Mindfulness and Migraine Research Study (M&M)

• ClinicalTrials.gov Identifier: NCT02824250
• Recruitment Status: Active, not recruiting
• First Posted: July 6, 2016
• Last Update Posted: July 23, 2019
• Sponsor: California Pacific Medical Center Research Institute
• Collaborators: Kaiser Permanente; Sutter Health; National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): California Pacific Medical Center Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Migraine; Chronic Pain	Behavioral: MBSR	Not Applicable

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 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mindfulness and Migraine: A Randomized Controlled Trial
• Actual Study Start Date: March 9, 2017
• Actual Primary Completion Date: February 7, 2019
• Estimated Study Completion Date: November 30, 2019

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. recruitment rate [ Time Frame: 18 months post recruitment start ]
   number recruited per month

Secondary Outcome Measures :

1. treatment adherence [ Time Frame: 18 months post recruitment start ]
   proportion of classes attended
2. diary completion [ Time Frame: 2 years post recruitment start ]
   proportion of days completed for each diary type

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

United States, California

Palo Alto Medical Foundation Research Institute

Palo Alto, California, United States, 94301

Sponsors and Collaborators

California Pacific Medical Center Research Institute

Kaiser Permanente

Sutter Health

National Center for Complementary and Integrative Health (NCCIH)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pressman A, Law H, Stahl R, Scott A, Jacobson A, Dean L, Sudat S, Obillo A, Avins A. 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). Trials. 2019 May 6;20(1):257. doi: 10.1186/s13063-019-3355-y.

• 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 Posted: July 6, 2016
• Last Update Posted: July 23, 2019
• Last Verified: July 2019

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