Mindfulness-based Stress Reduction for Multiple Sclerosis

NCT02340754 | Completed DMC

• 2 other identifiers: MBSR-MS-0011K23AT008211-01A1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

mindfulness; meditation; stress, psychological; quality of life; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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

  Baseline and 8 weeks

• Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months

  8 weeks and 12 months

• Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks

  Baseline and 8 weeks

Study Arms (2)

Mindfulness-base Stress Reduction

EXPERIMENTAL

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

MS Education Control

ACTIVE COMPARATOR

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

Interventions

Mindfulness-based Stress Reduction BEHAVIORAL

Also known as: MBSR

Mindfulness-base Stress Reduction

MS Education Control BEHAVIORAL

MS Education Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Natural Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

National College of Natural Medicine

Portland, Oregon, 97201, United States

Location

Related Publications (2)

• 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.

  PMID: 24647090 BACKGROUND

• 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.

  PMID: 25527612 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2015
• First Posted: January 19, 2015
• Study Start: May 1, 2015
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)