Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

November 19, 2014 updated by: Lauren Krupp, Stony Brook University

Mindfulness Based Stress Reduction in MS

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11786-8121
        • Stony Brook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale-10
Time Frame: Baseline, 1 X between weeks 3-7, Week 8
A 10-item scale of global perceived stress, where each item is rated from 1 to 5 according to intensity of stressor.
Baseline, 1 X between weeks 3-7, Week 8
Holmes and Rahe Social Readjustment Rating Scale (SRRS
Time Frame: Baseline, 1 X between weeks 3-7, Week 8
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).
Baseline, 1 X between weeks 3-7, Week 8
Chicago Multiscale Depression Inventory (CMDI)
Time Frame: Baseline, 1 X betweeen Weeks 3-7, Week 8
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
Baseline, 1 X betweeen Weeks 3-7, Week 8
State Trait Anxiety Inventory (STAI)
Time Frame: Baseline, 1 X betweeen Weeks 3-7, Week 8
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.
Baseline, 1 X betweeen Weeks 3-7, Week 8
Positive and Negative Affect Scale (PANAS)
Time Frame: Baseline, 1 X between Weeks 3 - 7, Week 8
; Watson, Clark & Tellegen, 1989): State related positive and negative affect will be assessed by the well validated PANAS scales.
Baseline, 1 X between Weeks 3 - 7, Week 8
Fatigue Severity Scale (FSS)
Time Frame: Baseline, 1 X between Weeks 3 - 7, Week 8
The fatigue severity scale is a reliable and valid commonly used measure of the frequent symptom of fatigue in MS.
Baseline, 1 X between Weeks 3 - 7, Week 8
MACFIMS neuropsychological battery
Time Frame: Baseline and Week 8
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.
Baseline and Week 8
Expanded Disability Status Scale (EDSS)
Time Frame: Baseline and Week 8
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.
Baseline and Week 8
Physiologic Markers of Stress
Time Frame: Baseline and Week 8
DHEA, epinephrine, and norepinephrine.
Baseline and Week 8
Physiologic Maker of Stress
Time Frame: Baseline, 1 X between Week 3 - 7, Weeek 8
cortisol
Baseline, 1 X between Week 3 - 7, Weeek 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

Teva Pharmaceuticals USA

Investigators

  • Principal Investigator: Lauren B Krupp, M.D., Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

August 16, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Teva186557-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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