Mindfulness and Migraine Research Study

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to conduct a randomized controlled feasibility trial of MBSR for patients with moderate-to- severe migraine headache.

Detailed Description
-----------------
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 4-20 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. 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.

Official Title
-----------------
Mindfulness and Migraine: A Randomized Controlled Trial

Conditions
-----------------
Migraine, Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: MBSR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older 4-20 headaches per month (based on run-in headache diary) Exclusion Criteria: No meditation or MBSR during the past 6 months 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR + Usual Care<br>8-week standard Mindfulness-Based Stress Reduction (MBSR) course + standard of care | Behavioral: MBSR<br>* Mindfulness-Based Stress Reduction (MBSR) is an 8-week classroom based program of mindfulness meditation and gentle yoga.<br>|
| No Intervention: Usual Care<br>Standard of care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recruitment rate | number recruited per month | 18 months post recruitment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment adherence | proportion of classes attended | 18 months post recruitment start | 
| diary completion | proportion of days completed for each diary type | 2 years post recruitment start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Mindfulness, MBSR