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 U.S. suffering from migraine. Additionally, migraine is more common among adults of low socioeconomic status.1 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.2
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.3,4
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.3 Moreover, many pharmacologic interventions provide only very modest reductions in migraine frequency.3 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.5 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.6
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.4 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.7
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.8 Although more recent consensus statements have been issued- a series annually issued by the AHS 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.9-12
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.4 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.13-15 Although a recently published network meta-analysis assessed nonpharmacologic interventions for migraine in children and adolescents, the literature search was completed in 2019.16 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.4 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
KQ1. 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?
a. What are the benefits and harms of behavioral interventions delivered via telehealth and digital health (e/mhealth) technology compared to inactive control?
KQ2. 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?
a. 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?
KQ3. For multicomponent or combined behavioral interventions, what are the effects of individual behavioral intervention components?
KQ4. 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?
KQ5. For key questions 1-4, how do the findings vary by baseline biopsychosocial factors (e.g., sex, socioeconomic status, co-occurring mental health conditions)?
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)?
What are patient and provider perceptions of the benefits, harms, and barriers to engaging with behavioral treatments for migraine in children and adults?
Table 1. PICOTS for Behavioral Interventions for Migraine Prevention (BIMP)
|Inclusion Criteria||Exclusion Criteria|
Adults (over 21 years of age), adolescents (10-21 years of age), and children (under 10 years of age) with episodic or chronic migraine.
KQ 1 – KQ 3. Behavioral interventions targeted to prevent migraine, including:
KQ 1a & KQ 2a. Interventions for KQ 1 and KQ 2 delivered via telehealth and digital health (e/mhealth) technology.
KQ 4. Non-headache focused behavioral interventions (e.g., cognitive behavioral therapy for insomnia or depression/anxiety, sleep hygiene, parent/caregiver operant training) targeting both non-headache primary outcomes and headache outcomes.
|Complementary and integrative preventive therapies included in the AAN’s in-progress clinical practice guideline.a|
KQ1, KQ 3 & KQ4. Inactive control
KQ2 - KQ4. Different behavioral intervention
KQ2 - KQ4. Pharmacologic intervention
|KQ 1 – KQ 4.
KQ4. For interventions targeting non-headache outcomes (e.g., sleep hygiene, CBT for insomnia): Sleep quality, depressive symptoms, anxiety symptoms.
For pediatric trials: Parenting/caregiving behaviors, parent/caregiver anxiety, parent/caregiver depression, parent/caregiver distress.
Minimum 8-week follow-up duration.
Randomized controlled trials.
|Fewer than 10 participants per treatment arm.|
MIDAS = Migraine Disability Assessment. HIT-6 = Headache Impact Test.
Draft Analytic Framework:
- Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: Updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. 2021 Jan;61(1):60-68. doi: 10.1111/head.14024. Epub 2020 Dec 21. PMID: 33349955.
- Patniyot I, Qubty W. Short-term Treatment of Migraine in Children and Adolescents. JAMA Pediatr. 2020 Aug 1;174(8):789-790. doi: 10.1001/jamapediatrics.2020.1422. PMID: 32568383.
- Tsou A, Rouse B, Bloschichak a, et al. Drugs and Devices for Migraine Prevention: Interactive Evidence Maps. Patient-Centered Outcomes Research Institute; February 2021. Prepared by ECRI under Contract No. IDIQ-TO#12-ECRI-SCI-EVIDENCEMAP-2019- 07-15.
- Tsou A, Datko M, Oristaglio J. Topic Brief: Nonpharmacologic Interventions for Migraine Prevention. Patient-Centered Outcomes Research Institute; August 2021. Prepared by ECRI under Contract No. IDIQ-TO#15-ECRI-ENG-EVIDENCEMAP-04-01-2021.
- Rao R, Hershey AD. An update on acute and preventive treatments for migraine in children and adolescents. Expert Rev Neurother. 2020 Oct;20(10):1017-1027. doi: 10.1080/14737175.2020.1797493. Epub 2020 Jul 28. PMID: 32700569.
- Powers SW, Coffey CS, Chamberlin LA, Ecklund DJ, Klingner EA, Yankey JW, Korbee LL, Porter LL, Hershey AD; CHAMP Investigators. Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017 Jan 12;376(2):115-124. doi: 10.1056/NEJMoa1610384. Epub 2016 Oct 27. PMID: 27788026; PMCID: PMC5226887.
- The primary care management of headache work group. VA/DoD clinical practice guideline for the primary care management of headache (PDF, 3 MB), version 1.0. Washington (DC): Department of Veterans Affairs, Department of Defense; 2020. 150 p.
- Holland S, Silberstein SD, Freitag F, Dodick DW, Argoff C, Ashman E; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012 Apr 24;78(17):1346-53. doi: 10.1212/WNL.0b013e3182535d0c. PMID: 22529203; PMCID: PMC3335449.
- American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59(1):1-18. doi.org/10.1111/head.13456.
- Burch RC, Ailani J, Robbins MS. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2022 Jan;62(1):111-112. doi: 10.1111/head.14245. Epub 2021 Dec 7. PMID: 34873692.
- Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039. doi: 10.1111/head.14153. Epub 2021 Jun 23. PMID: 34160823.
- Ha H, Gonzalez A. Migraine headache prophylaxis. Am Fam Physician. 2019;99(1):17-24.
- Sharpe L, Dudeney J, Williams ACC, Nicholas M, McPhee I, Baillie A, Welgampola M, McGuire B. Psychological therapies for the prevention of migraine in adults. Cochrane Database Syst Rev. 2019 Jul 2;7(7):CD012295. doi: 10.1002/14651858.CD012295.pub2. PMID: 31264211; PMCID: PMC6603250.
- Lee HJ, Lee JH, Cho EY, Kim SM, Yoon S. Efficacy of psychological treatment for headache disorder: a systematic review and meta-analysis. J Headache Pain. 2019 Feb 14;20(1):17. doi: 10.1186/s10194-019-0965-4. PMID: 30764752; PMCID: PMC6734438.
- Seo E, Hong E, Choi J, Kim Y, Brandt C, Im S. Effectiveness of autogenic training on headache: A systematic review. Complement Ther Med. 2018 Aug;39:62-67. doi: 10.1016/j.ctim.2018.05.005. Epub 2018 May 22. PMID: 30012394.
- Koechlin H, Kossowsky J, Lam TL, Barthel J, Gaab J, Berde CB, Schwarzer G, Linde K, Meissner K, Locher C. Nonpharmacological Interventions for Pediatric Migraine: A Network Meta-analysis. Pediatrics. 2021 Apr;147(4):e20194107. doi: 10.1542/peds.2019-4107. Epub 2021 Mar 9. PMID: 33688031.