Mindfulness-based Stress Reduction for Multiple Sclerosis

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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-30

Brief Summary

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The primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared to an education control group; and 2) Explore the durability of the effects of MBSR over one year.

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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

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness-base Stress Reduction

Mindfulness-based stress reduction is a formalized, experiential, 8-week stress-management program. Participants attend weekly two-hour classes and a half-day retreat during which they learn mindfulness meditation, breath work, yoga postures, self-reflection and awareness.

Group Type EXPERIMENTAL

Mindfulness-based Stress Reduction

Intervention Type BEHAVIORAL

MS Education Control

The MS Education Control program is matched to MBSR for time and attention yet has no overlap with intervention content. Each two-hour class uses a pamphlet published by the National MS Society to present information about a different MS topic such as Fatigue; Bowel and Bladder Problems; Diet; Spasticity; and Nutritional Supplementation: Vitamins, Minerals, and Herbs.

Group Type ACTIVE_COMPARATOR

MS Education Control

Intervention Type BEHAVIORAL

Interventions

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Mindfulness-based Stress Reduction

Intervention Type BEHAVIORAL

MS Education Control

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR

Eligibility Criteria

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Inclusion Criteria

* Men and women 18 years of age or older
* Definite relapsing remitting, secondary progressive, or primary progressive MS by revised McDonald criteria;
* Expanded Disability Severity Scale ≤ 8 at baseline;
* Stable on MS disease modifying, anxiolytic, or antidepressant medications for three months prior to baseline visit;
* Mild to moderate stress defined by a score of ≥ 10 on the Perceived Stress Scale at screening;
* Ability to read and write in English;
* Willingness to provide informed consent and comply with study activities, including weekly MBSR sessions and daily practice or weekly Education Control classes.

Exclusion Criteria

* MBSR or cognitive behavioral therapy training within the last 5 years;
* Current regular meditation or yoga practice (weekly or more often);
* MS exacerbation within 30 days of Baseline Visit;
* Mini-Mental Status Examination (MMSE) score of ≤ 26 at Screening Visit;
* Active suicidal ideation (Beck Depression Inventory) at Screening Visit;
* Reported or medically recorded diagnoses of current serious psychological disorders other than depression and anxiety;
* Other current life-threatening or severely disabling physical disorders;
* Positive pregnancy urine test at Baseline and women planning pregnancy during the study period (contraception not required);
* Cancer, other than basal or squamous skin cancers; or
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No