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Balancing Lupus Experiences With Stress Strategies

NCT ID: NCT01351662

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Systemic Lupus Erythematosus

Keywords

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Lupus stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Arthritis Self Management Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous participation in a disease self management program
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edith M Williams, PhD

Role: STUDY_DIRECTOR

University of South Carolina

James C Oates, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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BLESS

Identifier Type: -

Identifier Source: org_study_id