Mindfulness-based Stress Reduction for Multiple Sclerosis
Mindfulness-based Stress Reduction for Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Mindfulness-based Stress Reduction
Compared with
- MS Education Control
What it measured
Main measures
Recruitment: Number of participants enrolled over a ten-month period
Recruitment will be tracked monthly with an expected recruitment period of 10 months..
FeasibilityAdherence 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.
Baseline to 8 weeks
Quality of life (reported by participants)Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
Week 4 and week 8 of the 8 week intervention.
Physical functionCompletion: Number of participants with complete follow-up at 12 months post-intervention.
14 months
Feasibility
Other measures (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
Quality of life (reported by participants)Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
8 weeks and 12 months
Quality of life (reported by participants)Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
Baseline and 8 weeks
Mood and sleepQuality of life (reported by participants)Change in PROMIS Anxiety Score from 8 weeks to 12 months
8 weeks and 12 months
Mood and sleepChange in baseline PROMIS Depression Score to 8 weeks
Baseline and 8 weeks
Mood and sleepChange in PROMIS Depression Score from 8 weeks to 12 months
8 weeks and 12 months
Mood and sleepChange in baseline PROMIS Fatigue Score to 8 weeks
Baseline and 8 weeks
FatigueChange in PROMIS Fatigue Score from 8 weeks to 12 months
8 weeks and 12 months
Fatigue
Who could take part
Relapsing and progressive · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Impact of mindfulness-based stress reduction for people with multiple sclerosis at 8 weeks and 12 months: A randomized clinical trial.Mult Scler · 2019
Background
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.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.
Loading reviews and guidelines…
History
Started
May 2015
Main results due
May 2017
Finished
May 2017