PHILADELPHIA – , according to randomized clinical trial results.
“The fact that people can improve how they live their daily life even with the same amount of headache days and the same pain intensity is remarkable,” said study investigator Elizabeth K. Seng, PhD, associate professor of psychology at Yeshiva University and research associate professor of neurology at Albert Einstein College of Medicine, both in New York. “I think this gives us a little bit of a clue about when to use these kinds of treatments.”
Dr. Seng presented findings from the phase 2b pilot trial at the annual meeting of the American Headache Society.
To study the efficacy of mindfulness-based cognitive therapy for migraine, Dr. Seng and her research colleagues recruited participants with migraine in the New York City area between 2015 and 2018. In all, 60 patients were randomized to receive 8 weekly individual 75-minute mindfulness-based cognitive therapy for migraine sessions or 8 weeks on a wait list with treatment as usual.
Primary outcomes were Month 0 to Month 4 changes in perceived disability, measured using the Henry Ford Disability Inventory (HDI) and functional disability measured using the Migraine Disability Assessment Scale (MIDAS). Secondary outcomes included changes in headache days per 30 days and headache pain intensity.
Participants had a mean age of about 40 years, about 92% were women, and approximately half of the patients had chronic migraine. Participants had an average baseline HDI of 51.4, and 83.3% had MIDAS scores indicating severe disability. Patients averaged 10.4 headache attack days per month, and mean headache attack severity on a 0-10 scale was 6.2. Attrition did not significantly differ between the mindfulness-based cognitive therapy and control groups.
Patients who received mindfulness-based cognitive therapy for migraine experienced an approximately 15-point reduction on the HDI scale at 4 months, whereas wait-listed patients did not experience much of a change, Dr. Seng said. The difference between groups was statistically significant.
At 4 months, a smaller proportion of patients in the mindfulness-based cognitive therapy group had a MIDAS score of 21 or greater, but the difference between groups was not statistically significant. The data indicate a large effect that the study was underpowered to detect, Dr. Seng said.
A planned subgroup analysis found that mindfulness-based cognitive therapy produced changes in disability that were greater in patients with episodic migraine, compared with patients with chronic migraine. A reduction in MIDAS scores was statistically significant among patients with episodic migraine.
During the trial, one patient experienced increased headache frequency and intensity and changed their preventive treatment regimen, which investigators considered unrelated to mindfulness-based cognitive therapy. In addition, one patient experienced flooding – a vivid recollection of a traumatic event – which is an expected effect of meditation and relaxation therapy, Dr. Seng said. The patient completed the study and was satisfied with the mindfulness-based cognitive therapy training, she said.
“Preliminary evidence suggests that mindfulness-based cognitive therapy could be recommended to reduce headache-related disability in people with episodic migraine or people who have some kind of effective prevention on board, but they are still experiencing high levels of disability,” Dr. Seng said.
Although flooding may occur in patients with a trauma history who use meditation and relaxation, the techniques still may be useful, Dr. Seng said. “In the VA setting, we use meditation and relaxation all the time. But it helps to forewarn patients that they might experience distressful flooding and [to provide] techniques that they can use to reduce the impact of that.”