Back to resultsMindfulness Based Stress Reduction in Multiple Sclerosis (MS)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness based stress reduction (MBSR)
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring multiple sclerosis, glatiramer acetate, stress reduction, medication adherence
Eligibility 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.
Sites / Locations
- Stony Brook University
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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
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.
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.
Fatigue Severity Scale (FSS)
The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.
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.
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.
Physiologic Markers of Stress
DHEA, epinephrine, and norepinephrine.
Physiologic Maker of Stress
cortisol
Full Information
NCT ID
NCT01419301
First Posted
November 5, 2010
Last Updated
November 19, 2014
Sponsor
Stony Brook University
Collaborators
Teva Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT01419301
Brief Title
Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
Official Title
Mindfulness Based Stress Reduction in MS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
Teva Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, glatiramer acetate, stress reduction, medication adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction (MBSR)
Intervention Description
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 Measure Information:
Title
Electronic measure of needle disposals (MEMS TrackCaps)
Description
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.
Secondary Outcome Measure Information:
Title
Perceived Stress Scale-10
Description
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
Title
Holmes and Rahe Social Readjustment Rating Scale (SRRS
Description
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
Title
Chicago Multiscale Depression Inventory (CMDI)
Description
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
Title
State Trait Anxiety Inventory (STAI)
Description
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
Title
Positive and Negative Affect Scale (PANAS)
Description
; 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
Title
Fatigue Severity Scale (FSS)
Description
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
Title
MACFIMS neuropsychological battery
Description
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
Title
Expanded Disability Status Scale (EDSS)
Description
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
Title
Physiologic Markers of Stress
Description
DHEA, epinephrine, and norepinephrine.
Time Frame
Baseline and Week 8
Title
Physiologic Maker of Stress
Description
cortisol
Time Frame
Baseline, 1 X between Week 3 - 7, Weeek 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren B Krupp, M.D.
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11786-8121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
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