Mindfulness-based Stress Reduction for Multiple Sclerosis

Browse trials for

• Multiple Sclerosis 3,460
• Sclerosis 3,124

Keywords

• mindfulness
• meditation
• stress, psychological
• quality of life
• randomized controlled trial

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 67 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Lead sponsor

National University of Natural Medicine is the lead sponsor of 38 studies on the registry; 8 are open to participants now.

Study arms

• Experimental
  Mindfulness-base Stress Reduction

  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

• Active comparator
  MS Education Control

  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

Interventions

• BehavioralMindfulness-based Stress Reduction

  Also known as: MBSR

• BehavioralMS Education Control

Primary outcomes

1. 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.

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

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.

   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'.

   Time frame: Baseline to 8 weeks

3. 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.

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

4. 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.

   Time frame: 14 months

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

   Mental health-related quality of life.

   Time frame: Baseline and 8 weeks

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

   Mental health-related quality of life.

   Time frame: 8 weeks and 12 months

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

   PROMIS Computerized Adaptive Test of Anxiety

   Time frame: Baseline and 8 weeks

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

   PROMIS Computerized Adaptive Test of Anxiety

   Time frame: 8 weeks and 12 months

7. Change in baseline PROMIS Depression Score to 8 weeks

   PROMIS Computerized Adaptive Test of Depression

   Time frame: Baseline and 8 weeks

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

   PROMIS Computerized Adaptive Test of Depression

   Time frame: 8 weeks and 12 months

9. Change in baseline PROMIS Fatigue Score to 8 weeks

   PROMIS Computerized Adaptive Test of Fatigue

   Time frame: Baseline and 8 weeks

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

    PROMIS Computerized Adaptive Test of Fatigue

    Time frame: 8 weeks and 12 months

11. Change in baseline PROMIS Pain Score to 8 weeks

    PROMIS Computerized Adaptive Test of Pain

    Time frame: Baseline and 8 weeks

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

    PROMIS Computerized Adaptive Test of Pain

    Time frame: 8 weeks and 12 months

Publications

• 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. PubMed 24647090 ↗
• 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. PubMed 25527612 ↗