Balancing Lupus Experiences With Stress Strategies

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Behavioral: Arthritis Self Management Program

• Registration Number: NCT01351662
• Lead Sponsor: Medical University of South Carolina

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Previous participation in a disease self management program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self management program	Arthritis 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.

Primary Outcome Measures

Name	Time	Method
Perceived stress	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	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States