Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study (NCT04349605) | Clinical Trial Compass
WithdrawnNot Applicable
Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study
Stopped: Withdrawn given new information indicating a new study design would be preferable
0Started 2021-06-20
Plain-language summary
This randomized, controlled study examines whether a daily practice over 8 weeks of Kundalini Yoga or Meditation can help to reduce pain and/or fatigue among patients with symptoms that persist despite prior antibiotic treatment.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Continued Lyme disease-related symptoms despite prior antibiotic treatment
. Current symptoms of either fatigue or pain that is moderate in severity
. Treatment history over the prior 8 weeks: Either no treatment or it's been stable
. Willingness to not start a new medical or psychiatric treatment during the 8 study weeks
. Access to a smart phone
. Age 18-70 and able to read and understand English
. Lives in the United States
Exclusion criteria
. 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.
. Individuals with physical disability that might make study participation difficult.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue Severity Scale
Timeframe: Up to 24 weeks
2
General Symptom Questionnaire-30
Timeframe: Up to 24 weeks
3
Quality of Life Experience Scale
Timeframe: Up to 24 weeks
Trial details
NCT IDNCT04349605
SponsorResearch Foundation for Mental Hygiene, Inc.
. Unwillingness to complete questionnaires on-line or dedicate thirty minutes daily to meditation and/or stretching
. 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.
. 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.
. Individuals with a current daily practice of Mindfulness-based stress reduction or those who currently have a daily practice of meditation or yoga
. Individuals unwilling to provide records of prior diagnosis and treatment for Lyme disease