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ABOUT THIS STUDY
Linking a psychosocial stress intervention with clinical measures of stress in African
American lupus patients will assess the utility of this method in reducing perceived stress,
and provide the necessary preliminary steps toward future investigations of potential
mechanisms.
Study Location
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 18 years of age or older
- African American
- Diagnosis of Lupus
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Previous participation in a disease self management program
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Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Balancing Lupus Experiences With Stress Strategies | ||||||
| Official Title ICMJE | An Intervention to Reduce Psychosocial and Biological Indicators of Stress in African American Lupus Patients: The Balancing Lupus Experiences With Stress Strategies (BLESS) Study | ||||||
| Brief Summary | Linking a psychosocial stress intervention with clinical measures of stress in African American lupus patients will assess the utility of this method in reducing perceived stress, and provide the necessary preliminary steps toward future investigations of potential mechanisms. | ||||||
| Detailed Description | To begin to fill this research void, a stress intervention will be piloted and both biological specimens and questionnaire responses collected to assess changes in stress state following the intervention in patients who participated in the intervention compared to those who did not participate in the intervention. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 Phase 2 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single (Care Provider) Primary Purpose: Health Services Research | ||||||
| Condition ICMJE | Systemic Lupus Erythematosus | ||||||
| Intervention ICMJE | Behavioral: Arthritis Self Management Program
Intervention activities will consist of six weekly sessions of the Arthritis Self-Management Program (ASMP). Sessions will be administered in a group setting with the 15 African American lupus patients randomly assigned to the intervention arm of the study. Fifteen other patients will serve as controls and receive usual care. Patients participating in the stress intervention will receive six weeks of peer led sessions ranging in disease-specific and more general self-help content. The intervention will include homework assignments to practice and record use of session techniques and to complete worksheets regarding session-specific topics and activities. Usual care will include a brief explanation of the disease and relevant literature. | ||||||
| Study Arms ICMJE | Experimental: Self management program
The Arthritis Self-Management Program (ASMP) will be administered to 15 African American lupus patients participating in an ongoing "SLE Clinic Database Project" at the Medical University of South Carolina (MUSC). Fifteen other patients will serve as controls and receive usual care. Intervention: Behavioral: Arthritis Self Management Program | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Estimated Enrollment ICMJE | 30 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | October 2011 | ||||||
| Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01351662 | ||||||
| Other Study ID Numbers ICMJE | BLESS | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Edith Williams, University of South Carolina | ||||||
| Study Sponsor ICMJE | Medical University of South Carolina | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Medical University of South Carolina | ||||||
| Verification Date | April 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||