Mindfulness and Migraine Research Study (M&M)
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|ClinicalTrials.gov Identifier: NCT02824250|
Recruitment Status : Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine Chronic Pain||Behavioral: MBSR||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Mindfulness and Migraine: A Randomized Controlled Trial|
|Actual Study Start Date :||March 9, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||May 31, 2019|
Experimental: MBSR + Usual Care
8-week standard Mindfulness-Based Stress Reduction (MBSR) course + standard of care
Mindfulness-Based Stress Reduction (MBSR) is an 8-week classroom based program of mindfulness meditation and gentle yoga.
No Intervention: Usual Care
Standard of care
- recruitment rate [ Time Frame: 18 months post recruitment start ]number recruited per month
- treatment adherence [ Time Frame: 18 months post recruitment start ]proportion of classes attended
- diary completion [ Time Frame: 2 years post recruitment start ]proportion of days completed for each diary type
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824250
|United States, California|
|Palo Alto Medical Foundation Research Institute|
|Palo Alto, California, United States, 94301|