Post Treatment Lyme Disease SyndromeLMSNCT02344537
Meditation and Stretching for Post Treatment Lyme Disease Syndrome
A study testing Kundalini Yoga in people with Post Treatment Lyme Disease Syndrome, run by Research Foundation for Mental Hygiene, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Treatment Lyme Disease Syndrome
- What is being tested?
- Kundalini Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2015to 19 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Institute
New York, New York, 10032
Private Practice Office of Dr. Alexander
Southport, Connecticut, 06890
About this study
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.
Read the 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.
- Conditions
- Post Treatment Lyme Disease Syndrome
- Being tested
- Kundalini Yoga
- Keywords
- Lyme DIsease, Kundalini Yoga
- 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.
Kundalini YogaBehavioural
Also called Relaxation, stretching and meditation
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.
| Study group | Role | What they receive |
|---|---|---|
| Meditation Group Therapy | Experimental | 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. Receives: Behavioral: Kundalini Yoga |
| Wait-List Controls | No intervention | 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.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted.
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.
Measured: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted.
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.
Measured: Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted.
Secondary outcomes (5)
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.
Measured: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted.
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
Measured: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted.
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.
Measured: Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted.
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.
Measured: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. .
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.
Measured: Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start1 Nov 2015
- Primary completion19 May 2019
- Study completion19 May 2019
Why it stopped: We aimed for 40, but slow enrollment and limited funds led us to terminate the study before completing full enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Treatment Lyme Disease SyndromeStudies 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
- Masking
- None (open label)
- Enrolment
- 26 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, Research Foundation for Mental Hygiene, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344537
- Sponsor's protocol ID
- 6927
- Acronym
- LMS
- Status last verified
- Nov 2022
- First submitted
- 16 Jan 2015
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 9773368Carlson 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 16262547van 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.
PubMed 22383268Grossman 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 20876468
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation and Stretching for Post Treatment Lyme Disease Syndrome
- ClinicalTrials.gov ID
- NCT02344537
- Acronym / sponsor ID
- LMS / 6927
- Conditions
- Post Treatment Lyme Disease Syndrome
- Keywords
- Lyme DIsease, Kundalini Yoga
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We aimed for 40, but slow enrollment and limited funds led us to terminate the study before completing full enrollment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 19 May 2019 (actual)
- Study completion
- 19 May 2019 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 25 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Group Therapy | Experimental | Behavioral: Kundalini YogaKundalini 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. |
| Wait-List Controls | No intervention | –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.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- History of prior diagnosis of Lyme Disease at least 6 months prior to assessment
- -OR-
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Kundalini YogaAlso: Relaxation, stretching and meditationKundalini 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. | Behavioural | Meditation Group Therapy |
Primary outcome
Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale)
Time frame: Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted.
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)
Time frame: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted.
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)
Time frame: Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted.
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.
5 secondary outcomes
Physical Functioning (as Measured by the PROMIS Physical Functioning Scale)
Time frame: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted.
General Symptom Questionnaire-30 (Self-reported Symptom Burden)
Time frame: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted.
Beck Depression Inventory
Time frame: Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted.
PROMIS Social Satisfaction
Time frame: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. .
Applied Cognition General Concerns Short-form
Time frame: Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9773368Collins 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.
- 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 22383268van 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.
- 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.
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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
Research Foundation for Mental Hygiene, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kundalini Yoga in people with Post Treatment Lyme Disease Syndrome, run by Research Foundation for Mental Hygiene, Inc. at 2 sites in United States.
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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale) (time frame: Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted.). 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 NCT02344537, which also lists 4 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 25 Sep 2023.