Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT04857151
Eligibility Criteria:
Inclusion Criteria:
* Lupus diagnosis according to \>4 ACR 1987 criteria or \>4 SLICC 2012 criteria or a diagnosis confirmed by a board-certified rheumatologist
* Capacity to provide informed consent and ability to speak and read English
* BMI under 35
* Must have access to an iOS or android smartphone to allow daily use of an app
Exclusion Criteria:
* Currently participating in another clinical trial with intervention. Participation in observational clinical trials is not grounds for exclusion.
* History of significant systemic disease (eg. cancer, infection, hematological, renal, hepatic, coronary artery disease or other cardiovascular disease, endocrinological (diabetes), neurologic, rheumatologic, or gastrointestinal disease)
* Acute illness or evidence of clinically significant active infection
* Pregnant, breast feeding or less than 6 months post-partum
* Taking prescribed psychotropic or central nervous system altering medications
* History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder, epilepsy or seizures
* Individuals who are currently undergoing a depressive episode. Can include those who are under treatment and not depressed currently.
* Excluded based upon the screening visit
* Use of nicotine
* Significant previous training or significant current practice in meditation
* Completed Mindfulness Based Stress Reduction (MBSR) in the past
* Current meditation practice. Judgment: Participants will be included or excluded at the PIs discretion due to wide variation in responses (e.g. 2 people answer yes, one practices mindfulness 2x/week for 2 years (exclude), the other attends regular religious services (include))
* Significant daily practice with other mind-body techniques
* Daily Yoga or Tai Chi Practice - exclude
* Other daily practice - judgment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT04857151
Study Brief:
Protocol Section:
NCT04857151