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Trial record 1 of 1 for:    NCT01351662
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Balancing Lupus Experiences With Stress Strategies (BLESS)

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ClinicalTrials.gov Identifier: NCT01351662
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : April 22, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Edith Williams, University of South Carolina

Tracking Information
First Submitted Date  ICMJE May 9, 2011
First Posted Date  ICMJE May 11, 2011
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • Perceived stress [ Time Frame: Four months ]
    Psychosocial stress will be assessed by five validated measures. The State-Trait Anxiety Inventory (STAI), The Perceptions of Racism Scale, modified version of the Medical Outcomes Study (MOS) health distress scale, adapted by the Stanford Patient Education Research Center, and The Beck Depression Inventory.
  • Biological Indicators of stress [ Time Frame: Four months ]
    Salivary specimens will be collected immediately preceding intervention activities, immediately following intervention activities, and four months post-intervention activities for analyses of salivary cortisol and Dehydroepiandrosterone (DHEA). Specified markers were chosen because they are easy to collect, relatively inexpensive, and reliable measures of stress.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
Quality of Life [ Time Frame: Four months ]
Quality of life will be assessed using two instruments that describe a spectrum of quality of life outcomes; The LUP-QOL and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Stanford Patient Education Research Center Questionnaires assessing medical outcomes will also be used. These scales also assess whether key behaviors concerning communicating with health care providers and health care utilization have changed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: May 10, 2011)
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:

  • 18 years of age or older
  • African American
  • Diagnosis of Lupus

Exclusion Criteria:

  • Previous participation in a disease self management program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Edith M Williams, PhD University of South Carolina
Principal Investigator: James C Oates, MD Medical University of South Carolina
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