Clinical trial NCT02344537: Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Official title: Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Treatment Lyme Disease Syndrome
Keywords: Lyme DIsease
Kundalini Yoga
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
measure: Pain Interference (PROMIS Pain Interference Scale)
timeFrame: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted.
measure: 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.
Secondary outcomes:
measure: Physical Functioning (as Measured by the PROMIS Physical Functioning Scale)
timeFrame: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted.
measure: General Symptom Questionnaire-30 (Self-reported Symptom Burden)
timeFrame: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted.
measure: Beck Depression Inventory
timeFrame: Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted.
measure: PROMIS Social Satisfaction
timeFrame: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. .
measure: Applied Cognition General Concerns Short-form
timeFrame: Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted.
Other outcomes:
Locations:
city: Southport
country: United States
facility: Private Practice Office of Dr. Alexander
state: Connecticut
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Research Foundation for Mental Hygiene, Inc.
name: Brian A Fallon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins C. Yoga: intuition, preventive medicine, and treatment. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):563-8. doi: 10.1111/j.1552-6909.1998.tb02623.x.
citation: Carlson LE, Garland SN. Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Int J Behav Med. 2005;12(4):278-85. doi: 10.1207/s15327558ijbm1204_9.
citation: van der Lee ML, Garssen B. Mindfulness-based cognitive therapy reduces chronic cancer-related fatigue: a treatment study. Psychooncology. 2012 Mar;21(3):264-72. doi: 10.1002/pon.1890. Epub 2010 Dec 19.
citation: Grossman P, Kappos L, Gensicke H, D'Souza M, Mohr DC, Penner IK, Steiner C. MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology. 2010 Sep 28;75(13):1141-9. doi: 10.1212/WNL.0b013e3181f4d80d.