Post Treatment Lyme Disease Syndrome
Conditions
Keywords
Lyme DIsease, Kundalini Yoga
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.
Interventions
BEHAVIORALKundalini 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.
Sponsors
Research Foundation for Mental Hygiene, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory | Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted. | Self reported mood as measured by the 21 item Beck Depression Inventory. Range is 0-63 where higher scores indicate greater depression. |
| Applied Cognition General Concerns Short-form | Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted. | 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. |
| PROMIS Social Satisfaction | Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. . | 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. |
| Physical Functioning (as Measured by the PROMIS Physical Functioning Scale) | Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted. | 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) | Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 16 |
| 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.) | 10 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participants completed the treatment but the week 8 data not available. | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Subject started another treatment after wk 6 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Wait-List Controls | Meditation Group Therapy |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 14.9 | 62.6 years STANDARD_DEVIATION 14.5 | 48.5 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 26 participants | 10 participants | 16 participants |
| Sex: Female, Male Female | 15 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 10 |
| other Total, other adverse events | 0 / 16 | 0 / 10 |
| serious Total, serious adverse events | 0 / 16 | 0 / 10 |
Outcome results
Primary
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
Time frame: Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale) | 63.74 score on a scale | Standard Deviation 6.46 |
| Wait-List Controls | Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale) | 57.15 score on a scale | Standard Deviation 9.44 |
Primary
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.
Time frame: Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | Global Health (Self-reported Levels of Satisfaction With Global Health) | 2.58 score on a scale | Standard Deviation 1.3 |
| Wait-List Controls | Global Health (Self-reported Levels of Satisfaction With Global Health) | 2.62 score on a scale | Standard Deviation 0.74 |
Primary
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.
Time frame: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | Pain Interference (PROMIS Pain Interference Scale) | 61.08 score on a scale | Standard Deviation 11.68 |
| Wait-List Controls | Pain Interference (PROMIS Pain Interference Scale) | 52.9 score on a scale | Standard Deviation 8.28 |
Secondary
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.
Time frame: Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | Applied Cognition General Concerns Short-form | 31.66 score on a scale | Standard Deviation 7.77 |
| Wait-List Controls | Applied Cognition General Concerns Short-form | 37.6 score on a scale | Standard Deviation 4.4 |
Secondary
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.
Time frame: Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | Beck Depression Inventory | 16 score on a scale | Standard Deviation 10.72 |
| Wait-List Controls | Beck Depression Inventory | 11 score on a scale | Standard Deviation 8.19 |
Secondary
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
Time frame: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | General Symptom Questionnaire-30 (Self-reported Symptom Burden) | 54.9 score on a scale | Standard Deviation 26.48 |
| Wait-List Controls | General Symptom Questionnaire-30 (Self-reported Symptom Burden) | 29.5 score on a scale | Standard Deviation 16.32 |
Secondary
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.
Time frame: Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | Physical Functioning (as Measured by the PROMIS Physical Functioning Scale) | 37.41 score on a scale | Standard Deviation 8.56 |
| Wait-List Controls | Physical Functioning (as Measured by the PROMIS Physical Functioning Scale) | 41.26 score on a scale | Standard Deviation 4.63 |
Secondary
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.
Time frame: Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. .
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group Therapy | PROMIS Social Satisfaction | 38.75 score on a scale | Standard Deviation 6.85 |
| Wait-List Controls | PROMIS Social Satisfaction | 46.56 score on a scale | Standard Deviation 5.86 |