Mindfulness Based Stress Reduction in MS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stony Brook University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Electronic measure of needle disposals (MEMS TrackCaps)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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 Outcomes
- Perceived Stress Scale-10(Baseline, 1 X between weeks 3-7, Week 8)
- Chicago Multiscale Depression Inventory (CMDI)(Baseline, 1 X betweeen Weeks 3-7, Week 8)
- State Trait Anxiety Inventory (STAI)(Baseline, 1 X betweeen Weeks 3-7, Week 8)
- Holmes and Rahe Social Readjustment Rating Scale (SRRS(Baseline, 1 X between weeks 3-7, Week 8)
- Positive and Negative Affect Scale (PANAS)(Baseline, 1 X between Weeks 3 - 7, Week 8)
- Fatigue Severity Scale (FSS)(Baseline, 1 X between Weeks 3 - 7, Week 8)
- Expanded Disability Status Scale (EDSS)(Baseline and Week 8)
- Physiologic Markers of Stress(Baseline and Week 8)
- Physiologic Maker of Stress(Baseline, 1 X between Week 3 - 7, Weeek 8)
- MACFIMS neuropsychological battery(Baseline and Week 8)
Investigators
Lauren Krupp
Professor
Stony Brook University