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Behavioral Intervention
Mindfulness Program for Lupus
Phase < 1
Recruiting
Led By David Beebe, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI under 35
Lupus diagnosis according to >4 ACR 1987 criteria or >4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks
Awards & highlights
Study Summary
This trial is investigating the effects of stress and glucose intake on the immune system at the molecular level, including gene expression and protein analysis of immune cells in real time.
Who is the study for?
This trial is for individuals with lupus who can use a smartphone app daily, understand English, and have a BMI under 35. They must be diagnosed with lupus by specific criteria or a rheumatologist. Smokers, those currently ill or infected, practicing other mind-body techniques daily, pregnant or recently post-partum women, and people on certain medications are excluded.Check my eligibility
What is being tested?
The study tests an App Based Mindfulness Program (ABMP) to see if meditation affects neutrophil function and inflammation in lupus patients. It will examine changes in immune cells like monocytes and CD8 T cells after participants use the mindfulness app.See study design
What are the potential side effects?
Since this trial involves a mindfulness program delivered through an app rather than medication, traditional side effects are not expected. However, participants may experience increased relaxation or stress reduction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is below 35.
Select...
I have been diagnosed with lupus by a specialist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in neutrophil function as assessed by Neutrophil extracellular trap(NET) formation
Change in neutrophil function as assessed by reactive oxygen species (ROS) production
Change in neutrophils' migratory ability as assessed by change in "distance travelled" by neutrophils
+3 moreSecondary outcome measures
Change in expression of 'immune cells activation markers'
Change in inflammatory cytokines level
Change in the cytokine secretion level from immune cells
+3 moreOther outcome measures
Change in Five Facet Mindfulness Questionnaire (FFMQ)
Change in PROMIS-Depression Score
Change in PROMIS-GH (Patient-Reported Outcomes Measurement Information System Global Health) score
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: App based mindfulness program (ABMP)Experimental Treatment1 Intervention
Participants in this group will participate in App based mindfulness program (ABMP)
Group II: controlActive Control1 Intervention
Control
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,347 Total Patients Enrolled
1 Trials studying Lupus
200 Patients Enrolled for Lupus
David Beebe, PhDPrincipal InvestigatorUW Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Other factors that the doctor thinks are important for your safety and well-being.I have been diagnosed with lupus by a specialist.I have a history of serious health conditions like heart disease or diabetes.You have been diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, epilepsy, or seizures in the past.My BMI is below 35.I am taking medication that affects my mood or how my brain works.You regularly use other methods to improve your mental and physical health.If you practice yoga or tai chi every day, you cannot participate.I have completed a Mindfulness Based Stress Reduction program before.You use nicotine-containing products.I do not have any current severe illnesses or serious infections.I have significant experience in practicing meditation.Your current meditation practices will be evaluated by the principal investigator to decide if you are eligible for the trial. Different forms of meditation will be considered. For example, if you attend religious services or practice mindfulness, the decision will be based on how often and for how long you have been doing it.I am currently experiencing or being treated for a depressive episode.
Research Study Groups:
This trial has the following groups:- Group 1: control
- Group 2: App based mindfulness program (ABMP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being enrolled in this clinical trial?
"Indeed, the clinicaltrials.gov portal confirms that this medical research program is still searching for participants. This trial was initially listed on February 2nd 2022 and has been recently modified on April 11th 2021; 40 individuals are needed at one particular site."
Answered by AI
Is enrollment for this trial currently available to those seeking treatment?
"This medical trial, which was originally uploaded to clinicaltrials.gov on 2/2/2022, is recruiting participants as of 4/11/2022."
Answered by AI
For whom is this clinical trial appropriate?
"For this medical experiment, 40 individuals who suffer from inflammation and are between 21-65 years of age qualify. To be eligible, patients must have either Lupus diagnosis according to >4 ACR 1987 criteria or >4 SLICC 2012 criteria or a diagnosis confirmed by an accredited rheumatologist; BMI should not exceed 35; as well as access to an iOS/Android smartphone for daily app usage."
Answered by AI
Is the eligibility for this medical study limited to individuals younger than thirty years old?
"Per this research project's admission requirements, the lower limit for participation is 21 years old and upper age cap is 65."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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