Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

N/ACompletedNCT01419301

Stony Brook University31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Mindfulness based stress reduction (MBSR)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stony Brook University

Stony Brook, New York, United States

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.