Not provided
Not provided
Not provided
Not provided
We aimed for 40, but slow enrollment and limited funds led us to terminate the study before completing full enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kundalini Yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian A Fallon, MD | Research Foundation for Mental Hygiene, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice Office of Dr. Alexander | Southport | Connecticut | 06890 | United States | ||
| New York State Psychiatric Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9773368 | Background | 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. | |
| 16262547 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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.) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted. |
|
Participants were followed for adverse events over an 8 week period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Fallon, MD | New York State Psychiatric Institute | 6467748052 | brian.fallon@nyspi.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2021 | Nov 24, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2019 | Nov 24, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077342 | Post-Lyme Disease Syndrome |
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 | 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. | 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. | 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. | Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted. |
| New York |
| New York |
| 10032 |
| United States |
| 22383268 | Background | 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. |
| 20876468 | Background | 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. |
| Participants completed the treatment but the week 8 data not available. |
|
| BG001 | 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.) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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.) |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted. |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. . |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted. |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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.) | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |