Meditation and Kundalini Yoga for Persistent Lyme-related Symptoms - an Online Study
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|ClinicalTrials.gov Identifier: NCT04349605|
Recruitment Status : Withdrawn (Withdrawn given new information indicating a new study design would be preferable)
First Posted : April 16, 2020
Last Update Posted : June 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Post-Treatment Lyme Disease||Behavioral: Meditation Behavioral: Kundalini Yoga||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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)|
|Official Title:||Meditation and Yoga for Patients With Persistent Symptoms After Lyme Disease|
|Estimated Study Start Date :||June 20, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||March 1, 2023|
This is a daily 15 minute meditation with guided breathing. Accessible through an app.
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.
- Fatigue Severity Scale [ Time Frame: Up to 24 weeks ]A Fatigue impact measure
- General Symptom Questionnaire-30 [ Time Frame: Up to 24 weeks ]A self-report measure of multi-system symptom burden
- Quality of Life Experience Scale [ Time Frame: Up to 24 weeks ]A measure of qualify of life
- Pain Visual Analog Scale [ Time Frame: Up to 24 weeks ]A self-report measure of pain severity
- Applied Cognition scale [ Time Frame: Up to 24 weeks ]A self-report measure of cognitive function
- PROMIS-29 [ Time Frame: Up to 24 weeks ]A self-report measure of seven symptom and functional domains
- SF-12 [ Time Frame: Up to 24 weeks ]A self-report measure of physical and mental functioning
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349605
|Principal Investigator:||Brian A Fallon, MD||Columbia University|