Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M)

Alice Pressman, Heather Law, Robert Stahl, Alex Scott, Alice Jacobson, Lisa Dean, Sylvia Sudat, Angelica Obillo, Andrew Avins, Alice Pressman, Heather Law, Robert Stahl, Alex Scott, Alice Jacobson, Lisa Dean, Sylvia Sudat, Angelica Obillo, Andrew Avins

Abstract

Background: Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial.

Methods/design: This study, set in Northern California, is a two-arm parallel-comparison single-blinded randomized controlled pilot trial with the goal of recruiting approximately 60 participants with moderate-to-severe episodic migraine. The feasibility outcomes include ability and time required to recruit, adherence to the MBSR treatment, and ability to measure outcomes using 31-day headache diaries and patient-reported questionnaire data. The active treatment arm consists of an 8-week community-based MBSR class plus usual care, and the wait-list control group is usual care. Recruitment is underway and expected to be complete by the end of 2018.

Discussion: To our knowledge, this is the first pragmatic trial in the U.S. of MBSR for migraine using community-based classes, and if it proves viable, we plan to conduct a fully powered trial to determine the effectiveness of the intervention for reducing headache days for moderate-to-severe episodic migraineurs.

Trial registration: Clinicaltrials.gov, NCT02824250 . Registered on 6 July 2016.

Keywords: Behavioral intervention; Feasibility; Headache; Migraine; Mindfulness; Mindfulness-based stress reduction (MBSR); Pain; Pilot; Pragmatic; RCT; Trial protocol.

Conflict of interest statement

Ethics approval and consent to participate

The Sutter and Kaiser IRBs approved the protocol for this study. As a condition of that approval, each participant is required to sign an informed consent form that has been approved and stamped by the Sutter IRB. Major protocol changes must be reported to and approved by both the National Center for Complementary and Integrative Health and the Sutter and Kaiser IRBs. To ensure there are proper safeguards to maintain participant safety and the integrity of the data, a DSMB is monitoring the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow diagram. MBSR Mindfulness-based stress reduction
Fig. 2
Fig. 2
SPIRIT figure. HIPAA Health Insurance Portability and Accountability Act, MBSR Mindfulness-based stress reduction

References

    1. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343–349. doi: 10.1212/01.wnl.0000252808.97649.21.
    1. Goldberg LD. The cost of migraine and its treatment. Am J Manag Care. 2005;11:S62–S67.
    1. Stovner L, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007;27:193–210. doi: 10.1111/j.1468-2982.2007.01288.x.
    1. Merikangas KR. Contributions of Epidemiology to Our Understanding of Migraine. Headache. 2013;53(2):230–246. doi: 10.1111/head.12038.
    1. Burch R, Rayhill M. New preventive treatments for migraine. BMJ. 2018;361:k2507. doi: 10.1136/bmj.k2507.
    1. Theeler BJ, Kenney K, Prokhorenko OA, Fideli US, Campbell W, Erickson JC. Headache triggers in the U.S. military. Headache. 2010;50(5):790–794. doi: 10.1111/j.1526-4610.2009.01571.x.
    1. Sauro KM, Becker WJ. The stress and migraine interaction. Headache. 2009;49(9):1378–1386. doi: 10.1111/j.1526-4610.2009.01486.x.
    1. Greeson J, Eisenlohr-Moul T. Mindfulness-Based Stress Reduction for Chronic Pain. Mindfulness-Based Treatment Approaches: Clinician’s Guide to Evidence Base and Applications. 2014. p. 269.
    1. Gotnick R, Chu P, Busschbach J, Benson H, Fricchione G, Standardised HM. Mindfulness-Based Interventions in Healthcare: An Overview of Systematic Reviews and Meta-Analyses of RCTs. PLoS One. 2015;10(4):1–17.
    1. Rosenzweig S, Greeson JM, Reibel DK, Green JS, Jasser SA, Beasley D. Mindfulness-based stress reduction for chronic pain conditions: variation in treatment outcomes and role of home meditation practice. J Psychomatic Res. 2010;68(1):29–36. doi: 10.1016/j.jpsychores.2009.03.010.
    1. Wells RE, Burch R, Paulsen RH, Wayne PM, Houle TT, Loder E. Meditation for migraines: a pilot randomized controlled trial. Headache. 2014;54(9):1484–1495. doi: 10.1111/head.12420.
    1. Lauche R, Cramer H, Paul A, Dobos GJ, Rampp T. Introducing integrative integrated migraine care (IIMC): a model and case presentation. Eur J Integr Med. 2012;4(1):e37–e40. doi: 10.1016/j.eujim.2011.11.005.
    1. Oberg EB, Rempe M, Bradley R. Self-directed mindfulness training and improvement in blood pressure, migraine frequency, and quality of life. Glob Adv Health Med. 2013;2(2):20–25. doi: 10.7453/gahmj.2013.006.
    1. Schmidt S., Simshäuser K., Aickin M., Lüking M., Schultz C., Kaube H. Mindfulness-based stress reduction is an effective intervention for patients suffering from migraine—Results from a controlled trial. European Journal of Integrative Medicine. 2010;2(4):196.
    1. Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, et al. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLOS ONE. 2016;11(3):e0150205. doi: 10.1371/journal.pone.0150205.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. Pressman A, Jacobson A, Eguilos R, Gelfand A, Huynh C, Hamilton L, et al. Prevalence of migraine in a diverse community-electronic methods for migraine ascertainment in a large integrated health plan. Cephalalgia. 2016;36(4):325–334. doi: 10.1177/0333102415590242.
    1. StataCorp . Stata Statistical Software: Release 14. College Station: StataCorp. LP; 2015.
    1. History of MBSR [Internet]. University of Massachusetts Medical School. 2016 [cited 2018 Sep 6]. Available from:
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Weinfurt, Cella. PROMIS Dynamic Tools to MEasure Health Outcomes from the Patient Perspective [Internet]. NIH; [cited 2015 Jun 1]. Available from:
    1. Odenkirchen J. NINDS Common Data Elements. Harmonizing Information. Streamlining Research. [Internet]. NIH; 2015 [cited 2015 Jun 1]. Available from:
    1. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4(5):353–365. doi: 10.2165/00019053-199304050-00006.
    1. Loeppke R, Hymel PA, Lofland JH, Pizzi LT, Konicki DL, Anstadt GW, et al. Health-related workplace productivity measurement: general and migraine-specific recommendations from the ACOEM Expert Panel. J Occup Environ Med. 2003;45(4):349–359. doi: 10.1097/01.jom.0000063619.37065.e2.
    1. Lane JD, Seskevich JE, Pieper CF. Brief meditation training can improve perceived stress and negative mood. Altern Ther Health Med. 2007;13(1):38–44.
    1. Marcus MT, Fine PM, Moeller FG, Khan MM, Pitts K, Swank PR, et al. Change in Stress Levels Following Mindfulness-based Stress Reduction in a Therapeutic Community. Addict Disord Treat. 2003;2(3):63–68. doi: 10.1097/00132576-200302030-00001.
    1. Brown KW, Ryan RM. The benefits of being present: Mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003;84:822–848. doi: 10.1037/0022-3514.84.4.822.
    1. Carlson LE, Brown KW. Validation of the Mindful Attention Awareness Scale in a cancer population. J Psychosom Res. 2005;58(1):29–33. doi: 10.1016/j.jpsychores.2004.04.366.
    1. Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63(5):484–489. doi: 10.1001/archpsyc.63.5.484.
    1. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45(5):626–629. doi: 10.1016/j.jpsychires.2010.10.008.
    1. Cowan RP. CAM in the Real World: You May Practice Evidence-Based Medicine, But Your Patients Don’t. Headache. 2014;54(6):1097–1102. doi: 10.1111/head.12364.
    1. Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, et al. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016;176(3):329–337. doi: 10.1001/jamainternmed.2015.8033.
    1. Zgierska AE, Burzinski CA, Cox J, Kloke J, Stegner A, Cook DB, et al. Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial. Pain Med. 2016;17(10):1865–1881. doi: 10.1093/pm/pnw006.
    1. Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, et al. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016;315(12):1240–1249. doi: 10.1001/jama.2016.2323.
    1. Van Gordon W, Shonin E, Dunn TJ, Garcia-Campayo J, Griffiths MD. Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial. Br J Health Psychol. 2017;22(1):186–206. doi: 10.1111/bjhp.12224.
    1. Cash E, Salmon P, Weissbecker I, Rebholz WN, Bayley-Veloso R, Zimmaro LA, et al. Mindfulness meditation alleviates fibromyalgia symptoms in women: results of a randomized clinical trial. Ann Behav Med. 2015;49(3):319–330. doi: 10.1007/s12160-014-9665-0.
    1. Avins AL, Cherkin DC, Sherman KJ, Goldberg H, Pressman A. Should we reconsider the routine use of placebo controls in clinical research? Trials. 2012;13(1) Available from: . [cited 2019 Jan 31].

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