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Completed

NCT Number: NCT02340754

Mindfulness-based Stress Reduction for Multiple Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National College of Natural Medicine

Portland, Oregon, 97201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

Other names: MBSR

MS Education Control

Behavioral

Primary outcomes

  1. Recruitment: Number of participants enrolled over a ten-month period

    Time frame: Recruitment will be tracked monthly with an expected recruitment period of 10 months..

    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.

  2. 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.

    Time frame: Baseline to 8 weeks

    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'.

  3. Adoption: Qualitative assessment of facilitators of and barriers to participation in the MBSR program.

    Time frame: Week 4 and week 8 of the 8 week intervention.

    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.

  4. Completion: Number of participants with complete follow-up at 12 months post-intervention.

    Time frame: 14 months

    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 outcomes

  1. Change from baseline in Perceived Stress Scale at 8 weeks

    Time frame: Baseline and 8 weeks

  2. Change in Perceived Stress Scale from 8 weeks to 12 months

    Time frame: 8 weeks and 12 months

  3. Change from baseline in Short Form-36 Mental Health Subscale to 8 weeks

    Time frame: Baseline and 8 weeks

    Mental health-related quality of life.

  4. Change in Short Form-36 Mental Health Subscale from 8 weeks to 12 months

    Time frame: 8 weeks and 12 months

    Mental health-related quality of life.

  5. Change in baseline Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score to 8 weeks

    Time frame: Baseline and 8 weeks

    PROMIS Computerized Adaptive Test of Anxiety

  6. Change in PROMIS Anxiety Score from 8 weeks to 12 months

    Time frame: 8 weeks and 12 months

    PROMIS Computerized Adaptive Test of Anxiety

  7. Change in baseline PROMIS Depression Score to 8 weeks

    Time frame: Baseline and 8 weeks

    PROMIS Computerized Adaptive Test of Depression

  8. Change in PROMIS Depression Score from 8 weeks to 12 months

    Time frame: 8 weeks and 12 months

    PROMIS Computerized Adaptive Test of Depression

  9. Change in baseline PROMIS Fatigue Score to 8 weeks

    Time frame: Baseline and 8 weeks

    PROMIS Computerized Adaptive Test of Fatigue

  10. Change in PROMIS Fatigue Score from 8 weeks to 12 months

    Time frame: 8 weeks and 12 months

    PROMIS Computerized Adaptive Test of Fatigue

  11. Change in baseline PROMIS Pain Score to 8 weeks

    Time frame: Baseline and 8 weeks

    PROMIS Computerized Adaptive Test of Pain

  12. Change in PROMIS Pain Score from 8 weeks to 12 months

    Time frame: 8 weeks and 12 months

    PROMIS Computerized Adaptive Test of Pain

Sponsors and collaborators

Lead sponsor

National University of Natural Medicine

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2015
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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