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

Primary Purpose

Post Treatment Lyme Disease Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kundalini Yoga
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Treatment Lyme Disease Syndrome focused on measuring Lyme DIsease, Kundalini Yoga

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private Practice Office of Dr. Alexander
  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Meditation Group Therapy

Wait-List Controls

Arm Description

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.

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.)

Outcomes

Primary Outcome Measures

Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale)
Self-reported assessment of fatigue as measured by the 7 item PROMIS Fatigue Scale. The raw score range is 7-35. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater fatigue
Pain Interference (PROMIS Pain Interference Scale)
Self-reported assessment of pain interference as measured by the 6-item PROMIS Pain Interference Scale. The raw score range is 6-30. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater pain interference.
Global Health (Self-reported Levels of Satisfaction With Global Health)
Self-reported assessment of satisfaction with global health as measured by the 1st item ( a 5 point scale, range 1-5) on the PROMIS Global Heath Scale where higher scores indicate greater satisfaction with health.

Secondary Outcome Measures

Physical Functioning (as Measured by the PROMIS Physical Functioning Scale)
Self-reported assessment of physical functioning as measured by the PROMIS Physical Functioning 8 item Scale. Raw score range 8-40. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate better physical functioning.
General Symptom Questionnaire-30 (Self-reported Symptom Burden)
Self-reported assessment of symptom burden as measured by the 30 item multisystem Global Symptom Questionnaire. Range is 0-120 where higher scores indicate greater symptom burden
Beck Depression Inventory
Self reported mood as measured by the 21 item Beck Depression Inventory. Range is 0-63 where higher scores indicate greater depression.
PROMIS Social Satisfaction
Assesses satisfaction with social functioning. 8 item scale. Raw score range i 8-40). The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater satisfaction with social functioning.
Applied Cognition General Concerns Short-form
This self-report NeuroQoL measure assesses general concerns about cognition. This is an 8 item scale, with raw scores ranging from 8 to 40. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. Higher scores mean fewer cognitive concerns.

Full Information

First Posted
January 16, 2015
Last Updated
November 27, 2022
Sponsor
Research Foundation for Mental Hygiene, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02344537
Brief Title
Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Acronym
LMS
Official Title
Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
We aimed for 40, but slow enrollment and limited funds led us to terminate the study before completing full enrollment
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
May 19, 2019 (Actual)
Study Completion Date
May 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Treatment Lyme Disease Syndrome
Keywords
Lyme DIsease, Kundalini Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meditation Group Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-List Controls
Arm Type
No Intervention
Arm Description
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.)
Intervention Type
Behavioral
Intervention Name(s)
Kundalini Yoga
Other Intervention Name(s)
Relaxation, stretching and meditation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale)
Description
Self-reported assessment of fatigue as measured by the 7 item PROMIS Fatigue Scale. The raw score range is 7-35. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater fatigue
Time Frame
Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted.
Title
Pain Interference (PROMIS Pain Interference Scale)
Description
Self-reported assessment of pain interference as measured by the 6-item PROMIS Pain Interference Scale. The raw score range is 6-30. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater pain interference.
Time Frame
Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted.
Title
Global Health (Self-reported Levels of Satisfaction With Global Health)
Description
Self-reported assessment of satisfaction with global health as measured by the 1st item ( a 5 point scale, range 1-5) on the PROMIS Global Heath Scale where higher scores indicate greater satisfaction with health.
Time Frame
Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted.
Secondary Outcome Measure Information:
Title
Physical Functioning (as Measured by the PROMIS Physical Functioning Scale)
Description
Self-reported assessment of physical functioning as measured by the PROMIS Physical Functioning 8 item Scale. Raw score range 8-40. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate better physical functioning.
Time Frame
Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted.
Title
General Symptom Questionnaire-30 (Self-reported Symptom Burden)
Description
Self-reported assessment of symptom burden as measured by the 30 item multisystem Global Symptom Questionnaire. Range is 0-120 where higher scores indicate greater symptom burden
Time Frame
Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted.
Title
Beck Depression Inventory
Description
Self reported mood as measured by the 21 item Beck Depression Inventory. Range is 0-63 where higher scores indicate greater depression.
Time Frame
Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted.
Title
PROMIS Social Satisfaction
Description
Assesses satisfaction with social functioning. 8 item scale. Raw score range i 8-40). The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater satisfaction with social functioning.
Time Frame
Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. .
Title
Applied Cognition General Concerns Short-form
Description
This self-report NeuroQoL measure assesses general concerns about cognition. This is an 8 item scale, with raw scores ranging from 8 to 40. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. Higher scores mean fewer cognitive concerns.
Time Frame
Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of prior diagnosis of Lyme Disease at least 6 months prior to assessment EM Rash seen by health professional -OR- 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian A Fallon, MD
Organizational Affiliation
Research Foundation for Mental Hygiene, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Practice Office of Dr. Alexander
City
Southport
State/Province
Connecticut
ZIP/Postal Code
06890
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9773368
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.
Results Reference
background
PubMed Identifier
16262547
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.
Results Reference
background
PubMed Identifier
22383268
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.
Results Reference
background
PubMed Identifier
20876468
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.
Results Reference
background

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Meditation and Stretching for Post Treatment Lyme Disease Syndrome

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