Project Summary

This project is ongoing and does not have results.

The Patient-Centered Outcomes Research Institute (PCORI) is partnering with the Agency for Healthcare Research and Quality (AHRQ) to conduct a systematic review on behavioral interventions for migraine prevention. The American Headache Society will partner with PCORI in this endeavor with the hope that the results of the update will provide valuable insight for future guidelines for the management of migraine.

Migraine is a common condition, affecting 1 in 6 Americans. Migraines are often painful and debilitating, accounting for over 4 million emergency department visits in 2016 alone. The prevalence of the condition is nearly double in women compared to men, with 21% of women and 11% of men in the United States suffering from migraine. Additionally, migraine is more common among adults of low socioeconomic status. For children and adolescents, the prevalence of migraine ranges from 8% to 24%, with more than one-quarter of youth who suffer from migraine reporting moderate to severe disability, impacting school attendance and performance, relationships, and mental wellbeing.

Preventive therapies for episodic migraine (fewer than 15 migraine days per month) and chronic migraine (15 or more migraine days per month) aim to reduce the number and severity of migraines and can improve quality of life for patients. There are numerous options for migraine prevention, both pharmacologic and nonpharmacologic, which can make selecting a therapy difficult for physicians and patients.

Several pharmacologic interventions have shown efficacy for migraine prevention in adults, however, many of these first-line medications were initially developed to treat other health conditions, such as depression or high blood pressure, and carry risks of side effects that may not be tolerable for migraine patients. Moreover, many pharmacologic interventions provide only very modest reductions in migraine frequency. For children and adolescents, there are limited pharmacologic options due to age and a lack of clinical trials supporting the medications’ use in these age groups. The limited available evidence suggests that standard pharmacologic agents used for migraine prevention in children and adolescents may be no more beneficial than placebo while also conveying significant risk for adverse side effects.

Nonpharmacologic preventive therapies have demonstrated efficacy for reducing migraine frequency, reducing pain intensity, and improving overall well-being for individuals with migraine across the lifespan. Behavioral interventions for migraine prevention represent an important group of nonpharmacologic preventive therapies with fewer side effects relative to pharmacologic therapies. Behavioral interventions include progressive muscle relaxation, biofeedback, behavioral training, cognitive behavioral interventions, acceptance and commitment therapy, mindfulness-based interventions, and more, many of which have evidence of benefit.

Current guidance from headache societies on behavioral interventions for migraine prevention is limited and requires updating. The most recent clinical practice guidelines from headache societies date to 2012 and do not include many new therapies employed today. Although more recent consensus statements have been issued— including a series annually issued by the American Headache Society from 2018-2022, on integrating new pharmacologic and nonpharmacologic migraine therapies into clinical practice, and in 2019 by the American Academy of Family Physicians, which broadly covered pharmacologic and nonpharmacologic migraine prevention, they were not based on a systematic review of the evidence and included limited attention to the unique treatment needs of children and adolescents relative to adults.

A new systematic review of the evidence may be timely and necessary for guideline updates. A recent topic brief and rapid scoping review of the literature suggested existing systematic reviews on behavioral therapies were dated. The most recent reviews (for adults) were published several years ago (2018/2019), and covered psychological interventions, biofeedback, cognitive behavioral therapy, and progressive muscle relaxation for migraine prevention in adults, but did not comprehensively assess all preventive behavioral therapy options. Although a recently published, network meta-analysis assessed nonpharmacologic interventions for migraine in children and adolescents, the literature search was completed in 2019. New evidence has accumulated since the time of these systematic reviews, with several recent trials of behavioral therapies for migraine prevention not yet summarized in an evidence synthesis product. Given the lack of a recent and comprehensive systematic review and in the face of accumulating evidence, this proposed review will aim to inform a guideline on behavioral interventions for migraine prevention in adults, adolescents, and children and inform decision-making for physicians, patients, and caregivers.

Draft Key Questions

  1. What are the benefits and harms of behavioral interventions, either alone or in combination with other preventive strategies (including pharmacologic therapy), for migraine prevention compared to inactive control for children and adults?
    1. What are the benefits and harms of behavioral interventions delivered via telehealth and digital health (e/mhealth) technology compared to inactive control?
  2. What is the comparative effectiveness and harms of a behavioral intervention for migraine prevention compared to either a) a pharmacologic preventive agent or b) another behavioral intervention for children and adults? 
    1. What is the comparative effectiveness and harms of behavioral interventions delivered via telehealth and digital health (e/mhealth) technology compared to a) pharmacologic prevention or b) other behavioral interventions?  
  3. For multicomponent or combined behavioral interventions, what are the effects of individual behavioral intervention components?
  4. What are the benefits and harms of non-headache focused behavioral interventions (e.g., CBT for insomnia, CBT for depression/anxiety, parent training) for improving headache in children and adults with migraine?
  5. For key questions 1-4, how do the findings vary by baseline biopsychosocial factors (e.g., sex, socioeconomic status, co-occurring mental health conditions)?

Contextual Questions

  1. What evidence is available on the benefits of behavioral treatments for children and adults with migraine that include treatment components targeting caregiving behaviors and caregiver distress (caregivers could include parents, spouses, and other key support people)?
  2. What are patient and provider perceptions of the benefits, harms, and barriers to engaging with behavioral treatments for migraine in children and adults?

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Project Information

Agency for Healthcare Research and Quality (AHRQ)

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Last updated: February 2, 2024