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Meditation and Stretching for Post Treatment Lyme Disease Syndrome (LMS)

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ClinicalTrials.gov Identifier: NCT02344537
Recruitment Status : Unknown
Verified January 2015 by Brian Fallon, Research Foundation for Mental Hygiene, Inc..
Recruitment status was:  Not yet recruiting
First Posted : January 26, 2015
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Brian Fallon, Research Foundation for Mental Hygiene, Inc.

January 16, 2015
January 26, 2015
January 27, 2015
January 2015
January 2017   (Final data collection date for primary outcome measure)
  • Fatigue (Self-reported changes in the levels of fatigue as measured by the PROMIS Fatigue Scale) [ Time Frame: 8 weeks ]
    Self-reported changes in the levels of fatigue as measured by the PROMIS Fatigue Scale
  • Pain (Self-reported changes in the levels of pain as measured by the PROMIS Pain Interference Scale) [ Time Frame: 8 weeks ]
    Self-reported changes in the levels of pain as measured by the PROMIS Pain Interference Scale
  • Global Health (Self-reported changes in the levels of satisfaction with global health as measured by the PROMIS Global Heath Satisfaction Scale) [ Time Frame: 8 weeks ]
    Self-reported changes in the levels of satisfaction with global health as measured by the PROMIS Global Heath Satisfaction Scale
Same as current
Complete list of historical versions of study NCT02344537 on ClinicalTrials.gov Archive Site
  • Physical & Social Functioning (Self-reported changes in the levels of satisfaction with physical and social functioning as measured by the PROMIS Physical Functioning Scale & Social Satisfaction Scale) [ Time Frame: 8 weeks ]
    Self-reported changes in the levels of satisfaction with physical and social functioning as measured by the PROMIS Physical Functioning Scale & Social Satisfaction Scale
  • Multisystemic Symptoms (Self-reported changes in symptom severity as indicated in the Multisystem Symptom Questionnaire) [ Time Frame: 8 weeks ]
    Self-reported changes in symptom severity as indicated in the Multisystem Symptom Questionnaire
  • Mood (Anxiety and/or Depression) (as measured by the Beck Depression Inventory, PROMIS Depression & Anxiety Scales) [ Time Frame: 8 weeks ]
    Self reported changes in mood as measured by the Beck Depression Inventory, PROMIS Depression & Anxiety Scales
  • Acceptance of Treatment (as indicated by the patient log) [ Time Frame: 8 weeks ]
    Self reported time spent on practicing meditation across 8 weeks as indicated by the patient log.
  • Medical Utilization [ Time Frame: 6 month after treatment completion ]
    Assess medical utililization during the 3 month interval prior to treatment and prior to 6 month follow-up
Same as current
Not Provided
Not Provided
 
Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Meditation and Stretching for Post Treatment Lyme Disease Syndrome
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Post Treatment Lyme Disease Syndrome
Behavioral: Kundalini Yoga
Kundalini Yoga incorporates mindfulness practice with a triad of stretching, breathing, and meditation. The three components of treatment consist of muscular relaxation/stretching exercises, a meditation period characterized by a directed breathing exercise, and then a guided meditation.
Other Name: Relaxation, stretching and meditation
  • Experimental: Meditation Group Therapy
    Kundalini Yoga incorporates mindfulness practice with a triad of stretching, breathing, and meditation. The three components of treatment consist of muscular relaxation/stretching exercises, a meditation period characterized by a directed breathing exercise, and then a guided meditation.
    Intervention: Behavioral: Kundalini Yoga
  • No Intervention: Wait-List Controls
    The wait-list group will not take part in study treatment (daily meditation or stretching) during the study wait of 8 weeks in order for us to compare change related to the study intervention to change associated with no active treatment ( treatment-as-usual). (After completing 8 weeks of no study treatment as part of the wait-list group, these patients will be offered the opportunity to receive 8 weeks of treatment.)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
Not Provided
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02344537
6927
No
Not Provided
Not Provided
Brian Fallon, Research Foundation for Mental Hygiene, Inc.
Research Foundation for Mental Hygiene, Inc.
Not Provided
Principal Investigator: Brian A Fallon, MD Research Foundation for Mental Hygiene, Inc.
Research Foundation for Mental Hygiene, Inc.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP