Meditation and Stretching for Post Treatment Lyme Disease Syndrome

NCT ID: NCT02344537

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2019-05-19

Brief Summary

The investigators wish to conduct a preliminary study to examine the efficacy of meditation among patients with Post Treatment Lyme Syndrome (PTLDS). Specifically, the investigators will use the breathing, meditation, and stretching techniques common to Kundalini Yoga practice. The investigators plan to assess the degree in which this practice can reduce Post-Treatment Lyme Disease symptoms. Because fatigue and pain are so common among patients with PTLDS, 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.

Detailed Description

The CDC reports that approximately 10-20% of patients treated for Lyme disease with the IDSA-recommended 2-4 week course of antibiotics will continue to have symptoms of fatigue, pain, or joint and muscle aches despite prior antibiotic treatment. The symptoms can last 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." Because some patients with PTLDS continue to have ongoing symptoms despite many additional courses of antibiotics beyond the standard course, alternative non-antibiotic treatment programs need to be explored. The proposed study seeks to evaluate the efficacy of meditation among those patients that have been previously treated for Lyme disease but are still continuing to experience prominent symptoms of fatigue and/or pain.

During this study, patients will be screened initially 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.

Conditions

Post Treatment Lyme Disease Syndrome

Study Design

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

Study Groups

Meditation Group Therapy

Kundalini Yoga incorporates mindfulness practice with a triad of stretching, breathing, and meditation. The three components of treatment consist of muscular relaxation/stretching exercises, a meditation period characterized by a directed breathing exercise, and then a guided meditation.

Group Type: EXPERIMENTAL

Kundalini Yoga

Intervention Type: BEHAVIORAL

Kundalini Yoga incorporates mindfulness practice with a triad of stretching, breathing, and meditation. The three components of treatment consist of muscular relaxation/stretching exercises, a meditation period characterized by a directed breathing exercise, and then a guided meditation.

Wait-List Controls

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). (After completing 8 weeks of no study treatment as part of the wait-list group, these patients will be offered the opportunity to receive 8 weeks of treatment.)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kundalini Yoga

Kundalini Yoga incorporates mindfulness practice with a triad of stretching, breathing, and meditation. The three components of treatment consist of muscular relaxation/stretching exercises, a meditation period characterized by a directed breathing exercise, and then a guided meditation.

Intervention Type: BEHAVIORAL

Other Intervention Names

Relaxation, stretching and meditation

Eligibility Criteria

Inclusion Criteria

• History of prior diagnosis of Lyme Disease at least 6 months prior to assessment

1. EM Rash seen by health professional

-OR-

2. History of physician diagnosed disseminated Lyme disease

• Previously treated for Lyme Disease with antibiotics appropriate for stage of disease
• Current symptoms of PTLDS started within 6 months after getting Lyme disease
• Current symptoms have been present for at least the last 6 months.
• Between the ages of 18 and 65, English speaking, male or female
• Primary complaint of fatigue or pain meeting predetermined severity criteria
• Individuals whose medical and/or psychiatric treatment has been stable for the prior 8 weeks
• 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.

Exclusion Criteria

• 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)
• 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)
• Individuals with severe depression
• 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, speak with study research assistant, or dedicate twenty minutes daily to meditation and stretching
• Suicide attempts within the last 6 months or current suicidal thoughts
• Individuals unwilling to delay starting optional treatment for Lyme disease for the duration of the study
• Individuals with a prior lifetime practice of at least one month of daily practice of MBSR or mindfulness or those who currently practice daily meditation or yoga

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Research Foundation for Mental Hygiene, Inc.

Locations

Private Practice Office of Dr. Alexander

Southport, Connecticut, United States

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

Collins C. Yoga: intuition, preventive medicine, and treatment. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):563-8. doi: 10.1111/j.1552-6909.1998.tb02623.x.

Reference Type: BACKGROUND

PMID: 9773368 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16262547 (View on PubMed)

van der Lee ML, Garssen B. Mindfulness-based cognitive therapy reduces chronic cancer-related fatigue: a treatment study. Psychooncology. 2012 Mar;21(3):264-72. doi: 10.1002/pon.1890. Epub 2010 Dec 19.

Reference Type: BACKGROUND

PMID: 22383268 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20876468 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

6927

Identifier Type: -

Identifier Source: org_study_id