Mindfulness and Migraine Research Study

Migraine, one of the most common neurological disorders in the U.S., is ranked among the top
20 causes of disability worldwide. Migraine is currently one of the leading causes of disease
burden for women aged 15-44 years and affects an estimated 11% of the adult population
globally, with a strong female predominance. Current approaches to therapy are primarily
medication-based but are limited by often-inadequate effectiveness, high costs for many
migraine-specific medications, and common side effects. In addition, there likely exist
subtypes of migraine that may affect the likelihood of response to treatment, but these have
been poorly investigated to-date. Furthermore, many patients are interested in exploring
alternatives to pharmacological therapy for this functional disorder.

Mindfulness-based stress reduction (MBSR), a meditation-based intervention developed by
Kabat-Zinn at the University of Massachusetts, has been increasingly shown to be effective
for many patients with a variety of functional disorders. Recent small pilot studies suggest
that MBSR may also provide an important benefit as an adjunctive therapy for patients with
migraine headaches.

In preparation for a fully powered randomized controlled clinical trial of MBSR for patients
with moderate-to-severe migraine headache, the investigators propose a detailed
pilot/feasibility study to develop and test the clinical research methods required for a
successful Phase III trial. The investigators will first identify a large number of
migraineurs in the Northern California-based Sutter Health system using analytic tools
previously developed by the group. Next, using latent class analysis, the investigators will
identify subgroups of migraine patients defined by comorbidities. The investigators will then
enroll 60 patients with a pattern of 4-14 headaches per month and randomize them to a full
8-week MBSR intervention with usual care or usual care alone, with follow-up at 4 months. The
primary clinical outcome is change in headache frequency at 4 months, with several secondary
outcomes, including assessments of pain, quality of life, and functional status.

As a feasibility study, the primary emphases of the trial are to demonstrate the
investigators' ability to recruit and retain participants, to test whether their proposed
enrollment criteria identify the appropriate patient population, to assess participants'
levels of adherence to all aspects of the protocol, and to determine optimal methods for data
collection. The investigators will compare two different smartphone-based applications for
collecting headache-diary information and will test the logistics for employing interim
Bayesian monitoring. No tests of clinical effectiveness will be performed.

The results of this feasibility study will provide invaluable information for the study
investigators in development of methods to ensure a highly successful and informative Phase
III trial of a promising MBSR intervention for this common and distressing medical condition.

Inclusion Criteria:

- Age 18 years or older

- 4-14 headaches per month (based on run-in headache diary)

Exclusion Criteria:

- No meditation or MBSR during the past 6 months

- Chronic migraine (>14 migraine episodes per month)

- Cognitively or emotionally impaired as judged by a research physician prior to
randomization

- Pregnant

- Lack of English language skills

- No new migraine medication in past month

- Incomplete headache diary during run-in period