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).
Alice Pressman, Heather Law, Robert Stahl, Alex Scott, Alice Jacobson, Lisa Dean, Sylvia Sudat, Angelica Obillo, Andrew L Avins
Trials May 6, 2019 DOI: 10.1186/s13063-019-3355-y (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled pilot trial protocol Pilot study Peer reviewed |
|---|---|
| Sample size | 60 |
| Population | Adults with moderate-to-severe episodic migraine in Northern California |
| Intervention | Mindfulness-based stress reduction (MBSR) |
| Duration | 8-week MBSR intervention |
| Measures | 31-day headache diaries, patient-reported questionnaires |
| Topics | Meditation |
| Keywords | Behavioral intervention Feasibility Headache Migraine Pain Pilot Pragmatic Rct Trial protocol |
| Registration | NCT02824250 |
| Key findings | The protocol describes a pilot trial to assess the feasibility of MBSR for episodic migraine, including recruitment, adherence, and outcome measurement via 31-day headache diaries. The authors state that if the pilot proves viable, they plan a fully powered trial to determine whether MBSR reduces headache days. |
Abstract
Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based meditation intervention, is inexpensive, has no known side effects, and has demonstrated clinically meaningful effectiveness for several chronic-pain syndromes. In addition, MBSR has shown promising results for migraine therapy in a few small case studies and pilot studies. We present here the protocol for a two-arm randomized controlled pilot trial of MBSR for moderate-to-severe episodic migraine, which, if successful, will form the basis for a fully powered clinical trial. This study, set in Northern California, is a two-arm parallel-comparison single-blinded randomized controlled pilot trial with the goal of recruiting approximately 60 participants with moderate-to-severe episodic migraine. The feasibility outcomes include ability and time required to recruit, adherence to the MBSR treatment, and ability to measure outcomes using 31-day headache diaries and patient-reported questionnaire data. The active treatment arm consists of an 8-week community-based MBSR class plus usual care, and the wait-list control group is usual care. Recruitment is underway and expected to be complete by the end of 2018. To our knowledge, this is the first pragmatic trial in the U.S. of MBSR for migraine using community-based classes, and if it proves viable, we plan to conduct a fully powered trial to determine the effectiveness of the intervention for reducing headache days for moderate-to-severe episodic migraineurs. Clinicaltrials.gov, NCT02824250 . Registered on 6 July 2016.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 6
- Mindfulness in migraine: A narrative review Expert Review of Neurotherapeutics January 14, 2020
- Exploring Mechanisms, Methods, and Measurement in Mindfulness Research: A Scoping Review of Community-Based Interventions Mindfulness September 15, 2026
- Randomized controlled trial of neurofeedback mindfulness meditation as a practice for migraine management. Journal of Clinical Neuroscience December 1, 2025
- Part Of the Process, or Adverse Event? Considering the Benefits and Potential Risks of Mindfulness-based Interventions for Migraine. Current Pain and Headache Reports September 16, 2025
- Experiences of a Neurofeedback-Based Mindfulness Meditation Intervention for Migraine: Qualitative Study. JMIR neurotechnology 2025
and 1 more in the library
Cites 8
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- Standardised Mindfulness-Based Interventions in Healthcare: An Overview of Systematic Reviews and Meta-Analyses of RCTs PLoS One April 16, 2015
- Mindfulness Meditation and Cognitive Behavioral Therapy Intervention Reduces Pain Severity and Sensitivity in Opioid-Treated Chronic Low Back Pain: Pilot Findings from a Randomized Controlled Trial Pain Medicine March 10, 2016
- A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Internal Medicine March 1, 2016
- Meditation for migraines: a pilot randomized controlled trial. Headache: The Journal of Head and Face Pain October 2014
and 3 more in the library