Mindfulness-based Stress Reduction for Multiple Sclerosis

National University of Natural Medicine (NUNM)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: MS Education Control; Behavioral: Mindfulness-based Stress Reduction

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02340754

MBSR-MS-001

1K23AT008211-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups

Mindfulness-base Stress Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-based Stress Reduction

MS Education Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: MS Education Control