Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study

• ClinicalTrials.gov Identifier: NCT04349605
• Recruitment Status: Not yet recruiting
• First Posted: April 16, 2020
• Last Update Posted: April 16, 2020
• Sponsor: Research Foundation for Mental Hygiene, Inc.
• Information provided by (Responsible Party): Brian A Fallon, Research Foundation for Mental Hygiene, Inc.

Study Description

Brief Summary:

This randomized, controlled study examines whether a daily practice over 8 weeks of Kundalini Yoga or Meditation can help to reduce pain and/or fatigue among patients with symptoms that persist despite prior antibiotic treatment.

Condition or disease	Intervention/treatment	Phase
Post-Treatment Lyme Disease	Behavioral: Meditation; Behavioral: Kundalini Yoga	Phase 2

Detailed Description:

Research reports indicate that approximately 5-20% of patients treated for Lyme disease with the IDSA-recommended 2-4 week course of antibiotics will continue to have symptoms of fatigue, pain, cognitive problems, and/or joint and muscle aches despite prior antibiotic treatment. The symptoms can last months to years after treatment. The medical community officially calls this condition "Post-treatment Lyme disease Syndrome" (PTLDS) when patients meet strict inclusion and exclusion criteria. The patient community commonly calls this condition "chronic Lyme disease" (CLD). Although there is debate about the exact cause of these symptoms, there is widespread agreement that this is a growing public health problem as an increasing number of patients are suffering with symptoms of pain, fatigue, and cognitive problems ("brain fog") despite having received not just the standard treatment courses but even after many courses of antibiotics and other interventions.

While antibiotic therapy is the key to the treatment of active infection, other approaches are needed for those patients whose symptoms persist despite the best antibiotic treatment efforts. Alternative treatments that can assuage fatigue, muscle and joint pains, and improve cognitive function are urgently needed. Recent studies indicate that mind body practices (e.g., meditation; Kundalini Yoga) can be helpful strategy in reducing chronic symptoms, such as pain, fatigue, and poor mental focus. This study examines the efficacy of two mind-body therapies among patients with PTLDS and CLD: a) the breathing, meditation, and stretching techniques common to Kundalini Yoga practice; and b) meditation and breathing techniques common to Western meditation practices. We plan to assess the degree to which these practices can reduce the chronic symptoms compared to a wait-list control group. Because fatigue and multi-system symptoms are so common among patients with PTLDS or CLD, these will be the primary focus of this study. Primary outcome will be improvement in these self-reported core symptoms and in self-reported quality of life. Secondary outcomes will assess cognitive complaints, pain, physical and mental functioning, somatic symptoms, and psychopathology.

This will be an on-line study. During this study, patients will be screened through an on-line process, review consent, and complete self-report questionnaires. 225 patients will be enrolled. Of these, 75 will be randomly assigned to Kundalini yoga and meditation therapy, 75 will be assigned to a meditation & mindfulness App, and 75 will be assigned to a "treatment as usual" wait-list. Assessments will be conducted weekly for 8 weeks; there will also be a 6 month follow-up by questionnaire. Study participants randomized to the "treatment as usual" control group will be offered the option of receiving guided on-line meditation at the end of the 8 weeks.

Should this study find evidence suggesting that either meditation therapy and/or Kundalini Yoga are helpful in reducing the symptoms that persist after Lyme disease treatment, this would be a valuable and welcome research finding.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants are randomly assigned to one of the three treatment arms of the study - Kundalini Yoga, Meditation, or Treatment as usual.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Meditation and Yoga for Patients With Persistent Symptoms After Lyme Disease
• Estimated Study Start Date: June 1, 2020
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: March 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Meditation; This is a daily 15 minute meditation with guided breathing. Accessible through an app.	Behavioral: Meditation; Meditation involves guided breathing and mindfulness training.
Experimental: Kundalini Yoga; This is a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.	Behavioral: Kundalini Yoga; Kundalini Yoga involves stretching, guided breathing and meditation
No Intervention: Treatment as Usual; This group will serve as the comparison to assess the efficacy of the active treatments in that no study treatment will be provided. The participants will be asked to not start new treatments during the 8 weeks of the study.

Outcome Measures

Primary Outcome Measures :

1. Fatigue Severity Scale [ Time Frame: Up to 24 weeks ]
   A Fatigue impact measure
2. General Symptom Questionnaire-30 [ Time Frame: Up to 24 weeks ]
   A self-report measure of multi-system symptom burden
3. Quality of Life Experience Scale [ Time Frame: Up to 24 weeks ]
   A measure of qualify of life

Secondary Outcome Measures :

1. Pain Visual Analog Scale [ Time Frame: Up to 24 weeks ]
   A self-report measure of pain severity
2. Applied Cognition scale [ Time Frame: Up to 24 weeks ]
   A self-report measure of cognitive function
3. PROMIS-29 [ Time Frame: Up to 24 weeks ]
   A self-report measure of seven symptom and functional domains
4. SF-12 [ Time Frame: Up to 24 weeks ]
   A self-report measure of physical and mental functioning

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Continued Lyme disease-related symptoms despite prior antibiotic treatment
2. Current symptoms of either fatigue or pain that is moderate in severity
3. Treatment history over the prior 8 weeks: Either no treatment or it's been stable
4. Willingness to not start a new medical or psychiatric treatment during the 8 study weeks
5. Access to a smart phone
6. Age 18-70 and able to read and understand English
7. Lives in the United States

Exclusion Criteria:

1. Current severe depression, Substance abuse in the last 6 months, pain disorder treated with an opiate-based medication, or current or past episodes of Psychosis or Bipolar disorder.
2. Individuals with physical disability that might make study participation difficult.
3. 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
4. Unwillingness to complete questionnaires on-line or dedicate thirty minutes daily to meditation and/or stretching
5. Unwillingness to continue in the study for 8 weeks by completing self-report evaluations if randomly assigned to the wait-list rather than to Kundalini Yoga or Meditation.
6. Individuals unwilling to delay starting any new Mind-body practice (e.g., meditation , Yoga) until after the 8 weeks of the study have been completed.
7. Individuals with a current daily practice of Mindfulness-based stress reduction or those who currently have a daily practice of meditation or yoga
8. Individuals unwilling to provide records of prior diagnosis and treatment for Lyme disease

9. Individuals unwilling to accept push notifications to their smartphone or computer

   -

Contacts and Locations

Contacts

Contact: Ellen Brown, BA; 646-774-8091; eb3048@cumc.columbia.edu

Contact: Brian A Fallon, MD; baf1@cumc.columbia.edu

Sponsors and Collaborators

Research Foundation for Mental Hygiene, Inc.

Investigators

• Principal Investigator: Brian A Fallon, MD; Columbia University Irving Medical Center

More Information

Publications:

Carlson LE, Garland SN. Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Int J Behav Med. 2005;12(4):278-85.

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.

Khalsa MK, Greiner-Ferris JM, Hofmann SG, Khalsa SB. Yoga-enhanced cognitive behavioural therapy (Y-CBT) for anxiety management: a pilot study. Clin Psychol Psychother. 2015 Jul-Aug;22(4):364-71. doi: 10.1002/cpp.1902. Epub 2014 May 7.

Shannahoff-Khalsa D, Fernandes RY, Pereira CAB, March JS, Leckman JF, Golshan S, Vieira MSR, Polanczyk GV, Miguel EC, Shavitt RG. Kundalini Yoga Meditation Versus the Relaxation Response Meditation for Treating Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Front Psychiatry. 2019 Nov 11;10:793. doi: 10.3389/fpsyt.2019.00793. eCollection 2019.

Wang YY, Li XH, Zheng W, Xu ZY, Ng CH, Ungvari GS, Yuan Z, Xiang YT. Mindfulness-based interventions for major depressive disorder: A comprehensive meta-analysis of randomized controlled trials. J Affect Disord. 2018 Mar 15;229:429-436. doi: 10.1016/j.jad.2017.12.093. Epub 2018 Jan 3.

• Responsible Party: Brian A Fallon, Professor of Psychiatry, Research Foundation for Mental Hygiene, Inc.
• ClinicalTrials.gov Identifier: NCT04349605
• Other Study ID Numbers: 7613
• First Posted: April 16, 2020
• Last Update Posted: April 16, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian A Fallon, Research Foundation for Mental Hygiene, Inc.:

Lyme disease; Kundalini Yoga; Meditation; Chronic Lyme Disease

Additional relevant MeSH terms:

Lyme Disease; Post-Lyme Disease Syndrome; Borrelia Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Tick-Borne Diseases; Spirochaetales Infections