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Balancing Lupus Experiences With Stress Strategies (BLESS)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Edith Williams, University of South Carolina
ClinicalTrials.gov Identifier:
NCT01351662
First received: May 9, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Behavioral: Arthritis Self Management Program
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: An Intervention to Reduce Psychosocial and Biological Indicators of Stress in African American Lupus Patients: The Balancing Lupus Experiences With Stress Strategies (BLESS) Study

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Perceived stress [ Time Frame: Four months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Four months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous participation in a disease self management program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351662

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Pfizer
Investigators
Study Director: Edith M Williams, PhD University of South Carolina
Principal Investigator: James C Oates, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Edith Williams, Research Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT01351662     History of Changes
Other Study ID Numbers: BLESS
Study First Received: May 9, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Lupus
stress

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2014