Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419301
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : November 20, 2014
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Lauren Krupp, Stony Brook University

Brief Summary:

This study focuses on stress, cognition, mood and fatigue and its effect on medication compliance. Medication compliance is measured by the weight of discarded needles. The investigators will be administering neuropsychological testing at baseline and the final visit. The subjects will complete self-report assessments during their 8 weeks in the study.

Group A will have additional weekly phone support for meditation, while Group B will have meditation training only.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Mindfulness based stress reduction (MBSR) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Mindfulness Based Stress Reduction in MS
Study Start Date : May 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Intervention Details:
  • Behavioral: Mindfulness based stress reduction (MBSR)
    Mindfulness based stress reduction (MBSR) is program based on daily meditation practice that guides an individual towards increased awareness and self-regulation of thoughts and actions. MBSR is easier to implement and may be shown to be more effective than cognitive-behavioral stress reduction, and is more applicable to patients with chronic illness.

Primary Outcome Measures :
  1. Electronic measure of needle disposals (MEMS TrackCaps) [ Time Frame: Medication adherence will be measured by total number of missed doses, calculated from total needle disposals. The total number of missed doses across the six weeks will be compared between the two treatment groups at study end. ]
    During the six-week MSBR program, medication adherence will be monitored with a widely used electronic measure of needle disposals (MEMS TrackCaps) This method has been demonstrated to be more accurate in MS than data obtained from either self-report or interview. At one month intervals the patient will bring the needle container to the Study Coordinator. All patients who attend at least introduction session and one telephone session will be included in the analysis.

Secondary Outcome Measures :
  1. Perceived Stress Scale-10 [ Time Frame: Baseline, 1 X between weeks 3-7, Week 8 ]
    A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.

  2. Holmes and Rahe Social Readjustment Rating Scale (SRRS [ Time Frame: Baseline, 1 X between weeks 3-7, Week 8 ]
    Stressful life events will be rated using the SRRS, which asks subjects to check if they have experienced any of a series of life events. We will use a modification of the scale used in previous MS research that eliminates several items specifically associated with MS disease activity (e.g., "major illness or injury", "sexual difficulties", "pregnancy"). The SRRS differentiates three types of stress: positive ("outstanding personal achievement"), major negative stress (death of family member), conflict and disruption in routine (e.g., family or job conflict, life changes).

  3. Chicago Multiscale Depression Inventory (CMDI) [ Time Frame: Baseline, 1 X betweeen Weeks 3-7, Week 8 ]
    CMDI is a self-report questionnaire designed specifically for use in MS and other medical patient groups. It has vegetative, mood, and evaluative scales consisting of 14 items each. The use of the CMDI makes it possible to separate out neurovegetative symptoms of depression which are a potential confound in medical populations such as MS

  4. State Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 1 X betweeen Weeks 3-7, Week 8 ]
    The STAI is a widely used measure of state and trait anxiety. We will focus on the measurement of state related anxiety in this study.

  5. Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline, 1 X between Weeks 3 - 7, Week 8 ]
    ; Watson, Clark & Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.

  6. Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 1 X between Weeks 3 - 7, Week 8 ]
    The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.

  7. MACFIMS neuropsychological battery [ Time Frame: Baseline and Week 8 ]
    At baseline and study end, an abbreviated version of the MACFIMS will be administered. This is a standard neurocognitive battery used with studies of MS subjects and includes the SDMT, PASAT, SRT, BVMT, and 9-hole peg test.

  8. Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline and Week 8 ]
    Expanded Disability Status Scale is the oldest and probably the most widely utilized assessment instruments in MS for determination of neurological impairment in MS. It is the standard for characterization of MS patients and for outcomes of clinical trials. It will be used to characterize patients' level of disability.

  9. Physiologic Markers of Stress [ Time Frame: Baseline and Week 8 ]
    DHEA, epinephrine, and norepinephrine.

  10. Physiologic Maker of Stress [ Time Frame: Baseline, 1 X between Week 3 - 7, Weeek 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with either definite MS according to the revised McDonald criteria (Polman 2005) or patients with CIS (defined as an initial MS relapse with objective documentation and 2 or more lesions within the CNS of which at least one must involve the brain)
  • Patients on GA therapy for at least 6 months
  • Age 18 - 70

Exclusion Criteria:

  • Unwilling to comply with study procedures
  • Use of other DMT in conjunction with GA
  • Unable to provide informed consent.
  • Current (past 30 days) substance abuse
  • Newly initiated (past 30 days) psychiatry treatment
  • Enrolled in another program of meditation in the past six months.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01419301

United States, New York
Stony Brook University
Stony Brook, New York, United States, 11786-8121
Sponsors and Collaborators
Stony Brook University
Teva Pharmaceuticals USA
Principal Investigator: Lauren B Krupp, M.D. Stony Brook University

Responsible Party: Lauren Krupp, Professor, Stony Brook University Identifier: NCT01419301     History of Changes
Other Study ID Numbers: Teva186557-1
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Lauren Krupp, Stony Brook University:
multiple sclerosis
glatiramer acetate
stress reduction
medication adherence

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases