Psychological Symptoms in Patients With Behcet's Disease by SCL90-R

• Sponsor: Tehran University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00699985
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 26.7

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Behcet's Syndrome

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 Design

• Study Type: Observational
• Actual Enrollment: 400 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Comparison of Psychological Symptoms in Patients With Behcet's Disease and Control Patients by Symptom Check List 90-Revised (SCL-90-R)
• Study Start Date: Sep 1, 2006
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
1 Behcet's Disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD).
2 Non-Behcet's Disease patients were patients mimicking BD.

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

1. Total score of SCL90-R dimensions and global indexes [22months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheumatology Research Center, Shariati Hospital	Tehran		Iran, Islamic Republic of	14114

Sponsors and Collaborators

• Tehran University of Medical Sciences

Investigators

• Study Director: Bahar Sadeghi, MD, Rheumatology Research Center, Tehran University for Medical Sciences
• Principal Investigator: Fereydoun Davatchi, 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
• Principal Investigator: Farhad Shahram, MD, Rheumatology Research Center, Tehran University for Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00699985
• Other Study ID Numbers: 132/11872
• First Posted: Jun 18, 2008
• Last Update Posted: Aug 16, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Psychological Symptoms; Behcet's Disease
• Additional relevant MeSH terms: Behcet Syndrome

Study Results

No Results Posted as of Aug 16, 2010