Mindfulness-based Stress Reduction for Multiple Sclerosis

National University of Natural Medicine67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Mindfulness-based Stress ReductionBEHAVIORAL

MS Education ControlBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

National College of Natural Medicine

Portland, Oregon, United States

Outcomes

Primary Outcomes

Recruitment: Number of participants enrolled over a ten-month period

Feasible recruitment is defined as the ability to recruit and enroll 60 participants with multiple sclerosis (MS) over a ten-month time frame. Recruitment rate will be calculated as the proportion of eligible patients who provided informed consent per month.

Time frame: Recruitment will be tracked monthly with an expected recruitment period of 10 months..

Adherence to Mindfulness-based Stress Reduction (MBSR): Number of Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework.

Adherence will be tracked with a sign-in/sign out sheet at each class and with daily homework logs. Attendance will be calculated by a sign in/sign out sheet, being present for at least 75% of a class will count as attended. Homework will be tabulated as both a frequency count (number of days homework was completed) and amount (total number of minutes completed). Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework will be recorded as 'adherent'.

Time frame: Baseline to 8 weeks

Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.

Adoption is defined as the ability of participants to take part in activities such as yoga poses and meditative exercises. Qualitative outcomes include a brief, semi-structured focus group conducted at the beginning of the MBSR classes during weeks five and eight. Focus groups will address successes and any challenges participants may be experiencing. Focus groups will be audio recorded and transcribed verbatim for qualitative analysis.

Time frame: Week 4 and week 8 of the 8 week intervention.

Completion: Number of participants with complete follow-up at 12 months post-intervention.

A feasible completion rate is defined as complete follow-up in at least 70% of enrolled subjects at 12-months post-intervention. Completion indicates acceptability of a long-term trial and will inform future study designs.

Data from ClinicalTrials.gov

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