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

November 5, 2010
August 16, 2011
May 2011
November 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01419301 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
Mindfulness Based Stress Reduction in MS

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Multiple Sclerosis
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
69
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Not Provided
United States
 
NCT01419301
Teva186557-1
No
Lauren B. Krupp, Stony Brook University
Stony Brook University
Teva Pharmaceuticals USA
Principal Investigator: Lauren B Krupp, M.D. Stony Brook University
Stony Brook University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP