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

NCT ID: NCT04349605

Last Updated: 2021-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-20
• Study Completion Date: 2023-03-01

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.

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.

Conditions

Post-Treatment Lyme Disease

Keywords

Lyme disease; Kundalini Yoga; Meditation; Chronic Lyme Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meditation

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

Group Type: EXPERIMENTAL

Meditation

Intervention Type: BEHAVIORAL

Meditation involves guided breathing and mindfulness training.

Kundalini Yoga

This is a daily 30 minute practice of Kundalini Yoga (stretching, guided breathing, and meditation). Accessible by smart phone, tablet or computer.

Group Type: EXPERIMENTAL

Kundalini Yoga

Intervention Type: BEHAVIORAL

Kundalini Yoga involves stretching, guided breathing and meditation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meditation

Meditation involves guided breathing and mindfulness training.

Intervention Type: BEHAVIORAL

Kundalini Yoga

Kundalini Yoga involves stretching, guided breathing and meditation

Intervention Type: BEHAVIORAL

Eligibility 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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Brian A Fallon

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian A Fallon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

References

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Reference Type: BACKGROUND

PMID: 16262547 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 20876468 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31780963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29331704 (View on PubMed)

Other Identifiers

7613

Identifier Type: -

Identifier Source: org_study_id