An Early Phase 1 interventional study of App based mindfulness program (ABMP) in Systemic Lupus Erythematosus and Inflammation, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of Wisconsin, Madison · Early Phase 1, Interventional, and Basic science
The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time.
Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects
Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.
1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
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Exclusion Criteria:
Control
Participants in this group will participate in App based mindfulness program (ABMP)
Behavioral: App based mindfulness program (ABMP)
App based mindfulness program (ABMP)
Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
Time frame: Baseline and 8 weeks
Change in phagocytic index of neutrophils
Neutrophil phagocytosis is measured by quantifying the ingestion of fluorescent zymosan or E.coli bioparticles using fluorescence microscopy. A phagocytic index is calculated to report the number of particles phagocytosed per cell.
Time frame: Baseline and 8 weeks
Change in neutrophil function as assessed by reactive oxygen species (ROS) production
Time frame: Baseline and 8 weeks
Change in neutrophils' migratory ability as assessed by change in neutrophils' velocity
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and velocity (μm/min) is measured.
Time frame: Baseline and 8 weeks
Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
Neutrophil migration is assessed using time lapse microscopy. The migration patterns of individual neutrophils are measured using NIH Image J FIJI and distance (μm) is quantified.
Time frame: Baseline and 8 weeks
Change in the expression of stress-induced genes
Time frame: Baseline and 8 weeks
Change in inflammatory cytokines level
Peripheral blood mononuclear cells (PBMC) and sub-populations including CD8 T cells and NK cells will be isolated from blood to study inflammatory cytokines level.
Time frame: Baseline and 8 weeks
Change in expression of 'immune cells activation markers'
Time frame: Baseline and 8 weeks
Change in the monocyte activation level
Monocytes will be analyzed by flow cytometry for activation markers and other markers of cell function.
Time frame: Baseline and 8 weeks
Change in the methylation pattern of stress-induced genes
Time frame: Baseline and 8 weeks
Change in the gene expression pattern of stress induced genes
Time frame: Baseline and 8 weeks
Change in the cytokine secretion level from immune cells
Time frame: Baseline and 8 weeks
Change in PROMIS-GH (Patient-Reported Outcomes Measurement Information System Global Health) score
PROMIS self-report measures are intended to be completed by the respondent without help from anyone else. The PROMIS GH is comprised of 10 global items. Each item represents a different domain of health. Mental health and physical health summary scores are computed and standardized to the general population. Both these component scores and individual global items can be used to assess patients' perceptions of their health. PROMIS global health can be converted to raw scores between 4-20 that can be converted to a t-score of 16.2-67.7. A higher score reflects better functioning.
Time frame: Baseline and 8 weeks
Change in State Trait Anxiety Inventory (STAI) Score
The State Trail Anxiety Inventory is a 20 item questionnaire about how the participant is feeling. The total possible range of scores is 20-80 lower scores indicate less anxiety.
Time frame: Baseline and 8 weeks
Change in Five Facet Mindfulness Questionnaire (FFMQ)
FFMQ is a 39-item questionnaire scored on a 5 pt likert scale for a total possible range of scores 39-195 where higher scores indicate increased mindfulness.
Time frame: Baseline and 8 weeks
Change in the Perceived Stress Scale
The Perceived Stress Scale is a 10-item survey scored on a 5-pt likert scale for a total possible range of scores 0-40 where higher scores indicate increased perceived stress.
Time frame: Baseline and 8 weeks
Change in PROMIS-Positive Affect Score
The PROMIS-Positive Affect Score is based on a 15-item survey, each item scored on a 5-pt likert scale for a total possible range of scores 15-75 where higher score indicated higher positivity.
Time frame: Baseline and 8 weeks
Change in PROMIS-Depression Score
The PROMIS-Depression Score is based on a 6-item survey, each item scored on a 5-pt likert scale for a total possible range of scores 6-30 where higher score indicate increased depression.
Time frame: Baseline and 8 weeks
Plan to share: No
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Lupus Erythematosus, Systemic →
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