Post-Treatment Lyme DiseaseNCT04349605
Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study
A study testing Meditation and Kundalini Yoga in people with Post-Treatment Lyme Disease, run by Research Foundation for Mental Hygiene, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Treatment Lyme Disease
- What is being tested?
- Meditation and Kundalini Yoga
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
- -
About this study
Official title: Meditation and Yoga for Patients With Persistent Symptoms After Lyme Disease
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.
Read the 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.
- Conditions
- Post-Treatment Lyme Disease
- Being tested
- Meditation, Kundalini Yoga
- Keywords
- Lyme disease, Kundalini Yoga, Meditation, Chronic Lyme Disease
- Medical subject headings
- Post-Lyme Disease Syndrome, Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Meditation involves guided breathing and mindfulness training.
Kundalini YogaBehavioural
Kundalini Yoga involves stretching, guided breathing and meditation
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Experimental | This is a daily 15 minute meditation with guided breathing. Accessible through an app. Receives: Behavioral: Meditation |
| Kundalini Yoga | Experimental | This is a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer. Receives: Behavioral: Kundalini Yoga |
| Treatment as Usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
A Fatigue impact measure
Measured: Up to 24 weeks
General Symptom Questionnaire-30
A self-report measure of multi-system symptom burden
Measured: Up to 24 weeks
Quality of Life Experience Scale
A measure of qualify of life
Measured: Up to 24 weeks
Secondary outcomes (4)
Pain Visual Analog Scale
A self-report measure of pain severity
Measured: Up to 24 weeks
Applied Cognition scale
A self-report measure of cognitive function
Measured: Up to 24 weeks
PROMIS-29
A self-report measure of seven symptom and functional domains
Measured: Up to 24 weeks
SF-12
A self-report measure of physical and mental functioning
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start20 Jun 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: Withdrawn given new information indicating a new study design would be preferable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-Treatment Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian A Fallon, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Brian A Fallon, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349605
- Sponsor's protocol ID
- 7613
- Status last verified
- Nov 2021
- First submitted
- 14 Apr 2020
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16262547Grossman 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.
PubMed 20876468Khalsa 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.
PubMed 24804619Shannahoff-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.
PubMed 31780963Wang 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.
PubMed 29331704
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation and Yoga for Patients With Persistent Symptoms After Lyme Disease
- ClinicalTrials.gov ID
- NCT04349605
- Acronym / sponsor ID
- 7613
- Conditions
- Post-Treatment Lyme Disease
- Keywords
- Lyme disease, Kundalini Yoga, Meditation, Chronic Lyme Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn given new information indicating a new study design would be preferable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- 20 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of the three treatment arms of the study - Kundalini Yoga, Meditation, or Treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: MeditationThis is a daily 15 minute meditation with guided breathing. Accessible through an app. |
| Kundalini Yoga | Experimental | Behavioral: Kundalini YogaThis is a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer. |
| Treatment as Usual | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationMeditation involves guided breathing and mindfulness training. | Behavioural | Meditation |
| Kundalini YogaKundalini Yoga involves stretching, guided breathing and meditation | Behavioural | Kundalini Yoga |
Primary outcome
Fatigue Severity Scale
Time frame: Up to 24 weeks
A Fatigue impact measure
General Symptom Questionnaire-30
Time frame: Up to 24 weeks
A self-report measure of multi-system symptom burden
Quality of Life Experience Scale
Time frame: Up to 24 weeks
A measure of qualify of life
4 secondary outcomes
Pain Visual Analog Scale
Time frame: Up to 24 weeks
Applied Cognition scale
Time frame: Up to 24 weeks
PROMIS-29
Time frame: Up to 24 weeks
SF-12
Time frame: Up to 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Background: PubMed 16262547Carlson 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.
- Background: PubMed 20876468Grossman 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.
- Background: PubMed 24804619Khalsa 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.
- Background: PubMed 31780963Shannahoff-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.
- Background: PubMed 29331704Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian A Fallon, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Meditation and Kundalini Yoga in people with Post-Treatment Lyme Disease, run by Research Foundation for Mental Hygiene, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04349605, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.