Meditation and Stretching for Post Treatment Lyme Disease Syndrome

NCT02344537 | Terminated Results

• 1 other identifier: 6927
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Treatment Lyme Disease Syndrome

Keywords

Lyme DIsease; Kundalini Yoga

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (5)

• Physical Functioning (as Measured by the PROMIS Physical Functioning Scale)

  Assessed at weeks 4 and 8; week 8 data reported (primary endpoint). Month 6 assessment not conducted.

• General Symptom Questionnaire-30 (Self-reported Symptom Burden)

  Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). Month 6 assessment not conducted.

• Beck Depression Inventory

  Assessed at weeks 4 and 8; 8 week data is reported (primary endpoint). Month 6 assessment not conducted.

• PROMIS Social Satisfaction

  Assessed at 4 and 8 weeks; 8 week values are reported (primary endpoint). 6 month assessment was not conducted. .

• Applied Cognition General Concerns Short-form

  Assessed and 4 and 8 weeks; the 8 week results are reported (primary outcome timepoint). The 6 month assessment was not conducted.

Study Arms (2)

Meditation Group Therapy

EXPERIMENTAL

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.

Behavioral: Kundalini Yoga

Wait-List Controls

NO INTERVENTION

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.)

Interventions

Kundalini Yoga 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.

Also known as: Relaxation, stretching and meditation

Meditation Group Therapy

Eligibility Criteria

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

You may qualify if:

• History of prior diagnosis of Lyme Disease at least 6 months prior to assessment
• EM Rash seen by health professional
• OR-
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead

Study Sites (2)

Private Practice Office of Dr. Alexander

Southport, Connecticut, 06890, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (4)

• 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.

  PMID: 9773368 BACKGROUND

• 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

• 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.

  PMID: 22383268 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

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

Results Point of Contact

• Title: Brian Fallon, MD
• Organization: New York State Psychiatric Institute

brian.fallon@nyspi.columbia.edu

6467748052

Study Officials

• Brian A Fallon, MD

  Research Foundation for Mental Hygiene, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 26, 2015
• Study Start: November 1, 2015
• Primary Completion: May 19, 2019
• Study Completion: May 19, 2019
• Last Updated: September 25, 2023
• Results First Posted: September 25, 2023

Record last verified: 2022-11

Locations

US (2)