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Mindfulness and Migraine Research Study (M&M)

This study is currently recruiting participants.
Verified April 2017 by California Pacific Medical Center Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02824250
First Posted: July 6, 2016
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Kaiser Permanente
Sutter Health
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
California Pacific Medical Center Research Institute
  Purpose
The primary aim of this study is to conduct a randomized controlled feasibility trial of MBSR for patients with moderate-to- severe migraine headache.

Condition Intervention
Migraine Chronic Pain Behavioral: MBSR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness and Migraine: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • recruitment rate [ Time Frame: 18 months post recruitment start ]
    number recruited per month


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Actual Study Start Date: March 9, 2017
Estimated Study Completion Date: May 31, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBSR + Usual Care
8-week standard Mindfulness-Based Stress Reduction (MBSR) course + standard of care
Behavioral: MBSR
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

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 4-14 headaches per month and randomize them to a full 9-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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Heather Law, MA 925-239-6726 lawh@sutterhealth.org
Contact: Alice Pressman, PhD 925-287-4018 pressmar@sutterhealth.org

Locations
United States, California
Palo Alto Medical Foundation Research Institute Recruiting
Palo Alto, California, United States, 94301
Contact: Heather Law, MA    925-239-6726    lawh@sutterhealth.org   
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Kaiser Permanente
Sutter Health
National Center for Complementary and Integrative Health (NCCIH)
  More Information

Responsible Party: California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT02824250     History of Changes
Other Study ID Numbers: 897613
1R01AT00908101 ( Other Grant/Funding Number: National Center for Complementary and Integrative Health )
First Submitted: June 7, 2016
First Posted: July 6, 2016
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by California Pacific Medical Center Research Institute:
Migraine
Mindfulness
MBSR

Additional relevant MeSH terms:
Migraine Disorders
Chronic Pain
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms