Reducing Depressive Symptoms in Systemic Lupus Erythematosus
Completed · Not applicable
Conditions studied: Systemic Lupus Erythematosus
In brief
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.
Key facts
- Study ID
- NCT01120652
- Run by
- University of Pittsburgh
- People needed
- 90
- Starts
- 2009-11-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2015-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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