Abstract and Introduction
Objective Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines.
Background Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines.
Methods We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up.
Results MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [−4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (−1.3 points/headache on 0–10 scale, [−2.3, 0.09], P = .053) and shorter (−2.9 hours/headache, [−4.6, −0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (−12.6, [−22.0, −1.0], P = .017 and −4.8, [−11.0, −1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P = .035 and 13.1 [3.0, 26.0], P = .035 respectively).
Conclusions MBSR is safe and feasible for adults with migraines. Although the small sample size of this pilot trial did not provide power to detect statistically significant changes in migraine frequency or severity, secondary outcomes demonstrated this intervention had a beneficial effect on headache duration, disability, self-efficacy, and mindfulness. Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines. This study was prospectively registered (ClinicalTrials.gov identifier NCT01545466).
Traditionally, medications are first-line treatment for migraine therapy. However, only about half of migraineurs have clinically meaningful responses to preventive drug treatments, more than 10% discontinue due to adverse events, and half report dissatisfaction with their current treatment strategies. When preventive treatments are ineffective, migraineurs may overuse symptomatic relief medications with a consequent worsening of their headache burden. Excessive use of abortive medications can cause the challenging and often refractory condition of medication overuse headache (MOH). These shortcomings of existing treatment options substantiate the great need for additional migraine treatment strategies.
Non-pharmacological options are believed to have few serious side effects, can be used concurrently with medications or when medication use must be limited or avoided due to side effects or contraindications, and reduce overall medication reliance and the possibility of MOH. Such therapies may be more congruent with patients' beliefs about health and life, can be taken concurrently with pharmacological therapies, and may have therapeutic effects on other factors contributing to headache burden such as stress or anxiety. Stress is widely believed to be a significant trigger for headaches.[5–10] The US Headache Consortium's treatment guidelines for prevention of migraines recommends the behavioral interventions of electromyographic biofeedback, relaxation training, thermal biofeedback combined with relaxation training, and cognitive behavioral therapy with Grade A evidence (based on evidence from 39 controlled trials).
In addition to these evidence-based behavioral interventions, many patients are using less-well researched non-pharmacological options such as complementary and alternative medicine (CAM) modalities in the treatment of headache. Approximately half of US adults with migraines report using CAM, especially mind/body therapies such as meditation and yoga. Many view CAM therapies as more helpful than conventional headache treatment. Both the evidenced-based behavioral interventions and CAM interventions may have many similar active ingredients (such as relaxation and stress management), and mindfulness meditation has the distinct purpose of teaching individuals how to maintain focus on a stimulus while simultaneously allowing intruding thoughts/feelings to be acknowledged but not judged. Mindfulness-based stress reduction (MBSR) is a mind/body intervention that follows a standardized 8-week protocol involving group instruction by certified instructors. It teaches mindfulness meditation and yoga, and daily assignments are used to build each participant's mindfulness practice. MBSR research has demonstrated measurable neurological changes post-intervention.[16–18] In addition, mindfulness meditation has been shown to differentially impact other non-headache-related outcomes and neurological changes compared to relaxation training, stress management training, and cognitive behavioral therapy.[19–22] Despite the high prevalence of use of such CAM therapies in the general population and in those with headaches and the distinct impact of such therapies compared to previously researched behavioral interventions for headaches, to our knowledge no studies have been done to evaluate the effectiveness of a standardized CAM intervention for headaches.
Although there is evidence supporting mindfulness-based interventions for chronic pain,[23–25] and evidence showing that meditation significantly reduces pain in experimental settings,[26,27] and various forms of meditation may impact migraines, there are no studies evaluating mindfulness meditation specifically for migraines. If MBSR, a standardized mind/body intervention, offers benefits to migraine patients, it could be easily used and recommended in the treatment of migraines. Once patients are trained in the techniques, they can use MBSR anywhere and at any time, potentially to prevent as well as abort headaches.
For these reasons, we conducted a randomized controlled study with the objective of assessing the safety, feasibility, and effect of MBSR in migraineurs vs usual care. Our hypotheses were: (1) MBSR is feasible and safe in migraineurs; (2) MBSR will decrease migraine frequency, severity, and duration; and (3) the MBSR group will demonstrate trends toward improved quality of life and self-efficacy and less depression, anxiety, and migraine-related disability.
Headache. 2014;54(9):1484-1495. © 2014 Blackwell Publishing