An interventional study of Mindfulness based stress reduction (MBSR) in Multiple Sclerosis, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-11-20.
Sponsored by Stony Brook University · Not applicable, Interventional, and Supportive care
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.
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Exclusion Criteria:
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.
Electronic measure of needle disposals (MEMS TrackCaps)
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.
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.
Perceived Stress Scale-10
A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.
Time frame: Baseline, 1 X between weeks 3-7, Week 8
Holmes and Rahe Social Readjustment Rating Scale (SRRS
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).
Time frame: Baseline, 1 X between weeks 3-7, Week 8
Chicago Multiscale Depression Inventory (CMDI)
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
Time frame: Baseline, 1 X betweeen Weeks 3-7, Week 8
State Trait Anxiety Inventory (STAI)
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.
Time frame: Baseline, 1 X betweeen Weeks 3-7, Week 8
Positive and Negative Affect Scale (PANAS)
; Watson, Clark \& Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.
Time frame: Baseline, 1 X between Weeks 3 - 7, Week 8
Fatigue Severity Scale (FSS)
The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.
Time frame: Baseline, 1 X between Weeks 3 - 7, Week 8
MACFIMS neuropsychological battery
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.
Time frame: Baseline and Week 8
Expanded Disability Status Scale (EDSS)
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.
Time frame: Baseline and Week 8
Physiologic Markers of Stress
DHEA, epinephrine, and norepinephrine.
Time frame: Baseline and Week 8
Physiologic Maker of Stress
cortisol
Time frame: Baseline, 1 X between Week 3 - 7, Weeek 8
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Stony Brook University