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Trial record 8 of 70 for:    lyme

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.

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.

Condition or disease Intervention/treatment Phase
Post Treatment Lyme Disease Syndrome Behavioral: Kundalini Yoga Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease
U.S. FDA Resources

Arm Intervention/treatment
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.
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
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.)



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344537


Contacts
Contact: Brian A Fallon, MD 646-774-8052 baf1@columbia.edu
Contact: Camila Ibagon 646-774-8100 ci2205@columbia.edu

Locations
United States, Connecticut
Private Practice Office of Dr. Alexander Not yet recruiting
Southport, Connecticut, United States, 06890
Contact: Charles Alexander, MD    203-552-2371    CHIPALEX13@AOL.COM   
United States, New York
New York State Psychiatric Institute Not yet recruiting
New York, New York, United States, 10032
Contact: Camila Ibagon, BS    646-774-8100    ci2205@columbia.edu   
Contact: Shreya Doshi, MA    646-774-7535    sd2698@tc.columbia.edu   
Sub-Investigator: Charles Alexander, MD         
Principal Investigator: Brian A Fallon, MD         
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Brian A Fallon, MD Research Foundation for Mental Hygiene, Inc.

Publications:
Responsible Party: Brian Fallon, Professor of Psychiatry, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT02344537     History of Changes
Other Study ID Numbers: 6927
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Brian Fallon, Research Foundation for Mental Hygiene, Inc.:
Lyme DIsease
Kundalini Yoga

Additional relevant MeSH terms:
Syndrome
Lyme Disease
Disease
Pathologic Processes
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections