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

NCT04349605 | Withdrawn

• 1 other identifier: 7613
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-Treatment Lyme Disease

Keywords

Lyme disease; Kundalini Yoga; Meditation; Chronic Lyme Disease

Outcome Measures

Primary Outcomes (3)

• Fatigue Severity Scale

  A Fatigue impact measure

  Up to 24 weeks

• General Symptom Questionnaire-30

  A self-report measure of multi-system symptom burden

  Up to 24 weeks

• Quality of Life Experience Scale

  A measure of qualify of life

  Up to 24 weeks

Secondary Outcomes (4)

• Pain Visual Analog Scale

  Up to 24 weeks

• Applied Cognition scale

  Up to 24 weeks

• PROMIS-29

  Up to 24 weeks

• SF-12

  Up to 24 weeks

Study Arms (3)

Meditation

EXPERIMENTAL

This is a daily 15 minute meditation with guided breathing. Accessible through an app.

Behavioral: Meditation

Kundalini Yoga

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

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.

Interventions

Meditation BEHAVIORAL

Meditation involves guided breathing and mindfulness training.

Meditation

Kundalini Yoga BEHAVIORAL

Kundalini Yoga involves stretching, guided breathing and meditation

Kundalini Yoga

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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 on-line or dedicate thirty minutes daily to meditation and/or stretching
• 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.
• 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.
• Individuals with a current daily practice of Mindfulness-based stress reduction or those who currently have a daily practice of meditation or yoga
• Individuals unwilling to provide records of prior diagnosis and treatment for Lyme disease
• Individuals unwilling to accept push notifications to their smartphone or computer

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

Related Publications (5)

• 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.

  PMID: 16262547 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.

  PMID: 20876468 BACKGROUND

• 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.

  PMID: 24804619 BACKGROUND

• 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.

  PMID: 31780963 BACKGROUND

• 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.

  PMID: 29331704 BACKGROUND

MeSH Terms

Conditions

Post-Lyme Disease Syndrome; Lyme Disease

Interventions

Meditation

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Brian A Fallon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: Participants are randomly assigned to one of the three treatment arms of the study - Kundalini Yoga, Meditation, or Treatment as usual.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: June 20, 2021
• Primary Completion: June 30, 2022
• Study Completion: March 1, 2023
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share