View Clinical Trial (Medical Research Study)
Reducing Depressive Symptoms in Systemic Lupus Erythematosus
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15232 |
| Conditions: |
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Systemic Lupus Erythematosus |
| Purpose: |
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The purpose of this randomized controlled trial is to evaluate the efficacy of a Mind-Body
Skills Training intervention for improving mental and physical health in patients with
Systemic Lupus Erythematosus (SLE) who have comorbid depressive symptoms.
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| Study Summary: |
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Systemic lupus erythematosus (SLE) is a chronic, multisystemic inflammatory disease that is
frequently associated with significant psychological suffering. Building upon our team's
strengths in lupus biomedical research and behavioral interventions, we propose to study a
non-pharmacologic intervention to improve mental and physical health of patients with SLE
and co-morbid depression.
In this project, entitled, Reducing Depressive Symptoms in SLE, we will investigate the
efficacy of an innovative non-pharmacologic intervention, Mind-Body Skills Training (MBST)
for improving mental and physical health outcomes in SLE in a randomized controlled trial
(RCT). MBST is a novel approach that combines cognitive-behavioral therapy methods,
mind-body relaxation skills, and mindfulness components, each of which is beneficial for
reducing pain and/or distress in other inflammatory conditions. We will assign 150 SLE
patients with depressive disorder or subsyndromal depression to MBST or to a supportive
counseling control condition. The primary specific aims of the project are to evaluate the
effects of the 8-session MBST program on 1) mental health (depression) and 2) physical
health (pain, fatigue, and health-related quality of life). Additionally we will explore
the effects of the MBST intervention on 1) novel SLE biomarkers of inflammation and immune
function: cell-bound complement activation products, developed at our site, 2) measures of
SLE disease activity, and we will explore 3) potential treatment modifiers and mediators:
baseline pain and socioeconomic status, and self-efficacy and perceived stress. We will
evaluate health outcomes after the interventions and at 6- and 12-months follow-up.
SLE is one of the most complex autoimmune diseases, with one of the highest rates of
depression. The MBST intervention has strong potential for addressing the unique physical
manifestations and mental suffering in this patient group, and may have broad impact on
distressed patients with other debilitating chronic diseases.
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| Criteria: |
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Inclusion Criteria:
- Diagnosis of SLE according to 1997 updated SLE criteria (Hochberg 1997)
- Women and men of all races/ethnic groups age 18 and over
- Able to speak and read English
- Willing to be randomized to either MBST or SC and attend sessions
- Medications stable for at least one month
- Dose of prednisone or equivalent < 15 mg per day
- PHQ-9 score > or = 9
- BILAG classification B, C, D, or E: indicating a level of SLE activity not requiring
new or increased medication
- CES-D score > or = 16
- QIDS-C endorsement of subsyndromal or greater depression symptoms
- Not currently seeking psychiatric disability benefits
Exclusion Criteria:
- BILAG A, indicating new SLE flare requiring an immediate dose adjustment or addition
of corticosteroid or immunosuppressant treatment.
- Uncontrolled medical condition (e.g., severe infection) that is determined by the
research physicians to put the participant at undue risk or to interfere with ability
to participate in the study.
- Psychosis, bipolar disorder, actively suicidal or otherwise requiring immediate
psychiatric treatment, as determined by diagnostic interview (SCID).
- Current skills-based psychotherapy. However, if patients are currently receiving
supportive psychotherapy and are willing to suspend this for the duration of the
intervention period, they may enroll in the study.
- Pregnancy.
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| NCT ID: |
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NCT01120652 |
| Primary Contact: |
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Principal Investigator
Carol M. Greco, Ph.D.
University of Pittsburgh
Megan DeBertrand, BA
Phone: 412-623-2374
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| Backup Contact: |
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Adam White, BS
Phone: 412-623-2374
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| Location Contact: |
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Pittsburgh, Pennsylvania 15232
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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