Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Phase: NA
Conditions: Post Treatment Lyme Disease Syndrome
Sponsor: Research Foundation for Mental Hygiene, Inc.

Signed copy on file at IRB 
 
             v. 02/26/19 
New York State Psychiatric Institute 
Institutional Review Board 
 
November 5, 2021 
 
To: 
 
Dr. Brian Fallon 
From:  
Dr. Edward Nunes, Co-Chair 
 
 
Dr. Agnes Whitaker, Co-Chair 
 
 
 
 
Subject: 
Approval Notice: Continuation Expedited per 45CFR46.110(b)(1)(f)(7) 
 
Your protocol # 6927 entitled: MEDITATION AND STRETCHING FOR POST TREATMENT LYME 
DISEASE SYNDROME Protocol version date 11/05/2021 has been approved by the New York State 
Psychiatric Institute - Columbia University Department of Psychiatry Institutional Review Board 
from November 7, 2021 to November 6, 2022.  
 
Consent requirements:  
     √  Not applicable: Data Analysis Only 
    45CFR46.116 (f)(3) waiver of consent for closed record/chart review 
      Signature by the person(s) obtaining consent is required to document the consent process 
      Documentation of an independent assessment of the participant’s capacity to consent is also 
required. 
Approved for recruitment of subjects who lack capacity to consent:  No  Yes    
 
 
Field Monitoring Requirements:  Routine  Special: ___________________  
 
 
  Only copies of consent documents that are currently approved by the IRB may be used to obtain 
consent for participation in this study. 
  A progress report and application for continuing review is required 2 months prior to the 
expiration date of IRB approval. 
  Changes to this research may not be initiated without the review and approval of the IRB except 
when necessary to eliminate immediate hazards to participants.  
  All serious and/or unanticipated problems or events involving risks to subjects or others must be 
reported immediately to the IRB.  Please refer to the PI-IRB website at http://irb.nyspi.org for 
Adverse Event Reporting Procedures and additional reporting requirements.    
 
 
 
 
EN/AHW/alw 

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Protocol Title:
Meditation and Stretching for Post 
Treatment Lyme Disease Syndrome
Protocol Number:
6927
First Approval:
11/07/2014
Expiration Date:
11/06/2022
Version Date:
11/05/2021
Contact Principal Investigator:
Brian Fallon, MD
Email: baf1@columbia.edu
Telephone: 646-774-8052
Co-Investigator(s):
Charles Alexander
Research Chief:
Helen Simpson, MD
Cover Sheet
Choose ONE option from the following that is applicable to your study
If you are creating a new protocol, select "I am submitting a new protocol." As 5 Year Renewals are no 
longer required, this option remains for historical purposes.
I am submitting an annual continuation without modifications 
Department & Unaffiliated Personnel
Department
What Department does the PI belong to?
Clinical Therapeutics
Within the department, what Center or group are you affiliated with, if any? 
Center for the Study of Neuroinflammatory Disorders & Biobehavioral Medicine
Unaffiliated Personnel
List investigators, if any, who will be participating in this protocol but are not affiliated with New York 
State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation.
Dr. Charles Alexander, MD (Private Practice, Southport CT)

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Application for Continuation of Research
Status
Current Status of Study: 
All research interventions were completed. Only data analysis is ongoing.
Summary of Experiences to Date
Please provide a summary of scientific progress of the study and the experience of research participants, to 
date. This requirement is designed to allow for the investigator and the IRB to reassess the study’s risks and 
benefits in terms of developments in the field, changing practice patterns, and new IRB policies and 
procedures.
The data analysis has been finished. Our analysis is nearly completed. An article titled "Kundalini yoga for 
post-treatment Lyme disease: A randomized controlled pilot study"  currently is being prepared for 
submission. 
 
Funding
Have there been any changes in funding status since the prior approval? 
No
Have the principal investigator and other investigators made all required disclosures of financial interest in 
the study sponsor/product?
Yes
Summary
Have there been any study findings, recent literature, or untoward events occuring here or at other sites in 
the past year which might affect the analysis of the safety, risks or benefits of study participation? 
No
Have there been any serious adverse events (serious and/or unanticipated problems involving risks to 
subjects or others at this site which occured in the past year)? 
No
Have all study staff with a significant role in the design or implementation of the human subject components 
of this study received required training in human research subject protections?
Yes
Is the study covered by a certificate of confidentiality? 
No
Overall Progress
Approved sample size

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40
Total number of participants enrolled to date
26
Number of participants who have completed the study to date 
23
Have there been any significant deviations from the anticipated study recruitment, retention or completion 
estimates? 
No
Comments / additional information 
Sample Demographics
Specify population
40
Total number of participants enrolled from this population to date 
26
Gender, Racial and Ethnic Breakdown 
Sex:
Male, n = 12 (46.2%)
Female, n = 13 (50.0%)
Missing, n = 1 (3.8%)
Ethnicity:
White (non-Hispanic), n = 19 (73.1%)
Black (non-Hispanic), n = 1 (3.8%)
Hispanic, n = 1 (3.8%)
Missing, n = 5 (19.2%)
Summary of Current Year's Enrollment and Drop-out 
Number of participants who signed consent in the past year
0
Did the investigator withdraw participants from the study? 
No
Did participants decide to discontinue study involvement? 
No
Procedures
To create the protocol summary form, first indicate if this research will include any of the following 
procedures
   Psychiatric Assessment
   Psychotherapy Trial

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   Internet-based Data Collection or Transmission
Population
Indicate which of the following populations will be included in this research
   Medically Ill Subjects
   Adults
   Adults over 50
Research Support/Funding
Will an existing internal account be used to support the project?
No
Is the project externally funded or is external funding planned?
No
Study Location
Indicate if the research is/will be conducted at any of the following
   NYSPI
This protocol describes research conducted by the PI at other facilities/locations
Yes
   Community Sources
Community Sources
Type in location(s)
The oversight, screening, preliminary consent review, data entry, research file monitoring and preparation, 
data management, and analysis will take place at the NYSPI.  The actual in-person final signing of consent 
and conduct of therapy with study participants will be conducted in the private practice office of Dr. Charles 
Alexander in Southport Connecticut. 
Lay Summary of Proposed Research 
Lay Summary of Proposed Research
The CDC reports that approximately 10-20% of patients treated for Lyme disease with the 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 up to 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” (CLD). High clinical suspicion of Chronic Lyme Disease 

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may even be found in patients that do not meet meet the criteria of a CDC based diagnosis; that is, 
having a positive blood test, rash, or characteristic symptoms. The exact cause of these symptoms is 
unknown; the IDSA has concluded that the symptoms are likely lingering effects of the previous infection 
and that further antibiotic therapy is unwarranted. Despite the IDSA’s recommendations, many patients 
choose to receive additional courses of antibiotic therapy.  Some of these patients continue to experience 
symptoms despite the additional antibiotic therapy; persistent symptoms among many within this subgroup 
of post-treatment patients are more likely due to a post-infectious process and for these patients new 
treatment approaches are needed. The common symptoms of post-treatment Lyme disease include muscle 
and joint pains, memory problems, sleep disturbance, cognitive problems (“brain fog”), and fatigue. 
 
Alternative treatments that can assuage fatigue, muscle and joint pains, and improve cognitive function are 
urgently needed. Recent studies indicate that meditation can be a helpful strategy in reducing muscle pain 
and improving energy among patients with other chronic musculoskeletal disorders, such as fibromyalgia. 
We wish to conduct a preliminary study to examine the efficacy of meditation among patients with 
PTLDS and CLD. Specifically, we will use the breathing, meditation, and stretching techniques common to 
Kundalini Yoga practice.  We plan to assess the degree in which this practice can reduce Post-Treatment 
Lyme Disease and Chronic Lyme Disease symptoms. Because fatigue and pain are so common among 
patients with PTLDS or CLD, 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. 
During this study, patients will be screened intially 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. 
Background, Significance and Rationale
Background, Significance and Rationale
       The proposed study seeks to evaluate the efficacy of meditation among patients previously treated for 
Lyme disease but continuing to experience prominent symptoms of fatigue and/or pain. Study participants 
will have an established diagnosis of Lyme disease, prior treatment for the disease, and persistent 
impairment or distress that could reasonably be attributed to Lyme disease, as measured by self-report 
questionnaires.
      The usefulness of meditation in patients with Post-Treatment Lyme Disease and Chronic Lyme Disease 
is uncertain. However, previous research has demonstrated the value of mindfulness and meditation in the 
alleviation of physical symptoms of chronic disease in other patient populations. Specifically, these 
practices have demonstrated benefit in the areas of fatigue, affect, and pain management.
       Meditation involves a combination of muscular activity, directed focus on the self, breathing and energy 

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(Collins C, 1998). This mind-body fitness has been found to foster physical, mental and emotional health 
through the use of stretching, breathing practices, concentration and meditation (Ross & Thompson, 2010). 
Mindfulness, the practice of maintaining moment-to-moment awareness and accepting experiences as they 
are without judgment or reactivity, is at the heart of most meditation practice and the center of many 
alternative clinical interventions (Carlson & Garland, 2005) .
       The benefits of mindfulness and meditation have been demonstrated in multiple patient groups. Carlson 
and Garland (2005) found significant reductions in fatigue, sleep disturbances, stress and mood disturbances 
as well as significant increases in sleep quality in a population of cancer patients who completed an 8-week 
course in Mindfulness-Based Stress Reduction (MBSR). A similar trend was noted in the application of 
mindfulness-based cognitive therapy for a group of cancer survivors; 30% of the treatment group showed 
clinical improvement in levels of fatigue versus just 4% of the control group. Furthermore, the treatment 
effect was still present at a six month follow-up (van der Lee & Garssen, 2010). The effect of mindfulness 
training on patients suffering from Multiple Sclerosis has also been investigated; levels of fatigue, 
depression and quality of life were all shown to improve following an 8 week mindfulness training course 
(Grossman et al. 2010). “Distressed individuals” (as measured by self-report answers to the question “how 
often do you feel distressed?”) have also been shown to benefit from mindfulness-based interventions, as an 
eight week course in MBSR resulted in statistically significant decreases in fatigue and perceived stress 
accompanied by increases in quality of life, positive affect and mindfulness for such a population (Nyklíček 
& Kuijpers, 2008).
        New research suggests that meditation techniques suppress the hypothalamic-pituitary-adrenal axis and 
the sympathetic nervous system, which usually up regulate cortisol and catecholamines, perpetuating the 
body’s stress response. Studies also suggest that meditation can boost the immune system by increasing 
levels of IgA antibodies and natural killer immune cells while decreasing markers such as inflammatory 
cytokines and C reactive protein. Furthermore, neuroimaging research demonstrates that mindfulness 
meditation can induce “neuroplastic changes” in several areas of the brain including the anterior cingulate 
cortex, insula, tempro-parietal junction, and fronto-limbic network. These changes are associated with the 
reduction of stress-related symptoms in part through enhanced immune function. (Purdy, 2013)
      Kundalini Yoga incorporates mindfulness practice with a triad of stretching, breathing, and meditation. 
 The KY practice to be used in this study was promulgated and disseminated by one of best known teachers 
of KY in the Western Hemisphere, Guruchan Singh Khalsa. Dr. Alexander who is a certified instructor in 
 this method has had over 500 hours of training in KY. 
      Given the neurological changes and clinical improvements associated with meditation and mindfulness, 
we are hopeful that the proposed study will demonstrate a decrease of fatigue, pain, and other symptoms of 
Post-Treatment Lyme Disease.
     Our goal in this study is to assess the efficacy of meditation and stretching in patients with chronic Lyme 
disease symptoms. Positive results from this study could provide patients with an alternative therapeutic 
modality when standard treatments are no longer working. The three components of treatment consist of a 
weekly group therapy consisting of 10 minutes of muscular relaxation/stretching exercises and a meditation 
period characterized by a directed breathing exercise followed by a guided meditation.    
     In this study, patients are randomly assigned either to 8 weeks of active treatment or an 8 week wait-list. 
  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).  These patients however will be offered the opportunity to 
receive 8 weeks of treatment in the next group that starts after the 8 weeks of waiting has ended.     

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Specific Aims and Hypotheses
Specific Aims and Hypotheses
Primary Study Goals/Aims
1. To assess whether people with PTLDS self-report greater change in core symptom of fatigue and pain, 
and satisfaction with global health after receiving study treatment for 8 weeks than people with PTLDS who 
do not receive such treatment.
Secondary Study Goals/Aims
1. To assess whether people with PTLDS self-report greater change in secondary outcome measures 
(physical & social functioning, multisystemic symptoms, anxiety, depression) after receiving study 
treatment for 8 weeks than people with PTLDS who do not receive such treatment
2. To assess the compliance of patients with weekly group meditation/stretching therapy and (based on self-
report) the daily meditation therapy.
3. To assess at 6 month follow-up whether patients have continued with the medication practice, whether 
gains observed at week 8 have been sustained, and the medical utilization over the prior 3 month period 
compared to the pre-study medical utilization.
 
4. To assess whether the pre-treatment measures of stress, trauma history, illness perception, intolerance of 
uncertainty, and pain catastrophizing are variables that are related to 8 week and 6 month outcome.
 
Our overall hypothesis is that participants in the experimental group who perform meditation and stretching 
exercises daily in addition to educational seminars will improve to a greater extent (measured by self-report 
questionnaires of symptoms, functioning, and health satisfaction at baseline, mid-way and 8 weeks) 
compared to the control group.
Description of Subject Population
Sample #1
Specify subject population
40
Number of completers required to accomplish study aims
34
Projected number of subjects who will be enrolled to obtain required number of completers
40
Age range of subject population
18-65

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Gender, Racial and Ethnic Breakdown
Based on prior studies of individuals with Lyme disease, we anticipate the following gender and 
racial/ethnic group representation
Gender: 60% women, 40% men
Racial/ethnic: 90% Caucasian, 10% other
(The racial/ethnic mix reflects the demographics of heavily Lyme endemic regions which tend to be rural or 
suburban areas as opposed to urban cities)
Description of subject population
40 individuals with previously diagnosed and treated Lyme disease, male and female, all ethnicities, age 18-
65.
Recruitment Procedures
Describe settings where recruitment will occur
1. Notices will be placed on the Columbia Lyme center website, the Holistic Center “The Aquarian Path” 
website, and in Dr. Charles Alexander’s office in Fairfield, CT 
2. Flyers will be posted in public locations in Fairfield, CT (e.g, library, yoga studio)
3. Flyers will posted in the offices of doctors in the region.  
4. As of April 2018, we want to add information regarding this study on the Columbia Recruit Me 
website- https://recruit.cumc.columbia.edu/  
How and by whom will subjects be approached and/or recruited? 
1. Subjects will be recruited by media advertisements (website, newspapers), by Dr. Charles Alexander in 
his clinical practice.
      a.  Prior to posting ads in newspapers and online, the notice will be submitted to the IRB for approval 
      b. Information about the study will be made available to patients by Dr. Charles Alexander and by Dr. 
Brian Fallon in their routine encounter with patients. 
2. Information about the study will be publicized in Fairfield, CT and through newspapers and online 
sources. 
3. Patients will be recruited directly from Dr. Charles Alexander or in response to media advertisements 
(e.g., web, newspapers). 
4. Fliers with a cover letter will be sent to clinicians in the area of the study for referral of patients to the 
Columbia Lyme Service for recruitment.
        a. Prior to sending fliers and cover letters to clinicians, the notice will be submitted to the IRB for 
approval. 
 
How will the study be advertised/publicized? 
1. Information about the study will be publicized in Fairfield, CT and through newspapers and online 
sources. 
2. Patients will be recruited directly from Dr. Charles Alexander or Dr. Brian Fallon in response to media 
advertisements (e.g., web, newspapers). 
3. Fliers with a cover letter about the study will be sent to clinicians with practices in the region of the study 
so that they may distribute it to their patients. 

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4. As of April 2018, we want to add information regarding this study on the Columbia Recruit Me 
website- https://recruit.cumc.columbia.edu/  
Do you have ads/recruitment material requiring review at this time? 
Yes
Does this study involve a clinical trial?
Yes
Please provide the NCT Registration Number
NCT02344537
Concurrent Research Studies
Will subjects in this study participate in or be recruited from other studies? 
No
Inclusion/Exclusion Criteria
Name the subject group/sub sample
Experimental and Treatment as Usual Groups
Create or insert table to describe the inclusion criteria and methods to ascertain them
 
 Criterion                                                   Method of Ascertainment
 History of prior diagnosis of Lyme 
Disease by health care provider at least 6 
months prior to assessment
                                                                      
                                                        
Documentation/records of 
diagnosis made by physician
 Previously treated for Lyme Disease
 Documentation of prior 
treatment for Lyme Disease that 
meets IDSA recommended 
standards for the stage of 
illness; 
 Current symptoms of PTLDS started 
within 6 months after getting Lyme 
disease
 Self-report and review of 
medical records if available
 Current symptoms have persisted for at 
least the last 6 months.
 Self-report and review of 
medical records if available
Between the ages of 18 and 65, male or 
female
Self-report
 English speaking    
Phone screening and self-report

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 Primary complaint of fatigue or pain 
-If fatigue, the severity score on 
the Promis Fatigue measure is 
60 or higher (T-score);
- If pain, the severity score on 
the VAS (0-10) Pain is at least 
4 
 Individuals whose medical and/or 
psychiatric treatment has been stable for 
the prior 8 weeks
 Self-report
 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
 Self-report
 
Create or insert table to describe the exclusion criteria and methods to ascertain them
 Criterion                                                                                          Method of Ascertainment
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)
Self-report and review of medical records 
if available                                                   
                                                                      
                                                                      
            
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)
MINI Mental State Assessment and Self-
Report
 Individuals with severe depression   
Phone interview and a T-score of 70 and 
above PROMIS Depression- Short Form (8 
item version).
 
 Individuals with Physical disability that might make study 
participation difficult 
 
Self-report and review of medical records 
if available
 
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. 
 Phone interview and self-report
 
Unwillingness to complete questionnaires, speak with study 
research assistant, or dedicate twenty minutes daily to 
meditation and stretching 
 Self-report

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Suicidal attempts within the last 6 months or current suicidal 
thoughts
 Phone interview and the "suicidality item" 
on the Beck Depression Inventory is a 
score of "2 or more"
 
Individuals unwilling to delay starting optional treatment for 
Lyme disease for the duration of the study 
 Self-report
 Individuals with a prior lifetime practice of at least one 
month of daily practice of Kundalini yoga or those who 
currently practice daily meditation or yoga
 Self-report
 
 
Waiver of Consent/Authorization
Indicate if you are requesting any of the following consent waivers
Waiver of consent for use of records that include protected health information (a HIPAA waiver of 
Authorization) 
No
Waiver or alteration of consent
Yes
Waiver of documentation of consent 
No
Waiver of parental consent 
No
Consent Procedures
Is eligibility screening for this study conducted under a different IRB protocol?
No
Describe procedures used to obtain consent during the screening process 
1. Patients will be screened over the telephone by the study research assistant (RA) for possible enrollment.
2. If patient’s self-report suggests eligibility, a copy of the consent form will be sent to the patient for 
review.
3. The patient will be asked to fax records of treatment history and prior blood tests for Lyme. The RA will 
then review Lyme disease/treatment documents.
Describe Study Consent Procedures
1. After patients are screened and records are reviewed to confirm the inclusion/exclusion criteria are met, 
patients will be invited to attend an introductory session with Dr. Charles Alexander. At this introductory 
meeting, the consent form will be reviewed with the participant by Dr. Charles Alexander including the 
study purpose, alternatives, risks and benefits. After the participant signs consent, Dr. Charles Alexander 

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will mail, fax, or scan/efax the form back to us; we do have a HIPAA secure efax.  We will then sign the 
consent on our end and file this in the participant’s chart. Once signed consent is obtained, the participant 
will be randomly assigned to either wait-list control or experimental group.
 
2. Should a patient articulate suicidal ideation voluntarily or select a score on item 9 of 2 or more on the 
Beck Depression Inventory, then the study RA will notify the study principal investigator in order for him to 
follow-up with the patient.
Indicate which of the following are employed as a part of screening or main study consent procedures
   Consent Form
Justification for Waiver or Alteration of Consent
Waiver of consent is requested for the following
Partial Waiver for telephone screens.
Explain why your research can not be practicably carried out without the waiver or alteration
The initial phone screen is done in order to establish the participants Lyme history. It is difficult to get 
participants in without initial contact over the phone and without having some background of their Lyme 
history.
Describe whether and how subjects will be provided with additional pertinent information after participation
Participants will receive a copy if the consent form and the notices of privacy practice form for their
records.
Persons designated to discuss and document consent
Select the names of persons designated to obtain consent/assent
Doshi, Shreya, MA
Fallon, Brian, MD
Type in the name(s) not found in the above list
Dr. Charles Alexander, MD
 
Study Procedures
Describe the procedures required for this study
Recruitment
1. Interested participants will respond to flyer advertisements or hear about this meditation study in the 
context of talks given by Dr. Fallon or Dr. Alexander.   Interested individuals will be guided to contact the 
screening study coordinator directly to be evaluated further and to learn more about the study.  Dr. 

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Alexander will not actively recruit study participants directly from his own private practice, although a flyer 
will be available in his office. Interested individuals from his practice would similarly be told to contact the 
study coordinator to learn more. 
Screening
2a. Participants will be screened over the phone following a screening questionnaire to ensure they meet the 
inclusion criteria and do not have any exclusion conditions. A brief medical and psychiatric history will be 
obtained.  A question has been added to the screening questionnaire that confirm that if the potential study 
participant is a current patient of Dr. Alexander that he has not previously discussed the study with him/her. 
2b. If information obtained during the telephone screen indicates that the patient is or may be suicidal, the 
principal investigator (Dr. Fallon) will be notified immediately.  Dr. Fallon will then talk with the patient to 
assess further; the subsequent action would be according to risk: i)  providing a referral to a psychiatrist or 
mental health clinic in the patient's geographic area if the risk is deemed low; or ii) if the risk is deemed 
moderate or high, advising the patient to come directly to the NYSPI for an in-person evaluation by Dr. 
Fallon or go to the local emergency room for immediate in-person evaluation.   
 
Consent Procedures
3. Once potentially eligible participants have been screened and eligibility confirmed, a member of our 
research team will send them a consent form either electronically or by mail. The consent form will be 
reviewed with the participant over the telephone by a research assistant, including the study purpose, risks 
and benefits. The subject will then be assigned an introductory meeting date. At the meeting, Dr. Charles 
Alexander will again review the consent form and both Dr. Alexander and the subject will sign consent in 
person. Dr. Charles Alexander will then fax or efax the signed consent form back to us (& keep the original 
in a locked file in his office for our later pick-up).  Once signed consent is obtained by us from Dr. 
Alexander and once patients have returned the baseline self-assessment forms to us, the participant will be 
randomly assigned to either the control or experimental group by us.
Study Procedures
 
4. Participants will be randomly assigned to the control or experimental group. 
     a. Controls will be on a wait-list in which they will complete self-report questionnaires at baseline, 4 
weeks and eight weeks.
    b. The experimental group will be told that a start-date will be provided once a certain number of people 
have been found eligible to start. Groups of 6-8 participants will run concurrently. 
 
5. After consent is signed, for a baseline evaluation, self-report questionnaires will be given to the patient by 
Dr. Alexander or sent to the participant electronically. The self-report questionnaires will consist of 
questions regarding the participant’s current clinical status. 
 
6. The experimental group will attend an introductory meeting to be taught the meditation and stretching 
protocol. It will be a guided meditation in which Dr. Alexander will speak over a foundational sound for 
about eleven minutes. The narrative will provide a focus for the mind to induce a focused awareness. The 
spoken narrative is about focusing, expanding and refining the participants’ perception. Each participant in 
the experimental group will receive a copy of the guided meditation to listen to every day. The stretching 

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protocol will consist of simple postures and stretches that will last for about 10 minutes. Participants will 
receive a handout of the different postures that are to be completed each day along with the meditation.
 
7, The first part of the guided meditation will last about 8 minutes. It is a directed breath. Sitting 
comfortably with a straight spine in a chair or on the floor as desired, the subject is instructed to perform a 
short repetitive breath named Breath of Fire. Breath of Fire is characterized as an active exhale, a pulse of 
the abdomen in towards the spine, which forces air from the lungs. This is than followed by a relaxation of 
the abdominal muscles and diaphragm. As the abdomen and diaphragm relax air enters back into the lungs 
only to be exhaled again by the pulse of the abdominal muscles. This progresses at an approximate rate of 
one breath per second but when done correctly it does not lead to hyperventilation and, in fact, it can be 
preformed for extended periods of time. In this study, the breath is performed with the thumb tip touching 
first the tip of the index finger while the hands are rotating at the wrists. The rotation is a small movement 
such that the right hand is rotating clockwise while the left rotates counter clockwise. This causes the hands 
to approach each other at the bottom of the rotation and to depart from each other at the top of the rotation. 
If there is too much pain in the wrist joints to do this comfortably, the hand rotation can be done as a 
visualization. After one and a half minutes, while continuing the hand rotation, the thumb is switched so as 
to touch the tip of the middle finger for a minute and a half than, sequentially, the other fingers until all have 
spent an equal amount of time touching the thumb tip. When all this is completed, the hands are cupped and 
brought together such that the finger tips of one hand are in contact with the same fingertip of the opposite 
hand. After one minute the two cupped hands are separated so as to create a space of about 6 inches between 
the tips of the fingers. After one minute more the subjects move on to the guided meditation.
The second part, a Guided Meditation, will last 11 minutes. It is composed of words spoken over a musical 
background. In this meditation the subjects are guided to picture a healing force or light, a positive energy 
field, circulating around and within and through themselves. When this force comes in contact with areas 
that are troubled or painful, subjects are instructed to visualize the distress as being transformed such that 
healing takes place.
 
8. Participants in the experimental group will be asked to maintain a meditation log throughout the 8 weeks. 
They will be asked to record the number of minutes of meditation and stretching as well as any discomfort 
they experienced.
 
9. Weekly sessions will be offered at a time that is most suitable for the group of 6-8 members.  At each 
session. the experimental group will practice meditation and stretching as a group as well as have the 
opportunity to ask any questions about their daily practice. 
 
10. When control participants have completed their eight week wait time and their final self-report 
questionnaires and they wish to learn the meditation approach provided by this study, they will be offered an 
8 week no-cost treatment by Dr. Alexander as part of a separate treatment group of “treatment as usual” 
randomized subjects.
 
11. All participants will be evaluated by self-report questionnaire and telephone follow-up by our research 
coordinator 6-months after starting the meditation therapy or the wait-list assignment. 
 

Protocol Summary Form
6927
Fallon, Brian
Page 15 of 19
12. For clinical emergencies, Dr. Alexander and Dr. Fallon will provide their cell phone numbers to study 
participants for use as needed.  
 
 
You can upload charts or diagrams if any
Criteria for Early Discontinuation  
Criteria for Early Discontinuation
Participants will be dropped from the study if they meet either of the following criteria:
        a) suicidal ideation emerges during the study as self-reported by the individual or as assessed by a BDI 
Item-9 score of 2 or more at week 4;
  or 
        b) depression worsens significantly - this will be operationalized as: 
                  i. BDI score worsening by more than 5 points from the prior assessment;
          and ii. the score falls into the severe range (value 29-63) on the BDI-II at week 4 and remains elevated 
at a repeat assessment at week 5. 
 
Participants who meet either of the above will meet with Dr. Alexander who will evaluate the individual 
psychiatrically and refer him/her for appropriate care.   That individual will no longer be in the study.  
Assessment Instruments
Create a table or give a brief description of the instruments that will be used for assessment
 Primary Measures
Measure Title 
 # of 
items
 Baseline 
 
 Week
4
 Week
8
 6Month
s
 Promis 43 Panel- Pain 
Interference
 6
 x
 x
 x
 x
 Brief Pain Inventory VAS  
 9
 x
 x
 x
 x
 Promis Fatigue 1.0 
 7   
 x
 x
 x
 x
 Global Health Satisfaction
 9
 x
 x
 x
 x
 
Secondary Measures
Measure Title
 # of 
Items
 Baselin
e
Week4  Week
8
6months
 
 Mindful Attention Scale
15
x
x
 

Protocol Summary Form
6927
Fallon, Brian
Page 16 of 19
 Multisystem Symptom 
Questionnaire   
 34       x
 x
 x
 x
 Promis 43 Sleep, Depression, 
Anxiety,Physical Function
 24
 x
 x
 x
 x
 Promis Social Satisfaction
 8
 x
 x
 x
 x
 Beck Depression Inventory
 21
 x
 x
 x
 x
 Daily Meditation Record
x
x
x
 Intolerance of Uncertainty
 7
 x
 
 
 
 Applied Cognition (NIH toolbox) 
 
 8      
 x
 x
 x
 x
 Pain Catastrophizing      
 6
 x
 
 
 
 Life Events History Scale
 16
 x
 
 
 
 Perceived Stress Scale
 4
 x
 
 
 
 CD-RISC
 2
 x
 
 
 
 Brief Illness Perception
 8
 x
 x
 x
 
 Whiteley Index 
 7
 x
 x
 x
 x
 Medical Utilization Questionnaire  6
 x
 
 
 x
Please attach copies, unless standard instruments are used
Research Related Delay to Treatment
Will research procedures result in a delay to treatment?
Yes
Maximum duration of delay to any treatment 
Participants randomized to “treatment as usual” will have to wait a minimum of 8 weeks to start active 
treatment with meditation. These individuals will have fulfilled their agreement with our study and would 
no longer be asked to avoid starting treatments. Should they wish to receive the 4 weeks of offered group 
meditation therapy, the next “TAU” meditation group would be expected to start within 4-6 weeks of their 
study completion. 
Participants randomized to “meditation/stretching” may have to wait 4-8 weeks until a group of 6-7 eligible 
participants are identified who have been randomized to meditation. Groups of 6-7 eligible participants will 
run concurrently to minimize the wait time for participants. 
All participants in this study will be able to continue during the study with whatever treatment they had been 
receiving prior to the start of this study. They will only be asked not to start new treatments, unless it is 
medically or psychiatrically recommended by their doctor. If they need to start a new treatment during the 
study, we will ask them to complete self-report questionnaires prior to starting the new treatment and then 
notify Dr. Charles Alexander and Rachel Goldman so we can make note of it in their research record. 
Maximum duration of delay to standard care or treatment of known efficacy
8 weeks

Protocol Summary Form
6927
Fallon, Brian
Page 17 of 19
Treatment to be provided at the end of the study
No
Clinical Treatment Alternatives
Clinical treatment alternatives
Individuals do not have to participate in this study in order to obtain guidance in meditation or yoga 
stretching. Both therapeutic modalities are available elsewhere. Individuals who wish to receive private 
treatment will be advised to consult with practitioners in their area.  
Risks/Discomforts/Inconveniences 
Risks that could be encountered during the study period
1. Quiet Meditation can sometimes lead to distress among individuals with a prior trauma history as they 
may re-visualize or remember the trauma during the quiet meditation.
2.The self-report questionnaires may lead to psychological distress among some individuals.
3. Stretching or postures may lead to discomfort. 
4. Individuals are asked to not start new treatments during the course of this study.   For patients who may 
wish to start an optional treatment, the 8-12 week delay in starting a new treatment may result in delay in 
receiving a potentially  beneficial optional treatment. 
Describe procedures for minimizing risks
1. Patients can stop the self-report questionnaires, postures or meditation at any point or if distress is 
excessive
2. Participants who have indicated suicidal thoughts on item 9 of the BDI (score of 2 or more) will be 
evaluated further and referred to a local mental health provider as needed
3. Dr. Charles Alexander and Dr. Brian Fallon will be reachable by phone in the case of an emergency 
throughout the study
4. If discomfort arises during stretching or postures, patients will be told they can stop at any point
5. If a treatment is recommended by a physician as medically necessary, then that treatment is allowed - the 
participant merely needs to notify us of this change. 
Methods to Protect Confidentiality
Describe methods to protect confidentiality
All of the patients' paper-based self-report questionnaires and research data will be stored in locked filing 
cabinets and will be kept confidential to the extent permitted by law. Research binders will be available only 
to research staff and Federal, State and Institutional personnel as part of routine audits. There are legal 
advocacy organizations that have the authority under State law to access otherwise confidential subject 

Protocol Summary Form
6927
Fallon, Brian
Page 18 of 19
records, but they cannot re-disclose this information without the patient’s consent. Any research data 
transmitted or stored electronically will use a subject ID number, not the patient’s name.
Self-report questionnaires and research data that are collected electronically will be collected via 
REDCap (Research Electronic Data Capture), hosted at Columbia University.  REDCap is a secure 
web application for building and managing online surveys and databases that complies with HIPAA 
requirements for a secure database.  
Will the study be conducted under a certificate of confidentiality?
No
Direct Benefits to Subjects  
Direct Benefits to Subjects
This study may or may not directly benefit participants, however participation will contribute to the 
evaluation of a potentially beneficial treatment for the symptoms that persist among many patients with a 
history of Lyme disease. It is hoped that the knowledge gained in this study will be of benefit to patients 
suffering from Lyme disease in the future. 
Compensation and/or Reimbursement 
Will compensation or reimbursement for expenses be offered to subjects?
No
References
References
Olino, T. M., Yu, L., McMakin, D. L., Forbes, E. E., Seeley, J. R., Lewinsohn, P. M., & Pilkonis, P. A. 
(2013). Comparisons Across Depression Assessment Instruments in Adolescence and Young Adulthood: An 
Item Response Theory Study Using Two Linking Methods. Journal of abnormal child psychology,41(8), 
1267-1277.
 
Carlson L., Garland, S. Impact of Mindfulness-Based Stress Reduction (MBSR) on sleep, mood, stress and 
fatigue symptoms in cancer outpatients. International Journal of Behavioral Medicine. 2005; 12(4):278-285 
 
Collins C. Yoga: Intuition, preventive medicine, and treatment. J Obstet Gynecol Neonatal Nurs. 1998; 
27:563-8
 
Grossman et al. MS quality of life, depression, and fatigue improve after mindfulness training. Neurology. 
2010; 75(13):1141-1149
 

Protocol Summary Form
6927
Fallon, Brian
Page 19 of 19
Khalsa MK, Greiner-Feris JM, Hofmann SG, Khalsa SBS. Yoga-enhanced CBT for Anxiety Management: a 
pilot study. Clin Psychology and Psychotherapy 2014 
 
Mist SD, Firestone KA, Jones KD. Complementary and alternative exercise for fibromyalgia: a meta-
analysis. J Pain Research 2013; 6: 247-260. 
 
Nyklíček, I., Kuijpers, F. Effects of Mindfulness-Based Stress Reduction intervention on psychological 
well-being and quality of life: is increased mindfulness indeed the mechanism? Annals of Behavioral 
Medicine. 2008; 35(3):331-340 
 
Purdy, J., Chronic Physical Illness: A Psychophysiological Approach for Chronic Physical Illness. Yale 
Journal Of Biology and Medicine. 2013; 86 (1): 15-28 
 
Ross A., Thompson S. The health benefits of yoga and exercise; a review of comparison studies. J Altern 
Complement Med. 2010; 16(1):3-12)
 
Shannahoff-Khalsa DS. An introduction to Kundalini yoga meditation techniques that are specific for the 
treatment of psychiatric disorders. J Alt Complementary Medicine 10 (1), 2004; pp 91-101. 
 
Shannahoff-Khalsa DS. Yogic meditation techniques are effective for the treatment of OCD. In: Hollander 
E, Stein D, eds.  OCD: etiology, diagnosis, and treatment. NY: Marcel Dekker, Inc., 1997; 283-329. 
Shannahoff-Khalsa DS, Ray LE, Levine S, Gallen CC, Schwartz BJ, Sidorowich JJ. Randomized controlled 
trial of yogic meditation techniques for patients with OCD. CNS Spectrums 1999; 4 (12): 34-47 
 
van der Lee, L., Garssen, B. Mindfulness-based cognitive therapy reduces chronic cancer-related fatigue: a 
treatment study. Psycho-Oncology. 2010; 21(3):264-272
Uploads
Upload copy(ies) of unbolded Consent Form(s)
Upload copy(ies) of bolded Consent Form(s)
Upload copy(ies) of recruitment materials/ads to be reviewed
Upload copy(ies) of the HIPAA form
HIPPA_6927_SD_10_13_2015.pdf
Waiver_Meditation_Study_10212016.pdf
Upload any additional documents that may be related to this study

Form #PP2: HIPAA Authorization for Research 4.14.14 
New York State Psychiatric Institute (NYSPI) 
Authorization to Use or Disclose Health Information during a Research Study 
Protocol Number: 
Principal Investigator: 
Name of Study: 
Before researchers can use or share any identifiable health information (“Health Information”) about you as part of the 
above study (the “Research”), the New York State Psychiatric Institute (NYSPI) is required to obtain your authorization. You agree 
to allow the following individuals and entities to use and disclose Health Information about you as described below: 
•
New York State Psychiatric Institute (NYSPI), your doctors and other health care providers, if any, and
•
The Principal Investigator and his/her staff (together “Researchers”).   Researchers may include staff of NYSPI, the New York
State Office of Mental Health (OMH), Research Foundation for Mental Hygiene, Inc. (RFMH), and Columbia University (CU),
provided such staff is a part of the study, and
•
Providers of services for the Research at CU, NYSPI and/or RFMH, such as MRI or PET, or  Central Reference Laboratories
(NKI), if indicated in the consent form.
1.
The Health Information that may be used and/or disclosed for this Research includes:
All information collected during the Research as told to you in the Informed Consent Form.   
Health Information in your clinical research record which includes the results of physical exams, medical and 
psychiatric history, laboratory or diagnostic tests, or Health Information relating to a particular condition that is related  to 
the Research. 
Additional information may include: 
2.
The Health Information listed above may be disclosed to:
Researchers and their staff at the following organizations involved with this Research: 
The Sponsor of the Research, 
and its agents and contractors (together, “Sponsor”); and  
Representatives of regulatory and government agencies, institutional review boards, representatives of the Researchers 
and their institutions to the level needed to carry out their responsibilities related to the conduct of the research.   
Private laboratories and other persons and organizations that analyze your health information in connection with 
this study 
Other (family members or significant others, study buddies, outside agencies etc.) Specify: 
3.
By giving permission to release your Health Information as described above, you understand that your Health
Information may be disclosed to individuals or entities which are not required to comply with the federal and state privacy laws
which govern the use and disclosure of personal Health Information by NYSPI.   This means that once your Health

Lyme and Tick-borne Diseases Research Center at Columbia & Center for Biobehavioral Medicine at NYSPI



Meditation and Stretching for Post Treatment Lyme Disease Syndrome
Brian Fallon, MD
6927

Form #PP2: HIPAA Authorization for Research 4.1.14 
Information has been disclosed to a third party which does not have to follow these laws (e.g., a drug company or the Sponsor 
of the Research), it may no longer be protected under the HIPAA or NYS Mental Hygiene Law requirements but is subject to the 
terms of the consent form and may be subject to other state or federal privacy laws or regulations.  
4.
Please note that:
•
You do not have to sign this Authorization form, but if you do not, you may not be able to participate in the study or
receive study related care.  You may change your mind at any time and for any reason. If you do so, you may no
longer be allowed to participate in the study.  If you withdraw this Authorization the research staff and the Sponsor, if this
is sponsored research, may still use or disclose Health Information containing identifying information they already have
collected about you as needed to maintain the reliability of the research.  Any request to withdraw this Authorization
must be made in writing to (enter name and contact information below):
•
While the Research is going on, you may not be allowed to review the Health Information in your clinical research
record that has been created or collected by NYSPI.   When this research has been completed you may be allowed to see
this information.  If it is needed for your care, your Health Information will be given to you or your Doctor.
5.
This Authorization does not have an end date.
6.
You will be given a copy of this form after you have signed it.
I agree to the use and disclosure of Health Information about me as described above: 
__________________________________________                _____________________ 
Signature of Participant/ Legal Representative    
Date 
______________________________________ 
Printed Name of Participant 
______________________________________ 
Relationship of Legal Representative to Participant (if applicable) 
We also ask you or your legal representative to initial the statements below: 
I have received a copy of the NYSPI/OMH Notice of Privacy Practices. 
Brian A. Fallon, MD, Columbia University Medical Center, Lyme Center, 1051 Riverside Drive, Unit 69, 
NYC, NY 10032

 
New York State Psychiatric Institute Institutional Review Board 
Request for HIPAA Waiver of Authorization and/or Waiver of 
Consent 
 
 
Use this form if you are requesting  to waive or alter  some or all of the 
elements of consent and/or of HIPAA authorization requirements. 
 
IRB Protocol Number: 7537                 Name of Principal Investigator: Brian Fallon, MD 
Title of Study: Evaluation of patients with Lyme Disease and Healthy Controls – An 
Umbrella Screening Protocol for Individuals Interested in Lyme Research 
 
Please indicate and explain nature of request below: 
 
Partial Waiver for telephone screens. 
Partial Waiver for internet survey research. 
Full Waiver for the purpose of accessing an existing database or records (paper 
or electronic) to identify potential subject or to conduct above research. 
 
 
Describe the identifiable information that you will be collecting or 
accessing under this waiver (Be specific to allow the IRB to determine whether 
the information includes any of the 18 HIPAA identifiers or any other method of 
identifying the individuals): Name, Telephone Number, Email, Lyme Medical 
Records- especially, the following- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The study, or phase of the study for which the waiver is being sought, should 
present no more than minimal risk to the subject, including risk to their 
confidentiality. Please explain how your study, or the phase of the study for 
which the waiver is being sought, meets the following criteria: 
 
 
 
1.  Explain why the waiver or alteration will not adversely affect the rights 
and welfare of the subjects. The only possible risk of doing the phone screen is 
that the participants may find some of the screening questions distressing because 

 
it asks about their medical history. If this happens, they can choose not to answer 
specific questions. 
 
2.  Explain why is it not practical to obtain consent and/or authorization from  
      subjects? The initial phone screen is done in order to get the participants in for a 
       more detailed evaluation under the Meditation and Yoga for Patients with Post-   
       treatment Lyme protocol. It is difficult to get participants in without initial contact    
       over the phone and without having some background of their Lyme history. 
 
 
 
 
 
3.  Can the research practicably be conducted without access to, and use of, the 
individually identifiable information? If not, why? No. It is imperative that we 
collect certain PHI and ask participants to send us Medical Records for us to review 
since it is the only way we can ascertain if they have Lyme disease. Also, name, 
telephone number and email address are needed because we need to get in touch 
with them. 
 
4.  Indicate how you plan to protect the identifiers from improper use and  
disclosure.  
Check all that apply: 
Electronic safeguards where only study staff has access and the database 
meets all security requirements as outlined in the NYSPI Security Plan (e.g. 
password protection, data encryption, firewall, no outside transmission of data, 
restricted access etc). 
Physical safeguards where only study staff has access to areas with study 
information and NYSPI recommendations for physical security are in place 
(locked cabinets, locked filing room, restricted access etc). 
No identifiers, links or codes will be retained that permit data to be identified. 
Other: 
 
5.  Describe your plan to destroy the identifiers at the earliest opportunity: 
Identifiers will be destroyed if the patient does not meet criteria for admission 
to the study 
Identifiers will be retained until potential subjects sign consent and 
authorization and complete the study. Destruction of all identifiers will be 
consistent with federal, state and Institute policies, and or other contractual 
agreements. 
N/A as I will not record identifiers or create links or codes to connect the data 
 
6.  Where applicable:   Describe how subjects will be provided with 
additional pertinent information after participation. 
       Participants will receive a copy if the consent form and the notices of privacy 
     practice form for their records. 
 
By submitting this application you are certifying that the protected health 
information or other identifiable information will not be reused or 
disclosed except as required by law, for authorized oversight of the 
research, or for other research that has been reviewed and approved by the 
IRB with specific approval regarding access to this protected health 
information. 
 
Agree            Do not agree 
 

 
 
 
FOR THOSE REQUESTING ACCESS TO MEDICAL RECORDS MAINTAINED AT NYSPI 
Please also complete the following to describe selection criteria for your request: 
Selection Criteria for records required (e.g. diagnosis, age, date of admission) 
Dates of required records: from         /        /         through         /        / 
 
Anticipated sources of information (check all that apply) 
Paper medical records,     Owner 
 
OMH EMR and/or DUKE EMR 
 
Other (describe) 
Number of records needed:  Number   
 
> 50                      < 50
 
 
 
 
 
 
 
 
 
NYSPI Form PP#10.15