Clinical trial NCT01419301: Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)
Official title: Mindfulness Based Stress Reduction in MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
glatiramer acetate
stress reduction
medication adherence
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2011-08-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Electronic measure of needle disposals (MEMS TrackCaps)
timeFrame: 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 outcomes:
measure: Perceived Stress Scale-10
timeFrame: Baseline, 1 X between weeks 3-7, Week 8
measure: Holmes and Rahe Social Readjustment Rating Scale (SRRS
timeFrame: Baseline, 1 X between weeks 3-7, Week 8
measure: Chicago Multiscale Depression Inventory (CMDI)
timeFrame: Baseline, 1 X betweeen Weeks 3-7, Week 8
measure: State Trait Anxiety Inventory (STAI)
timeFrame: Baseline, 1 X betweeen Weeks 3-7, Week 8
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline, 1 X between Weeks 3 - 7, Week 8
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, 1 X between Weeks 3 - 7, Week 8
measure: MACFIMS neuropsychological battery
timeFrame: Baseline and Week 8
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline and Week 8
measure: Physiologic Markers of Stress
timeFrame: Baseline and Week 8
measure: Physiologic Maker of Stress
timeFrame: Baseline, 1 X between Week 3 - 7, Weeek 8
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Lauren B Krupp, M.D.
role: PRINCIPAL_INVESTIGATOR
References: