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Stopped: Withdrawn given new information indicating a new study design would be preferable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 range18 Years – 70 Years

SexALL

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
✕. 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

What they're measuring

Fatigue Severity Scale

Timeframe: Up to 24 weeks

General Symptom Questionnaire-30

Timeframe: Up to 24 weeks

Quality of Life Experience Scale

Timeframe: Up to 24 weeks

Trial details

NCT IDNCT04349605

SponsorResearch Foundation for Mental Hygiene, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Post-Treatment Lyme Disease trials

Who can participate

Age range18 Years – 70 Years

SexALL

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
✕. 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