Meditation and Stretching for Post Treatment Lyme Disease Syndrome

The CDC reports that approximately 10-20% of patients treated for Lyme disease with the
IDSA-recommended 2-4 week course of antibiotics will continue to have symptoms of fatigue,
pain, or joint and muscle aches despite prior antibiotic treatment. The symptoms can last
months or even years after treatment. The medical community officially calls this condition
"Post-treatment Lyme disease Syndrome" (PTLDS) but some have called it "chronic Lyme
disease." Because some patients with PTLDS continue to have ongoing symptoms despite many
additional courses of antibiotics beyond the standard course, alternative non-antibiotic
treatment programs need to be explored. The proposed study seeks to evaluate the efficacy of
meditation among those patients that have been previously treated for Lyme disease but are
still continuing to experience prominent symptoms of fatigue and/or pain.

During this study, patients will be screened initially over the telephone to assess
eligibility, sign consent with the study treating psychiatrist, and complete self-report
questionnaires. Forty patients will be enrolled. Of these, 20 will be randomly assigned to
meditation group therapy and 20 will be assigned to a wait-list. Assessments will be
conducted prior to treatment, at 4 weeks and at 8 weeks. There will also be a 6 month
follow-up by questionnaire and telephone interview. Study participants randomized to the
wait-list control group will then be offered, after 8 weeks, the option of joining a
meditation group for 8 weeks. Each meditation group will be composed of 6-8 subjects.

Should this study find evidence suggesting that meditation therapy is helpful in reducing
the symptoms of PTLDS, this would be a valuable finding that would lead to a larger study as
it has important public health implications for many individuals now quite disabled with
these chronic symptoms.

Inclusion Criteria:

- History of prior diagnosis of Lyme Disease at least 6 months prior to assessment

1. EM Rash seen by health professional

-OR-

2. History of physician diagnosed disseminated Lyme disease

- Previously treated for Lyme Disease with antibiotics appropriate for stage of disease

- Current symptoms of PTLDS started within 6 months after getting Lyme disease

- Current symptoms have been present for at least the last 6 months.

- Between the ages of 18 and 65, English speaking, male or female

- Primary complaint of fatigue or pain meeting predetermined severity criteria

- Individuals whose medical and/or psychiatric treatment has been stable for the prior
8 weeks

- Individuals who agree to not start a new treatment for PTLS during the course of the
study; this applies to both those assigned to the control wait list group and those
assigned to the experimental group.

Exclusion Criteria:

- Individual with another reasonable medical explanation (other than Lyme) that might
better account for current fatigue or pain (e.g., Thyroid Disease, Anemia, Rheumatoid
Arthritis)

- Individual with a major psychiatric diagnosis that might make study participation
difficult (e.g, Dissociative Identity Disorder, Psychosis, Post Traumatic Stress
Disorder, Substance abuse with the prior 6 months, Pain Disorder treated with
opiate-based medication)

- Individuals with severe depression

- 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, speak with study research assistant, or
dedicate twenty minutes daily to meditation and stretching

- Suicide attempts within the last 6 months or current suicidal thoughts

- Individuals unwilling to delay starting optional treatment for Lyme disease for the
duration of the study

- Individuals with a prior lifetime practice of at least one month of daily practice of
MBSR or mindfulness or those who currently practice daily meditation or yoga