Mindfulness-based Stress Reduction for Multiple Sclerosis

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Mindfulness-based Stress Reduction; Behavioral: MS Education Control

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • National College of Natural Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness-based Stress Reduction; Other Names: MBSR
Active Comparator: 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.	Behavioral: MS Education Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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'.	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.	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.	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Perceived Stress Scale at 8 weeks		Baseline and 8 weeks
Change in Perceived Stress Scale from 8 weeks to 12 months		8 weeks and 12 months
Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks	Mental health-related quality of life.	Baseline and 8 weeks
Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months	Mental health-related quality of life.	8 weeks and 12 months
Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks	PROMIS Computerized Adaptive Test of Anxiety	Baseline and 8 weeks
Change in PROMIS Anxiety Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Anxiety	8 weeks and 12 months
Change in baseline PROMIS Depression Score to 8 weeks	PROMIS Computerized Adaptive Test of Depression	Baseline and 8 weeks
Change in PROMIS Depression Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Depression	8 weeks and 12 months
Change in baseline PROMIS Fatigue Score to 8 weeks	PROMIS Computerized Adaptive Test of Fatigue	Baseline and 8 weeks
Change in PROMIS Fatigue Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Fatigue	8 weeks and 12 months
Change in baseline PROMIS Pain Score to 8 weeks	PROMIS Computerized Adaptive Test of Pain	Baseline and 8 weeks
Change in PROMIS Pain Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Pain	8 weeks and 12 months

Collaborators and Investigators

• Sponsor: National University of Natural Medicine
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

General Publications

• Senders A, Bourdette D, Hanes D, Yadav V, Shinto L. Perceived stress in multiple sclerosis: the potential role of mindfulness in health and well-being. J Evid Based Complementary Altern Med. 2014 Apr;19(2):104-11. doi: 10.1177/2156587214523291. Epub 2014 Feb 20.
• Senders A, Sando K, Wahbeh H, Peterson Hiller A, Shinto L. Managing psychological stress in the multiple sclerosis medical visit: Patient perspectives and unmet needs. J Health Psychol. 2016 Aug;21(8):1676-87. doi: 10.1177/1359105314562084. Epub 2014 Dec 19.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 30, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: January 11, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: randomized controlled trial; quality of life; mindfulness; meditation; stress, psychological
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MBSR-MS-001; 1K23AT008211-01A1 (U.S. NIH Grant/Contract)