An interventional study of Mindfulness Based Group Sessions in Lupus Erythematosus, Systemic, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
The study tests whether contemplative-based intervention can modify pathogenic processes in participants with Lupus. Techniques such as meditation, mindfulness and yoga may have an impact on the disease and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Additionally, incorporating patients' caregivers may strengthen their relationships and, thereby, improve their health and well-being.
The objective of this pilot study is to test the feasibility of an innovative contemplative-based and caregiver-inclusive intervention can modify pathogenic processes in systemic lupus erythematosus (SLE). Contemplative techniques such as meditation, mindfulness and yoga may have an impact on the disease burden and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Research also suggests that contemplative practices, such as an intensive mindfulness intervention, may have a direct effect on the underlying disease process itself by altering epigenetic control of gene expression, decreasing proinflammatory cytokine production and reestablishing immunologic homeostasis. It is also well documented that social relationships moderate physical health. Incorporating patients' caregivers may strengthen their relationships and thereby improve their health and well-being. It is anticipated that the successful outcome of the intervention described in this proposal will provide the basis for a new and effective contemplative-based and caregiver-inclusive therapy for SLE and other rheumatic diseases.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a single arm trial. All participants will be administered two baseline fMRIs and blood analysis prior to participation in a mindfulness group and individual mindfulness intervention sessions. A post intervention fMRI and blood analysis will complete the trial participation.
Behavioral: Mindfulness Based Group Sessions
In-person group intervention sessions conducted with a combination of meditation, group exercise (yoga), group discussions, deep breathing and other mindfulness based practices.
Change from baseline in blood
Number of participants with abnormal lab values (Complete Blood Count, Chemistry Panel, Autoantibodies, Complement C3 \& C4, Cytokines)
Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Change from baseline in brain activity during functional MRI
Number of participants with change in brain activity during functional MRI tasks (Handholding, Balloon Analog Risk Task, Penn Emotion Recognition Task, Operation Span Task, Resting State Task)
Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Change from baseline in Patient Reported Outcomes
Patient-reported change in health and symptoms
Time frame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
Change from baseline in SLE disease activity
Systemic Lupus Activity Questionnaire (SLAQ)
Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention
Change from baseline in psychosocial function
Self reported psychosocial function
Time frame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention
Change from baseline in Heart Rate Variability
Collected using emWave device
Time frame: Throughout the entire 6-week intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
University of Virginia