Clinical trial NCT02340754: Mindfulness-based Stress Reduction for Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: mindfulness
meditation
stress, psychological
quality of life
randomized controlled trial
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-01-19
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Recruitment: Number of participants enrolled over a ten-month period
timeFrame: Recruitment will be tracked monthly with an expected recruitment period of 10 months..
measure: 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.
timeFrame: Baseline to 8 weeks
measure: Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.
timeFrame: Week 4 and week 8 of the 8 week intervention.
measure: Completion: Number of participants with complete follow-up at 12 months post-intervention.
timeFrame: 14 months
Secondary outcomes:
measure: Change from baseline in Perceived Stress Scale at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change in Perceived Stress Scale from 8 weeks to 12 months
timeFrame: 8 weeks and 12 months
measure: Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months
timeFrame: 8 weeks and 12 months
measure: Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change in PROMIS Anxiety Score from 8 weeks to 12 months
timeFrame: 8 weeks and 12 months
measure: Change in baseline PROMIS Depression Score to 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change in PROMIS Depression Score from 8 weeks to 12 months
timeFrame: 8 weeks and 12 months
measure: Change in baseline PROMIS Fatigue Score to 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change in PROMIS Fatigue Score from 8 weeks to 12 months
timeFrame: 8 weeks and 12 months
measure: Change in baseline PROMIS Pain Score to 8 weeks
timeFrame: Baseline and 8 weeks
measure: Change in PROMIS Pain Score from 8 weeks to 12 months
timeFrame: 8 weeks and 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: National College of Natural Medicine
state: Oregon
Study officials:
References:
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.
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.