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Mindfulness Based Stress Reduction in Multiple Sclerosis (MS)

NCT ID: NCT01419301

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Interventions

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Mindfulness based stress reduction (MBSR)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Lauren Krupp

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauren B Krupp, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Stony Brook University

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Teva186557-1

Identifier Type: -

Identifier Source: org_study_id