FINAL REPORT: Efficacy of Behavioral Insomnia Treatment for Chronic Migraine: A Randomized Controlled Pilot Study

Published in Headache, Volume 56, Issue 2, February 2016

Summary

The large majority of individuals with chronic migraine also suffer from insomnia in the form of trouble falling or staying asleep. Given a large body of research confirming the long-term efficacy of behavioral insomnia interventions, the goal of this study was to pilot test a brief 3-session behavioral insomnia intervention (cognitive-behavioral treatment of insomnia, or CBTi) to determine if directly targeting chronic migraineurs’ sleep problems would reduce the frequency of their headaches, as well as to test the feasibility of the intervention. Thirty-one adults, ages 18-57, participated in this pilot study. The average monthly headache frequency for all participants was 21.5 headache days per month, and participants had severe or very severe disability related to their headaches.

Sixteen participants were randomly assigned to CBTi; 15 were randomly assigned to a control group focused on changing general lifestyle habits. Individuals in both groups showed a substantial reduction in headache frequency from baseline. Those receiving CBTi showed a 28% reduction in headache frequency at 2 weeks treatment ended and a 49% reduction at 6-week follow-up. Those in the control group showed a 36% reduction in headache frequency 2 weeks after treatment, which dropped to 25% reduction at 6-week follow-up. Both groups thus showed a large reduction in headache frequency, but the effects of the sleep intervention were more enduring. Improvements in sleep variables were associated with reductions in headache. Adherence was high and CBTi was perceived as a credible treatment by participants; CBTi had fewer dropouts than the control group.

Hypothesis vs. Findings

The findings partially supported our hypothesis that those in the Sleep Management group would improve more than those in the control group. While the reductions in headache frequency did not differ between groups 2 weeks after treatment, at 6-week followup the odds of experiencing headache were 60% lower for those receiving CBTi than those receiving the control treatment. CBTi produced larger increases than control treatment in total sleep time and sleep efficiency (time asleep:time in bed). Patients rated each intervention as equally credible, which may explain the high response rate of the control group.

Unanswered Questions

Future research will need to investigate the long-term effects of CBTi for migraine, in order to assess how long after treatment the positive effects endure. Identifying a truly inert therapy control condition remains a challenge to behavioral interventions, and more research is needed to understand factors that contribute to high response rates among control treatments such as the one used in this study. Studies seeking to build on this research could use larger samples and a longer follow-up period.

What This Research Means to You

Funding provided by the Migraine Research Foundation helped demonstrate the promise of a brief behavioral sleep intervention for migraine patients, suggesting that directly treating co-occurring insomnia may improve migraine itself. The intervention was easy to deliver, credible to patients, and produced substantial reductions in headache, suggesting that it could be incorporated into management of chronic migraine patients pending further study.