Systemic Lupus ErythematosusPhase 1/2BLESSNCT01351662
Balancing Lupus Experiences With Stress Strategies
A Phase 1/2 study testing Arthritis Self Management Program in people with Systemic Lupus Erythematosus, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Arthritis Self Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- African American
- Diagnosis of Lupus
Who cannot join
- Previous participation in a disease self management program
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Arthritis Self Management Program
- Keywords
- Lupus, stress
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthritis Self Management ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| Self management program | Experimental | 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. Receives: Behavioral: Arthritis Self Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress
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.
Measured: Four months
Biological Indicators of stress
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.
Measured: Four months
Secondary outcomes (1)
Quality of Life
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.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Edith M Williams, PhD, Study director, University of South CarolinaJames C Oates, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351662
- Sponsor's protocol ID
- BLESS
- Acronym
- BLESS
- Status last verified
- Dec 2025
- First submitted
- 9 May 2011
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01351662
- Acronym / sponsor ID
- BLESS / BLESS
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, stress
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self management program | Experimental | Behavioral: Arthritis Self Management ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- African American
- Diagnosis of Lupus
Key exclusion criteria (1 listed)
- Previous participation in a disease self management program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthritis Self Management ProgramIntervention 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. | Behavioural | Self management program |
Primary outcome
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.
1 secondary outcome
Quality of Life
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith M Williams, PhD study director
University of South Carolina
James C Oates, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arthritis Self Management Program in people with Systemic Lupus Erythematosus, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress (time frame: Four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.