TerminatedNot Applicable

Meditation and Stretching for Post Treatment Lyme Disease Syndrome

Stopped: We aimed for 40, but slow enrollment and limited funds led us to terminate the study before completing full enrollment

United States26 participantsStarted 2015-11-01

Plain-language summary

The investigators wish to conduct a preliminary study to examine the efficacy of meditation among patients with Post Treatment Lyme Syndrome (PTLDS). Specifically, the investigators will use the breathing, meditation, and stretching techniques common to Kundalini Yoga practice. The investigators plan to assess the degree in which this practice can reduce Post-Treatment Lyme Disease symptoms. Because fatigue and pain are so common among patients with PTLDS, the primary focus of this study will be fatigue and pain. Secondary outcomes will include cognitive complaints, physical and mental functioning, medical utilization, somatic symptoms, and psychopathology.

Who can participate

Age range

18 Years – 65 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

. EM Rash seen by health professional
OR-
. History of physician diagnosed disseminated Lyme disease

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

Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale)

Timeframe: Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted.

Pain Interference (PROMIS Pain Interference Scale)

Timeframe: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted.

Global Health (Self-reported Levels of Satisfaction With Global Health)

Timeframe: Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted.

Trial details

NCT IDNCT02344537

SponsorResearch Foundation for Mental Hygiene, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-19

Results submitted2021-11-24

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