Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Stony Brook University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT01419301
First received: November 5, 2010
Last updated: August 16, 2011
Last verified: August 2011
  Purpose

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 Intervention
Multiple Sclerosis
Behavioral: Mindfulness based stress reduction (MBSR)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Mindfulness Based Stress Reduction in MS

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Perceived Stress Scale-10 [ Time Frame: Baseline, 1 X between weeks 3-7, Week 8 ] [ Designated as safety issue: No ]
    A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.

  • Holmes and Rahe Social Readjustment Rating Scale (SRRS [ Time Frame: Baseline, 1 X between weeks 3-7, Week 8 ] [ Designated as safety issue: No ]
    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).

  • Chicago Multiscale Depression Inventory (CMDI) [ Time Frame: Baseline, 1 X betweeen Weeks 3-7, Week 8 ] [ Designated as safety issue: No ]
    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

  • State Trait Anxiety Inventory (STAI) [ Time Frame: Baseline, 1 X betweeen Weeks 3-7, Week 8 ] [ Designated as safety issue: No ]
    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.

  • Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline, 1 X between Weeks 3 - 7, Week 8 ] [ Designated as safety issue: No ]
    ; Watson, Clark & Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.

  • Fatigue Severity Scale (FSS) [ Time Frame: Baseline, 1 X between Weeks 3 - 7, Week 8 ] [ Designated as safety issue: No ]
    The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.

  • MACFIMS neuropsychological battery [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.

  • Physiologic Markers of Stress [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    DHEA, epinephrine, and norepinephrine.

  • Physiologic Maker of Stress [ Time Frame: Baseline, 1 X between Week 3 - 7, Weeek 8 ] [ Designated as safety issue: No ]
    cortisol


Estimated Enrollment: 69
Study Start Date: May 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419301

Locations
United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11786-8121
Contact: Patricia Melville, NP    631-444-8068    pmelville@notes.cc.sunysb.edu   
Sponsors and Collaborators
Stony Brook University
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Lauren B Krupp, M.D. Stony Brook University
  More Information

No publications provided

Responsible Party: Lauren B. Krupp, Stony Brook University
ClinicalTrials.gov Identifier: NCT01419301     History of Changes
Other Study ID Numbers: Teva186557-1
Study First Received: November 5, 2010
Last Updated: August 16, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014