Mindfulness-based Stress Reduction for Multiple Sclerosis

Study Overview
=================
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

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based Stress Reduction
* Behavioral: MS Education Control


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-base Stress Reduction<br>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<br> <br> * Other names: MBSR;|
| Active Comparator: MS Education Control<br>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<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness, meditation, stress, psychological, quality of life, randomized controlled trial