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Mindfulness-based Stress Reduction for Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based Stress Reduction
MS Education Control
Sponsored by
National University of Natural Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring mindfulness, meditation, stress, psychological, quality of life, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • National College of Natural Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-base Stress Reduction

MS Education Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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'.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2015
Last Updated
April 6, 2018
Sponsor
National University of Natural Medicine
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02340754
Brief Title
Mindfulness-based Stress Reduction for Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Natural Medicine
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
mindfulness, meditation, stress, psychological, quality of life, randomized controlled trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-base Stress Reduction
Arm Type
Experimental
Arm 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.
Arm Title
MS Education Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Type
Behavioral
Intervention Name(s)
MS Education Control
Primary Outcome Measure Information:
Title
Recruitment: Number of participants enrolled over a ten-month period
Description
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..
Title
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.
Description
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
Title
Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
Description
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.
Title
Completion: Number of participants with complete follow-up at 12 months post-intervention.
Description
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.
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Change from baseline in Perceived Stress Scale at 8 weeks
Time Frame
Baseline and 8 weeks
Title
Change in Perceived Stress Scale from 8 weeks to 12 months
Time Frame
8 weeks and 12 months
Title
Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks
Description
Mental health-related quality of life.
Time Frame
Baseline and 8 weeks
Title
Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
Description
Mental health-related quality of life.
Time Frame
8 weeks and 12 months
Title
Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
Description
PROMIS Computerized Adaptive Test of Anxiety
Time Frame
Baseline and 8 weeks
Title
Change in PROMIS Anxiety Score from 8 weeks to 12 months
Description
PROMIS Computerized Adaptive Test of Anxiety
Time Frame
8 weeks and 12 months
Title
Change in baseline PROMIS Depression Score to 8 weeks
Description
PROMIS Computerized Adaptive Test of Depression
Time Frame
Baseline and 8 weeks
Title
Change in PROMIS Depression Score from 8 weeks to 12 months
Description
PROMIS Computerized Adaptive Test of Depression
Time Frame
8 weeks and 12 months
Title
Change in baseline PROMIS Fatigue Score to 8 weeks
Description
PROMIS Computerized Adaptive Test of Fatigue
Time Frame
Baseline and 8 weeks
Title
Change in PROMIS Fatigue Score from 8 weeks to 12 months
Description
PROMIS Computerized Adaptive Test of Fatigue
Time Frame
8 weeks and 12 months
Title
Change in baseline PROMIS Pain Score to 8 weeks
Description
PROMIS Computerized Adaptive Test of Pain
Time Frame
Baseline and 8 weeks
Title
Change in PROMIS Pain Score from 8 weeks to 12 months
Description
PROMIS Computerized Adaptive Test of Pain
Time Frame
8 weeks and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National College of Natural Medicine
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24647090
Citation
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.
Results Reference
background
PubMed Identifier
25527612
Citation
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.
Results Reference
background

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Mindfulness-based Stress Reduction for Multiple Sclerosis

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