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:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04349605
Eligibility Criteria:
Inclusion Criteria:
1. Continued Lyme disease-related symptoms despite prior antibiotic treatment
2. Current symptoms of either fatigue or pain that is moderate in severity
3. Treatment history over the prior 8 weeks: Either no treatment or it's been stable
4. Willingness to not start a new medical or psychiatric treatment during the 8 study weeks
5. Access to a smart phone
6. Age 18-70 and able to read and understand English
7. Lives in the United States
Exclusion Criteria:
1. Current severe depression, Substance abuse in the last 6 months, pain disorder treated with an opiate-based medication, or current or past episodes of Psychosis or Bipolar disorder.
2. Individuals with physical disability that might make study participation difficult.
3. Individuals whose current medical status is so severe or unstable that participation in the study (and not receiving new treatments from other providers) would be difficult
4. Unwillingness to complete questionnaires on-line or dedicate thirty minutes daily to meditation and/or stretching
5. Unwillingness to continue in the study for 8 weeks by completing self-report evaluations if randomly assigned to the wait-list rather than to Kundalini Yoga or Meditation.
6. Individuals unwilling to delay starting any new Mind-body practice (e.g., meditation , Yoga) until after the 8 weeks of the study have been completed.
7. Individuals with a current daily practice of Mindfulness-based stress reduction or those who currently have a daily practice of meditation or yoga
8. Individuals unwilling to provide records of prior diagnosis and treatment for Lyme disease
9. Individuals unwilling to accept push notifications to their smartphone or computer
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04349605
Study Brief:
Protocol Section:
NCT04349605