search
Back to results

Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study

Primary Purpose

Post-Treatment Lyme Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Meditation
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 focused on measuring Lyme disease, Kundalini Yoga, Meditation, Chronic Lyme Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Continued Lyme disease-related symptoms despite prior antibiotic treatment
  2. Current symptoms of either fatigue or pain that is moderate in severity
  3. Treatment history over the prior 8 weeks: Either no treatment or it's been stable
  4. Willingness to not start a new medical or psychiatric treatment during the 8 study weeks
  5. Access to a smart phone
  6. Age 18-70 and able to read and understand English
  7. Lives in the United States

Exclusion Criteria:

  1. Current severe depression, Substance abuse in the last 6 months, pain disorder treated with an opiate-based medication, or current or past episodes of Psychosis or Bipolar disorder.
  2. Individuals with physical disability that might make study participation difficult.
  3. 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
  4. Unwillingness to complete questionnaires on-line or dedicate thirty minutes daily to meditation and/or stretching
  5. Unwillingness to continue in the study for 8 weeks by completing self-report evaluations if randomly assigned to the wait-list rather than to Kundalini Yoga or Meditation.
  6. Individuals unwilling to delay starting any new Mind-body practice (e.g., meditation , Yoga) until after the 8 weeks of the study have been completed.
  7. Individuals with a current daily practice of Mindfulness-based stress reduction or those who currently have a daily practice of meditation or yoga
  8. Individuals unwilling to provide records of prior diagnosis and treatment for Lyme disease
  9. Individuals unwilling to accept push notifications to their smartphone or computer

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Meditation

    Kundalini Yoga

    Treatment as Usual

    Arm Description

    This is a daily 15 minute meditation with guided breathing. Accessible through an app.

    This is a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.

    This group will serve as the comparison to assess the efficacy of the active treatments in that no study treatment will be provided. The participants will be asked to not start new treatments during the 8 weeks of the study.

    Outcomes

    Primary Outcome Measures

    Fatigue Severity Scale
    A Fatigue impact measure
    General Symptom Questionnaire-30
    A self-report measure of multi-system symptom burden
    Quality of Life Experience Scale
    A measure of qualify of life

    Secondary Outcome Measures

    Pain Visual Analog Scale
    A self-report measure of pain severity
    Applied Cognition scale
    A self-report measure of cognitive function
    PROMIS-29
    A self-report measure of seven symptom and functional domains
    SF-12
    A self-report measure of physical and mental functioning

    Full Information

    First Posted
    April 14, 2020
    Last Updated
    November 12, 2021
    Sponsor
    Research Foundation for Mental Hygiene, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04349605
    Brief Title
    Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study
    Official Title
    Meditation and Yoga for Patients With Persistent Symptoms After Lyme Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn given new information indicating a new study design would be preferable
    Study Start Date
    June 20, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    March 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This randomized, controlled study examines whether a daily practice over 8 weeks of Kundalini Yoga or Meditation can help to reduce pain and/or fatigue among patients with symptoms that persist despite prior antibiotic treatment.
    Detailed Description
    Research reports indicate that approximately 5-20% of patients treated for Lyme disease with the IDSA-recommended 2-4 week course of antibiotics will continue to have symptoms of fatigue, pain, cognitive problems, and/or joint and muscle aches despite prior antibiotic treatment. The symptoms can last months to years after treatment. The medical community officially calls this condition "Post-treatment Lyme disease Syndrome" (PTLDS) when patients meet strict inclusion and exclusion criteria. The patient community commonly calls this condition "chronic Lyme disease" (CLD). Although there is debate about the exact cause of these symptoms, there is widespread agreement that this is a growing public health problem as an increasing number of patients are suffering with symptoms of pain, fatigue, and cognitive problems ("brain fog") despite having received not just the standard treatment courses but even after many courses of antibiotics and other interventions. While antibiotic therapy is the key to the treatment of active infection, other approaches are needed for those patients whose symptoms persist despite the best antibiotic treatment efforts. Alternative treatments that can assuage fatigue, muscle and joint pains, and improve cognitive function are urgently needed. Recent studies indicate that mind body practices (e.g., meditation; Kundalini Yoga) can be helpful strategy in reducing chronic symptoms, such as pain, fatigue, and poor mental focus. This study examines the efficacy of two mind-body therapies among patients with PTLDS and CLD: a) the breathing, meditation, and stretching techniques common to Kundalini Yoga practice; and b) meditation and breathing techniques common to Western meditation practices. We plan to assess the degree to which these practices can reduce the chronic symptoms compared to a wait-list control group. Because fatigue and multi-system symptoms are so common among patients with PTLDS or CLD, these will be the primary focus of this study. Primary outcome will be improvement in these self-reported core symptoms and in self-reported quality of life. Secondary outcomes will assess cognitive complaints, pain, physical and mental functioning, somatic symptoms, and psychopathology. This will be an on-line study. During this study, patients will be screened through an on-line process, review consent, and complete self-report questionnaires. 225 patients will be enrolled. Of these, 75 will be randomly assigned to Kundalini yoga and meditation therapy, 75 will be assigned to a meditation & mindfulness App, and 75 will be assigned to a "treatment as usual" wait-list. Assessments will be conducted weekly for 8 weeks; there will also be a 6 month follow-up by questionnaire. Study participants randomized to the "treatment as usual" control group will be offered the option of receiving guided on-line meditation at the end of the 8 weeks. Should this study find evidence suggesting that either meditation therapy and/or Kundalini Yoga are helpful in reducing the symptoms that persist after Lyme disease treatment, this would be a valuable and welcome research finding.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Treatment Lyme Disease
    Keywords
    Lyme disease, Kundalini Yoga, Meditation, Chronic Lyme Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants are randomly assigned to one of the three treatment arms of the study - Kundalini Yoga, Meditation, or Treatment as usual.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Meditation
    Arm Type
    Experimental
    Arm Description
    This is a daily 15 minute meditation with guided breathing. Accessible through an app.
    Arm Title
    Kundalini Yoga
    Arm Type
    Experimental
    Arm Description
    This is a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.
    Arm Title
    Treatment as Usual
    Arm Type
    No Intervention
    Arm Description
    This group will serve as the comparison to assess the efficacy of the active treatments in that no study treatment will be provided. The participants will be asked to not start new treatments during the 8 weeks of the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Meditation
    Intervention Description
    Meditation involves guided breathing and mindfulness training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Kundalini Yoga
    Intervention Description
    Kundalini Yoga involves stretching, guided breathing and meditation
    Primary Outcome Measure Information:
    Title
    Fatigue Severity Scale
    Description
    A Fatigue impact measure
    Time Frame
    Up to 24 weeks
    Title
    General Symptom Questionnaire-30
    Description
    A self-report measure of multi-system symptom burden
    Time Frame
    Up to 24 weeks
    Title
    Quality of Life Experience Scale
    Description
    A measure of qualify of life
    Time Frame
    Up to 24 weeks
    Secondary Outcome Measure Information:
    Title
    Pain Visual Analog Scale
    Description
    A self-report measure of pain severity
    Time Frame
    Up to 24 weeks
    Title
    Applied Cognition scale
    Description
    A self-report measure of cognitive function
    Time Frame
    Up to 24 weeks
    Title
    PROMIS-29
    Description
    A self-report measure of seven symptom and functional domains
    Time Frame
    Up to 24 weeks
    Title
    SF-12
    Description
    A self-report measure of physical and mental functioning
    Time Frame
    Up to 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Continued Lyme disease-related symptoms despite prior antibiotic treatment Current symptoms of either fatigue or pain that is moderate in severity Treatment history over the prior 8 weeks: Either no treatment or it's been stable Willingness to not start a new medical or psychiatric treatment during the 8 study weeks Access to a smart phone Age 18-70 and able to read and understand English Lives in the United States Exclusion Criteria: Current severe depression, Substance abuse in the last 6 months, pain disorder treated with an opiate-based medication, or current or past episodes of Psychosis or Bipolar disorder. 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 on-line or dedicate thirty minutes daily to meditation and/or stretching Unwillingness to continue in the study for 8 weeks by completing self-report evaluations if randomly assigned to the wait-list rather than to Kundalini Yoga or Meditation. Individuals unwilling to delay starting any new Mind-body practice (e.g., meditation , Yoga) until after the 8 weeks of the study have been completed. Individuals with a current daily practice of Mindfulness-based stress reduction or those who currently have a daily practice of meditation or yoga Individuals unwilling to provide records of prior diagnosis and treatment for Lyme disease Individuals unwilling to accept push notifications to their smartphone or computer -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian A Fallon, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    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
    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
    PubMed Identifier
    24804619
    Citation
    Khalsa MK, Greiner-Ferris JM, Hofmann SG, Khalsa SB. Yoga-enhanced cognitive behavioural therapy (Y-CBT) for anxiety management: a pilot study. Clin Psychol Psychother. 2015 Jul-Aug;22(4):364-71. doi: 10.1002/cpp.1902. Epub 2014 May 7.
    Results Reference
    background
    PubMed Identifier
    31780963
    Citation
    Shannahoff-Khalsa D, Fernandes RY, Pereira CAB, March JS, Leckman JF, Golshan S, Vieira MSR, Polanczyk GV, Miguel EC, Shavitt RG. Kundalini Yoga Meditation Versus the Relaxation Response Meditation for Treating Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Front Psychiatry. 2019 Nov 11;10:793. doi: 10.3389/fpsyt.2019.00793. eCollection 2019.
    Results Reference
    background
    PubMed Identifier
    29331704
    Citation
    Wang YY, Li XH, Zheng W, Xu ZY, Ng CH, Ungvari GS, Yuan Z, Xiang YT. Mindfulness-based interventions for major depressive disorder: A comprehensive meta-analysis of randomized controlled trials. J Affect Disord. 2018 Mar 15;229:429-436. doi: 10.1016/j.jad.2017.12.093. Epub 2018 Jan 3.
    Results Reference
    background

    Learn more about this trial

    Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study

    We'll reach out to this number within 24 hrs