Mindfulness-based Stress Reduction for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340754
• Other study ID #: MBSR-MS-001
• Secondary ID: 1K23AT008211-01A
• Status: Completed
• Phase: N/A
• First received: January 11, 2015
• Last updated: April 6, 2018
• Start date: May 2015
• Est. completion date: May 30, 2017

Study information

• Verified date: April 2018
• Source: National University of Natural Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Mindfulness-based Stress Reduction

• MS Education Control

Locations

Country	Name	City	State
United States	National College of Natural Medicine	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
National University of Natural Medicine	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..
Primary	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
Primary	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.
Primary	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	Change from baseline in Perceived Stress Scale at 8 weeks		Baseline and 8 weeks
Secondary	Change in Perceived Stress Scale from 8 weeks to 12 months		8 weeks and 12 months
Secondary	Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks	Mental health-related quality of life.	Baseline and 8 weeks
Secondary	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
Secondary	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
Secondary	Change in PROMIS Anxiety Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Anxiety	8 weeks and 12 months
Secondary	Change in baseline PROMIS Depression Score to 8 weeks	PROMIS Computerized Adaptive Test of Depression	Baseline and 8 weeks
Secondary	Change in PROMIS Depression Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Depression	8 weeks and 12 months
Secondary	Change in baseline PROMIS Fatigue Score to 8 weeks	PROMIS Computerized Adaptive Test of Fatigue	Baseline and 8 weeks
Secondary	Change in PROMIS Fatigue Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Fatigue	8 weeks and 12 months
Secondary	Change in baseline PROMIS Pain Score to 8 weeks	PROMIS Computerized Adaptive Test of Pain	Baseline and 8 weeks
Secondary	Change in PROMIS Pain Score from 8 weeks to 12 months	PROMIS Computerized Adaptive Test of Pain	8 weeks and 12 months