Check List 90-Revised (SCL-90-R)
To find the overall psychological profile of patients with Behcet's Disease (BD) and compare it with Non-BD patients.patients
were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R)
Study Overview
Status
Completed
Conditions
Detailed Description
200 BD and 200 Non-BD patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R).
BD diagnosis was based on the new International Criteria for Behcet's Disease (ICBD).
Non-BD patients were patients mimicking BD.
All patients were asked to complete the SCL90-R when they attended the clinic for their routine follow-up.
The demographic information and disease manifestations including ocular and neurological involvement were registered.
For those with visual impairment, SCL90-R was applied by an interviewer.
Frequencies and descriptive analysis were measured in both BD and Non-BD groups.
Means and standard deviations (SD) of visual acuity were calculated.
Data collected from SCL90-R did not have normal distribution in any dimension.
The mean values of raw numbers, global severity index (GSI), the positive symptoms total (PST) and the positive symptom distress index (PSDI), were compared by Mann-Whitney U (M-W U) test.).To detect any bias in results due to data collection method, self reported data and reviewer collected data were compared.
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of, 14114
- Rheumatology Research Center, Shariati Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
BD and Non-BD patients who attended the clinic for their routine follow-up.
Description
Inclusion Criteria:
- Behcet's disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD).
- Non-Behcet's disease patients were patients mimicking BD.
Exclusion Criteria:
- Probable Behcet's Disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Behcet's Disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD).
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2
Non-Behcet's Disease patients were patients mimicking BD.
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What is the study measuring?
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Total score of SCL90-R dimensions and global indexes
Time Frame: 22months
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22months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Bahar Sadeghi, MD, Rheumatology Research Center, Tehran University for Medical Sciences
- Principal Investigator: Maryam Noroozian, MD, Memory and Behavioral Department, Roozbeh Hospital, Tehran University for Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
June 17, 2008
First Submitted That Met QC Criteria
June 17, 2008
First Posted (ESTIMATE)
June 18, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
August 16, 2010
Last Update Submitted That Met QC Criteria
August 13, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 132/11872
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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