Meditation and Stretching for Post Treatment Lyme Disease Syndrome

Post Treatment Lyme Disease Syndrome Clinical Trial

— LMS  

Official title:

Meditation and Stretching for Post Treatment Lyme Disease Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02344537
• Other study ID #: 6927
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: May 19, 2019

Study information

• Verified date: November 2022
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: May 19, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lyme Disease
• Post Treatment Lyme Disease Syndrome
• Syndrome

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York
United States	Private Practice Office of Dr. Alexander	Southport	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue (Self-reported Level of Fatigue as Measured by the PROMIS Fatigue Scale)	Self-reported assessment of fatigue as measured by the 7 item PROMIS Fatigue Scale. The raw score range is 7-35. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater fatigue	Assessed at week 4 and 8; week 8 value is reported (primary endpoint). 6 month assessment not conducted.
Primary	Pain Interference (PROMIS Pain Interference Scale)	Self-reported assessment of pain interference as measured by the 6-item PROMIS Pain Interference Scale. The raw score range is 6-30. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater pain interference.	Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). 6 month assessment not conducted.
Primary	Global Health (Self-reported Levels of Satisfaction With Global Health)	Self-reported assessment of satisfaction with global health as measured by the 1st item ( a 5 point scale, range 1-5) on the PROMIS Global Heath Scale where higher scores indicate greater satisfaction with health.	Assessed at week 4 and 8; week 8 is reported (primary endpoint). 6 month assessment not conducted.
Secondary	Physical Functioning (as Measured by the PROMIS Physical Functioning Scale)	Self-reported assessment of physical functioning as measured by the PROMIS Physical Functioning 8 item Scale. Raw score range 8-40. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate better physical functioning.	Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted.
Secondary	General Symptom Questionnaire-30 (Self-reported Symptom Burden)	Self-reported assessment of symptom burden as measured by the 30 item multisystem Global Symptom Questionnaire. Range is 0-120 where higher scores indicate greater symptom burden	Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted.
Secondary	Beck Depression Inventory	Self reported mood as measured by the 21 item Beck Depression Inventory. Range is 0-63 where higher scores indicate greater depression.	Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted.
Secondary	PROMIS Social Satisfaction	Assesses satisfaction with social functioning. 8 item scale. Raw score range i 8-40). The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. HIgher scores indicate greater satisfaction with social functioning.	Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. .
Secondary	Applied Cognition General Concerns Short-form	This self-report NeuroQoL measure assesses general concerns about cognition. This is an 8 item scale, with raw scores ranging from 8 to 40. The raw score is converted to a T-score with a mean of 50 and a standard deviation of 10; the results reported here are the T-scores. Higher scores mean fewer cognitive concerns.	Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted.