- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01120652
Reducing Depressive Symptoms in Systemic Lupus Erythematosus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mind-Body Skills Training
This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices.
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This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices.
MBST is provided in 8 individual sessions, each lasting approximately one hour.
Ideally, sessions take place on a weekly basis, so that the intervention phase of the study lasts for approximately two months.
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Active Comparator: Supportive Counseling
This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice.
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This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice.
SC is provided in 8 individual sessions, each lasting approximately one hour.
Ideally, sessions take place on a weekly basis, so that the intervention phase of the study lasts for approximately two months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center for Epidemiologic Studies Depression scale (CESD)
Time Frame: approximately 1 year following the 8 session intervention
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The CESD is a self report questionnaire designed to assess depressive symptoms.
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approximately 1 year following the 8 session intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain (Multidimensional Pain Inventory - Pain Severity scale)
Time Frame: approximately 1 year following the 8 session intervention
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The MPI Pain Severity scale is a 3 item self report instrument to assess current and past week pain severity
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approximately 1 year following the 8 session intervention
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Fatigue (PROMIS - fatigue scale - short form)
Time Frame: approximately 1 year following the 8 session intervention
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The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form scale assesses past week fatigue.
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approximately 1 year following the 8 session intervention
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Health-related quality of life (SF-12 health survey)
Time Frame: approximately 1 year following the 8 session intervention
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approximately 1 year following the 8 session intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carol M. Greco, Ph.D., University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AR057338
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Mind-Body Skills Training (MBST)
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The Center for Mind-Body MedicineSilicon Valley Community FoundationCompleted
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University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
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The Center for Mind-Body MedicineThe Atlantic PhilanthropiesCompletedPosttraumatic Stress DisorderIsrael
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The Center for Mind-Body MedicineThe Atlantic PhilanthropiesCompletedPosttraumatic Stress DisorderIsrael
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The Center for Mind-Body MedicineHerbert Simon Family FoundationEnrolling by invitation
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The Center for Mind-Body MedicineCompletedAggression | Problem Behavior | Posttraumatic Stress DisorderPalestinian Territory, occupied
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The Center for Mind-Body MedicineCompletedStress Disorders, Post-traumaticFormer Yugoslavia