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Received: 21 February 2024 | Accepted: 6 January 2025

DOI: 10.1111/head.14914

REVIEW ARTICLE

Behavioral interventions for migraine prevention: A systematic

review and meta-analysis

Jonathan R. Treadwell PhD1 | Amy Y. Tsou MD1 | Benjamin Rouse MS1 |

1
ECRI, Plymouth Meeting, Pennsylvania,
USA Abstract
Objectives/Background: This study was undertaken to synthesize evidence on the
2
Pacific Northwest Evidence-Based
Practice Center, Portland, Oregon, USA
3
benefits and harms of behavioral interventions for migraine prevention in children
Penn Medicine Center for Evidence-Based
Practice, Philadelphia, Pennsylvania, USA and adults. The efficacy and safety of behavioral interventions for migraine preven-
4
Department of Neurology, Albert tion have not been tested in recent systematic reviews.
Einstein College of Medicine, New York,
Methods: An expert panel including clinical psychologists, neurologists, primary
New York, USA
5
Department of Pediatrics, University of care physicians, researchers, funders, individuals with migraine, and their caregiv-
Cincinnati College of Medicine, Cincinnati, ers informed the scope and methods. We searched MEDLINE, Embase, PsycINFO,
Ohio, USA
6 PubMed, the Cochrane Database of Systematic Reviews, clinicaltrials.gov, and gray
Headache Center, Cincinnati Children's
Hospital, Cincinnati, Ohio, USA literature for English-language randomized trials (January 1, 1975 to August 24, 2023)
7
Division of Behavioral Medicine and of behavioral interventions for preventing migraine attacks. Primary outcomes were
Clinical Psychology, Cincinnati Children's
Hospital, Cincinnati, Ohio, USA
migraine/headache frequency, migraine disability, and migraine-related quality of life.
8
Department of Neurology, NYU Langone One reviewer extracted data and rated the risk of bias, and a second verified data for
Health, New York, New York, USA completeness and accuracy. Data were synthesized with meta-analysis when deemed
9
Department of Population Health, NYU
appropriate, and we rated the strength of evidence (SOE) using established methods.
Langone Health, New York, New York, USA
10
Children's Hospital of Philadelphia Results: For adults, we included 50 trials (77 publications, N = 6024 adults). Most in-
and Perelman School of Medicine at the terventions were multicomponent (e.g., cognitive behavioral therapy [CBT], biofeed-
University of Pennsylvania, Philadelphia,
Pennsylvania, USA back, relaxation training, mindfulness-based therapies, and/or education). Most trials
11
Division of Hospital Medicine, were at high risk of bias, primarily due to possible measurement bias and incomplete
University of Pennsylvania, Philadelphia,
data. For adults, we found that any of three components (CBT, relaxation training,
Pennsylvania, USA
mindfulness-based therapies) may reduce migraine/headache attack frequency (SOE:
Correspondence
low). Education alone that targets behavior may improve migraine-related disability
Jonathan R. Treadwell, ECRI, Plymouth
Meeting, Pennsylvania, USA. (SOE: low). For three other interventions (biofeedback, acceptance and commitment
Email: [email protected]
therapy, and hypnotherapy), evidence was insufficient to permit conclusions. We also
Funding information found that mindfulness-based therapies may reduce migraine disability more than
Agency for Healthcare Research
education, and relaxation + education may improve migraine-related quality of life
and Quality, Grant/Award Number:

Abbreviations: ACT, acceptance and commitment therapy; AHRQ, Agency for Healthcare Research and Quality; CBT, cognitive behavioral therapy; CI, confidence interval; HIT-6 ,
Headache Impact Test-6; MBCT, mindfulness-based cognitive therapy; MBSR, mindfulness-based stress reduction; MID, minimal important difference; MIDAS, Migraine Disability
Assessment; MSQ, Migraine-Specific Quality of Life Questionnaire v2.1; PCORI, Patient-Centered Outcomes Research Institute; QoL, quality of life; SMD, standardized mean
difference; SOE, strength of evidence; TEP, Technical Expert Panel.

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in
any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2025 The Author(s). Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.

668 | wileyonlinelibrary.com/journal/head wileyonlinelibrary.com/journal/head Headache. 2025;65:668–694.

15264610, 2025, 4, Downloaded from https://headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14914 by Nat Prov Indonesia, Wiley Online Library on [13/08/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
HEADACHE 669

75Q80120D00002/Task Order
75Q80122F32006; PCORI, Grant/Award more than propranolol (SOE: low). For children/adolescents, we included 13 trials (16
Number: 2023-SR-03
publications, N = 1444 children), but the evidence was only sufficient to conclude that
CBT + biofeedback + relaxation training may reduce migraine attack frequency and
disability more than education alone (SOE: low).
Conclusion: Results suggest that for adults, CBT, relaxation training, and mindfulness-
based therapies may each reduce the frequency of migraine/headache attacks, and
education alone may reduce disability. For children/adolescents, CBT + biofeedback
+ relaxation training may reduce migraine attack frequency and disability more than
education alone. Evidence consisted primarily of underpowered trials of multicompo-
nent interventions compared with various types of control groups. Limitations include
semantic inconsistencies in the literature since 1975, differential usage of treatment
components, expectation effects for subjectively reported outcomes, incomplete
data, and unclear dosing effects. Future research should enroll children and adoles-
cents, standardize intervention components when possible to improve reproduc-
ibility, consider smart study designs and personalized therapies based on individual
characteristics, use comparison groups that control for expectation, which is a known
challenge in behavioral trials, enroll and retain larger samples, study emerging digital
and telehealth modes of care delivery, improve the completeness of data collection,
and establish or update clinical trial conduct and reporting guidelines that are appro-
priate for the conduct of studies of behavioral therapies.
Plain Language Summary: Behavioral interventions for migraine prevention are an im-
portant alternative to medications for both children and adults. To optimize decision-
making by patients and providers, we conducted a comprehensive systematic review
and meta-analysis of 63 randomized trials published since 1978. Due to methodo-
logical differences between studies, incomplete data, and unclear dosing effects, the
quality of the reviewed evidence was insufficient to permit conclusions; however,
some behavioral treatments appear to offer benefits in migraine reduction, and ad-
ditional research on these interventions in adult and pediatric populations is needed.

KEYWORDS
cognitive–behavioral therapy, headache, migraine, mindfulness, relaxation

I NTRO D U C TI O N such as mindfulness-based therapies (mindfulness-based cognitive

therapy [MBCT] and mindfulness-based stress reduction [MBSR]),2
One in six Americans has migraine, a chronic disease that globally and the pediatric headache preventive guidelines were limited to
stands as the second leading cause of disability. Migraine often im- studies that included pharmacologic agents.3 Consensus statements
pacts individuals during crucial periods of their lives, including years from the American Headache Society and American Academy of
of education, career progression, and child-rearing.1 Preventative Family Physicians on nonpharmacologic migraine prevention were not
migraine interventions aim to decrease the frequency, severity, and based on earlier systematic evidence reviews and did not address the
negative life impact of migraine attacks. Behavioral interventions specific treatment needs of children and adolescents.4–7 Recent liter-
may be used for migraine prevention as standalone therapies or ad- ature reviews indicate that existing systematic reviews on behavioral
junctive treatments to pharmacologic or other nonpharmacologic therapies may need to be updated.8 The most recent reviews, pub-
interventions. Behavioral therapies may be particularly attractive lished in 2018 and 2019, examined biofeedback, CBT, and progressive
for individuals seeking to avoid pharmacologic therapies due to side muscle relaxation (a form of relaxation training) for adult migraine
effects or personal preference. prevention, but did not evaluate all preventive behavioral therapy op-
The latest adult clinical practice guidelines from 2012 overlook be- tions.9–11 Two recent reviews focused on pain prevention in children
havioral therapies that have been more recently applied to migraine, and adolescents broadly, without specific emphasis on migraine.12,13
|

To address these evidence gaps and support the potential de- screening of both abstracts and full-text articles (in DistillerSR),
velopment of an evidence-based clinical practice guideline, we per- with discrepancies resolved by discussion between those disagree-
formed a systematic review. We defined behavioral interventions as ing (we did not compute interrater reliability). Trials had to report
nonpharmacologic strategies intended to modify behavior and/or data on at least one of three primary outcomes (attack frequency,
ways of thinking for adults, adolescents, and children with migraine. migraine disability, or migraine-specific quality of life [QoL]). This
This systematic review addressed the (1) effectiveness, (2) compar- article describes only these three outcomes; see the full report for
ative effectiveness, (3) contribution of specific behavioral compo- other outcomes (https://effectivehealthc are.ahrq.gov/produc ts/
nents, (4) effectiveness of non-migraine-focused interventions, (5) behavioral-interventions-migraine-prevention/research). If a trial
associations with patient factors, and (6) delivery via telehealth. This reported multiple metrics of migraine/headache attack frequency
article only summarizes the first three areas listed above; additional (e.g., both migraine days per month and migraine attacks per
findings are available in the full report (https://effectivehealthcare. month), we selected an outcome using the following order of prior-
ahrq.gov/produc ts/behavioral-interventions-migraine-prevention/ ity: (1) migraine days per month, (2) headache days per month, (3)
research). migraine attacks per month, (4) headache attacks per month, and
(5) percentage of patients experiencing a 50% or more reduction in
one of the metrics above. Due to resource constraints, we did not
M E TH O D S attempt to contact study authors for missing data or methodology
information.
We followed methods outlined in the Agency for Healthcare
Research and Quality (AHRQ) Methods Guide for Effectiveness and
Comparative Effectiveness Reviews.14 We recruited six key inform- Intervention categorization
ants to refine the topic and provide input on the scope. A seven-
member Technical Expert Panel (TEP) provided input on the protocol. Preventative behavioral interventions can have one component or
The key informants and TEP included clinical psychologists, adult and multiple components. To categorize interventions, first, we con-
pediatric neurologists, primary care physicians, researchers, funders, sidered trial descriptions of interventions, irrespective of how trial
pediatric and adult patients with migraine, and their caregiver rep- authors named their intervention(s). Second, any intervention men-
resentatives. The protocol was posted online for public comment tioned in the trial was considered part of the intervention, regardless
(www.effectivehealthcare.ahrq.gov) from July 19, 2022, to August 9, of duration, delivery intensity, and setting/modality (i.e., self-guided
2022, and was registered on PROSPERO (CRD42023397752). The or in-clinic). Thus, a trial providing written relaxation technique ma-
draft systematic review was reviewed by AHRQ, Patient-Centered terials to participants and a trial conducting in-person weekly re-
Outcomes Research Institute (PCORI), four members of the TEP, and laxation sessions were both considered as relaxation training. Two
five additional solicited peer reviewers. A revised draft was posted analysts and four migraine experts reviewed all categorizations to
for public comment on the AHRQ Effective Healthcare website ensure reliability.
(September 5, 2023 to October 20, 2023) that received comments We classified education-only comparison groups in trials as at-
from two people and the American Psychological Association. tention controls if: (1) authors indicated their designation as such, (2)
the allocated time and interaction with trial staff were comparable to
the intervention arm, and (3) the educational component lacked ad-
Literature search ditional behavioral interventions (e.g., relaxation training, cognitive
behavioral therapy [CBT]). Interventions not meeting these criteria
A research librarian searched MEDLINE and Embase (via Embase. but still functioning as a minimal intervention control were labeled as
com), PsycINFO (via Ovid), PubMed (in process citations, to capture minimal intervention. We classified education as a behavioral inter-
items not yet indexed in MEDLINE), and the Cochrane Database of vention when aimed to modify behavior or ways of thinking (as per
Systematic Reviews for randomized controlled trials, systematic re- our definition of behavioral interventions).
views, and meta-analyses published from 1975 to August 24, 2023. For analysis, many trials employed multicomponent treatment
A second librarian independently peer-reviewed the search strategy packages, with different trials often using different combinations.
using the PRESS Checklist. We hand-searched reference lists of rele- To assess effectiveness, we grouped trials based on the presence
vant systematic reviews to identify additional trials. File S1 contains of a common component, disregarding the variety or dosage of
the search strategies. additional elements within the treatment regimen. For example,
the CBT section discusses data on the three-component interven-
tion by Klan et al.15 (CBT + progressive muscle relaxation + educa-
Trial selection tion) as well as the six-component intervention by Lemstra et al.16
(CBT + relaxation training + education + exercise + massage ther-
Our eligibility criteria appear in Table 1. The review team was com- apy + physical therapy). This is because both interventions had a
prised of experienced systematic reviewers and employed dual CBT component. These same two studies were also analyzed for
|

TA B L E 1 Trial eligibility criteria.

Aspect Inclusion Exclusion

Patients Children (aged 6–11 years), adolescents (aged 12–17 years), and adults (18 years or older) with Trials conducted exclusively:
migraine headache (episodic or chronic)
We did not require trials to include only individuals with an International Classification of • Among individuals in
Headache Disorders diagnosis of migraine headache institutions (e.g., psychiatric
inpatients, long-term care
facilities, incarcerated
populations)
≥80% of trial participants had migraine headache, or the trial reports a subgroup analysis • Parents, for trials with
composed of at least 80% patients with migraine interventions targeting children
and adolescents
For trials with participants with other headache types (e.g., medication-overuse headache, • Individuals with psychotic
tension-t ype headache, cluster headache) in addition to migraine, we included the trial if at disorders
least 80% of participants had migraine
Interventions Migraine-focused behavioral interventions used for prevention, administered either alone or Trials focused solely on:
with pharmacotherapy, delivered in-person, via telehealth, or with e-or mHealth
1. CBT • Physical therapy
• CBT • Exercise
• Cognitive therapy • Catharsis therapy (e.g., written
emotional disclosure)
• MBCTa • Occupational therapy
• Behavioral therapy • Creative arts therapy (art
therapy, music therapy, dance
therapy)
• SMT • Massage
• Coping skills training
• LCT
• Parent/caregiver operant training (parent or caregiver reinforces coping behaviors)
• Problem-solving training
2. Biofeedback
• Thermal/temperature biofeedback (hand warming/thermal biofeedback; often feedback
of skin temperature from finger)
• Electromyographic biofeedback (feedback of electrical activity from muscles of scalp,
neck, or upper body)
• Heart rate variability biofeedback
• Electrocardiographic biofeedback
• Pulse
• Blood volume pulse
• Respiratory
• Electroencephalography/neurofeedback
3. Relaxation training
• Diaphragmatic breathing
• Progressive muscle relaxation (alternatively tensing/relaxing selected muscles)
• Autogenic feedback (use of calm, self-soothing statements to promote a state of deep
relaxation)
• Autogenic training
• Guided imagery/guided visual imagery (children/adolescents)
4. Mindfulness-based stress reduction
• Meditation (use of silently repeated word or sound to promote mental calm and
relaxation)
• MBCTa
|

TA B L E 1 (Continued)

Aspect Inclusion Exclusion

• Transcendental meditation
• Guided imagery/guided visual imagery (adults)
5. Acceptance and commitment therapy
6. Education
• Education (skills, lifestyle, exercise, nutrition, hydration, stress
management, sleep hygiene)
• Neuroscience education therapy
• Healthy lifestyle counseling
• Sleep counseling
• Trigger avoidance
• Weight management (informational)
• Diary/tracking
7. Hypnotherapy
8. Trauma-informed therapy
• EMDR
• Trauma-focused therapy
9. DBT
10. Motivational interviewing and stages of change
11. Professionally led support groups/peer support
12. Combination therapies
Non-headache-focused behavioral interventions
• CBT for insomnia or depression/anxiety
• Sleep hygiene counseling
• Parent/caregiver operant training (parent or caregiver reinforces adaptive sleep behaviors)
• Healthy lifestyle counseling
Comparisons Effectiveness Comparators not listed as included
• No intervention (e.g., waitlist, usual care)
• Minimal intervention (e.g., educational materials without skills training)
• Most active: attention control, sham, or placebo
Comparative effectiveness
A different eligible behavioral intervention, or a pharmacological intervention in one of the
following class:
• Alpha agonists
• Angiotensin-converting enzyme inhibitors/angiotensin receptor blockers
• Anti-seizure medications
• Antihistamines (for children and adolescents only)
• Beta-blockers
• onabotulinumtoxinA
• Calcitonin gene-related peptide antagonists
• Calcium channel blockers
• Other antidepressants
• Serotonin norepinephrine reuptake inhibitors
• Tricyclic antidepressants
Component contribution
• The trial design permitted the isolation of the contribution of a single behavioral
component (e.g., A + B vs. A measures the contribution of B)
|

TA B L E 1 (Continued)

Aspect Inclusion Exclusion

Outcomes Trial must have reported one or more of three primary outcomes Some other outcomes were included
in the full report, but are not
discussed in this article
Migraine/headache attack frequency
• Migraine/headache count: migraine days per month, migraine attacks per month,
headache days per month, or headaches per month
• Responder rate: 50% or more reduction in one of the above quantities
Functional status/disability
• MIDAS, PedMIDAS, HIT-6, HANA, MIBS, FIS, FDI (parent form), FDI (child and
adolescent), IMPAC, PDI
QoL
• Migraine-specific: MSQ
Trial design • Randomized controlled trials reporting outcomes for ≥10 participants per treatment arm Excluded crossover trials not
criteria reporting period 1 data separately
• Period 1 data from crossover RCTs Excluded reviews, letters,
guidelines, position statements,
and commentaries
• Published in English language Excluded single arm or
nonrandomized controlled trials
• Published 1975 or after Unpublished trials/not published
as a full-length article (e.g.,
conference abstract)
• Subgroup analyses addressing patient factors must have reported outcomes on at least 10 SRs were used only to identify
patients per subgroup potential RCTs for inclusion
Setting Any noninpatient setting Hospitalized patients
Trials conducted in countries rated as “very high” on the 2022 Human Development Index Trials conducted in other countries
(as defined by the United Nations Development Program). This was to focus our efforts on
treatment settings relatively similar to US settings
Timing Trials must have reported 1 of our primary outcomes at 4 weeks or longer after treatment Earlier timepoints
initiation

Abbreviations: CBT, cognitive behavioral therapy; DBT, dialectical behavioral therapy; EMDR, eye movement desensitization and reprocessing; FDI,
Functional Disability Inventory; FIS, Fatigue Impact Scale; HANA, Headache Needs Assessment; HIT-6, Headache Impact Test-6; LCT, learning to
cope with triggers; MBCT, mindfulness-based cognitive therapy; MIBS, Migraine Interictal Burden Scale; MIDAS, Migraine Disability Assessment;
MSQ, Migraine-Specific Quality of Life Questionnaire v2.1; PDI, Pain Disability Inventory; PedMIDAS, Pediatric Migraine-Specific Disability
Assessment; QoL, quality of life; RCT, randomized controlled trial; SMT, stress management training; SR, systematic review.
a
MBCT was categorized as a combination of cognitive therapy and MBSR, so it appears under two categories.

relaxation training effectiveness, because both included relaxation meta-analyses of standardized mean differences (SMDs) using the
training. Hedges g approach. If a trial reported multiple metrics of migraine
disability or migraine QoL, we chose for meta-analysis the metric
that was more commonly reported among our included trials (al-
Data analysis though we extracted all such data). To facilitate interpretation,
we used typical standard deviations to convert summary SMDs
We conducted random-effects meta-analyses using the restricted to a more commonly understood metric (e.g., Pediatric Migraine-
maximum-likelihood approach and the inverse-variance weight- Specific Disability Assessment for migraine disability in youth). We
ing scheme using the meta package (version 6.2-1) in R version did not conduct sensitivity analyses. Data were extracted by a sin-
4.1.3 (R Foundation for Statistical Computing, Vienna, Austria).17 gle team member.
Wherever possible, we computed effect sizes and 95% confidence We defined time points from the beginning of the intervention.
intervals (CIs) using standard methods. We measured heterogene- If a trial reported change from baseline data in addition to at fol-
ity using τ 2, complemented by I2. Where necessary, we estimated low-up data, we prioritized the former. Some trials reported multiple
mean and standard deviation from median and interquartile range, follow-up time points (and we extracted them all), but for meta-
or range using the methods described by Wan et al.18 Because trials analyses, we chose the one closest to 12 weeks after the start of
often used different metrics for the same construct, we conducted treatment, as this was the most commonly reported time point. Our
|

meta-analyses did not account for different studies having different not report the country in which patients were enrolled). The median
durations of interventions. number of patients at baseline was 75 (interquartile range = 37–111),
We considered a two-tailed p-value < 0.050 to represent statistical the weighted average patient age was 42 years, and 84% of partic-
significance. To assess the clinical importance of findings, we consulted ipants were women. Fourteen US trials reported race or ethnicity,
our TEP and the published literature to determine a minimal important with a median 73% White, 14% Black, 4% Asian/Pacific Islander, 8%
difference (MID) for each primary outcome. For migraine/headache at- Hispanic, and 1% Native American or Alaska Native. The baseline
tack frequency, the MID was set at 1 migraine day/month. For disability, number of days per month that patients experienced migraine or
the MID was 3 points on the Migraine Disability Assessment (MIDAS; headache attacks per month (reported by 25 trials) ranged from 4
which ranges 0–90). We identified no empirical literature on the MID to 25 (median = 10). Few studies reported on comorbid anxiety and
for MIDAS, and we chose 3 points because it represents approximately depression; 47% of patients had comorbid anxiety (four trials), and
3% of the scale range, similar to our MID for attack frequency. For 46% had comorbid depression (seven trials). In two thirds of trials
migraine-specific QoL, the MID was 19 points on the 0–100 Migraine- (33 trials), behavioral interventions employed multicomponent in-
Specific Quality of Life v2.1 (based on a trial by Cole et al.).19 terventions, whereas 34% (17 trials) assessed single behavioral in-
terventions. The trial duration (time from treatment initiation to last
follow-up) ranged from 1 to 37 months (median = 6 months).
Evidence rating For the 50 adult trials, we rated the overall risk of bias to be low
for three trials (6%), some concerns for 10 trials (20%), high for 35 trials
We evaluated risk of bias in individual trials as well as the strength of (70%), and a mix of some concerns and high (depending on the type
evidence (SOE) for each body of evidence related to a specific com- of treatment comparison) for two trials (4%). Our concerns mostly in-
parison and outcome. To assess risk of bias, we employed the revised volved incomplete data and possible measurement bias. Specifically,
Cochrane risk of bias tool for randomized trials. 20 File S2 contains incomplete data often occurred due to the number of patients not pro-
our study-by-study risk of bias ratings. viding data at follow-up. Measurement bias was mostly due to differ-
For assessing SOE, we adhered to the 2013 AHRQ Methods ences in attention time from trial staff and differential expectations of
Guide,21 which considers multiple inputs (trial design, risk of bias, benefit in control groups (e.g., waitlist) versus treatment groups. The
consistency of results across trials, directness of the evidence, effect purpose of an attention control group, which six trials used, is to try
estimate precision, reporting bias, strong dose–response association, to account for these concerns. Specifically, if the control group is seen
large magnitude of effect, and whether controlling for all plausible for approximately the same amount of time by trial staff as the actively
confounders would increase the effect). The SOE rating was high, treated group, and the control group's treatment could reasonably be
moderate, low, or insufficient. This rating is made separately for each believed to improve migraine-related outcomes, then differential ex-
outcome of each comparison. A rating of insufficient is given if the ev- pectations are an unlikely reason for why outcomes may have differed.
idence does not permit a conclusion for that outcome (e.g., the CI was We recognize that blinding is rarely possible in behavioral trials, but
wide enough to include both favors A and favors B). Two analysts rated some trials were able to control for differential expectations in other
the SOE independently, with discrepancies resolved by consensus. ways (e.g., sham treatment). See the Appendix for the full report on
domain-specific risk of bias ratings.
We included 13 trials of children/adolescents (published from
R E S U LT S 1984 to 2015) that had enrolled a total of 1414 children/adolescents
(Table 3).73–85 Eight trials were conducted in the United States, three
Evidence base in Germany, one in Canada, and one in Sweden. Twelve trials em-
ployed multiple behavioral components together, and one trial em-
For the full report, searches identified 1791 potentially relevant refer- ployed only a single behavioral component. The median number at
ences (Figure 1). Among these, 127 full-text articles were excluded, baseline was 36 (interquartile range = 30–42), the weighted average
predominantly due to reasons such as not meeting population criteria, age was 14.5 years, and 61% of participants were girls. Eight US trials
not evaluating a comparison of interest, or not assessing a key outcome reported race or ethnicity, with a median of 90% White and 10%
of interest. For a list of all articles excluded at full text, see File S3. Black. The migraine or headache days per month (reported by four
For adults, we included 50 randomized trials (published trials) ranged from 8 to 23 (median = 10), and the baseline number
from 1978 to 2023) assessing behavioral interventions (see of migraine episodes or headaches per month (reported by six trials)
Table 2) .15,16,22–56,58–62,64–67,69–72 Collectively, these trials enrolled ranged from three to 48 (median = 14). Only one trial85 reported co-
6024 adults; 36 trials addressed effectiveness, 16 comparative effec- morbid anxiety (present in 25% [6/24]) and depression (13% [3/24]).
tiveness, and three addressed the contribution of a specific behav- The trial duration (time between the start of treatment and the last
ioral component. Some trials addressed multiple areas. Twenty-four follow-up) ranged from 1 to 16 months (median = 7 months).
trials were conducted in the United States, five in the Netherlands, For children/adolescents, we rated the overall risk of bias to be
four in Germany, three in Canada, three in Italy, two in Sweden, two in low for one trial (8%), some concerns for two trials (15%), high for
the United Kingdom, and one each in six other countries (one trial did eight trials (62%), and a mix of some concerns and high (depending
|

F I G U R E 1 Trial flow diagram. This figure shows the counts and various stages of our article screening process. Searches identified 1791
potentially relevant references, of which 106 were duplicates. An additional 61 potentially relevant references were identified from the
reference lists of relevant systematic reviews. We excluded 1526 citations at the abstract level and ordered the remaining 220 for full-text
consideration. Of these, we excluded 127 studies, with the most common reasons for exclusion being “Does not meet population criteria,” “Does
not evaluate a comparison of interest,” and “Does not evaluate a key outcome of interest.” As a result, we included 63 studies in 93 publications.

on the type of treatment comparison) for two trials (15%). The rea- CBT to treatment as usual care/waitlist, one trial used an attention
sons for our risk of bias ratings were similar in the pediatric literature control, and one trial used a placebo control. Variability in control
as compared to the adult literature. groups also occurred with other treatments (e.g., biofeedback, re-
laxation training; see Table 2).
For migraine/headache attack frequency, our meta-analysis of
Adults: Effectiveness 10 trials (Figure 2A, combining data from 839 patients) found a sum-
mary SMD of −0.33 (95% CI = −0.55 to −0.11, with a τ 2 of 0.0668),
Cognitive behavioral therapy favoring CBT, translating to a difference of −1.1 migraine days per
month (95% CI = −1.8 to −0.4) with CBT compared with no treat-
We included 12 trials assessing the effectiveness of CBT for adults. ment or treatment as usual. Neither Bromberg et al. 24 nor Lemstra
Notably, control arms differed across studies; 10 trials compared et al.16 reported data on this outcome.
TA B L E 2 Included trials of adults on effectiveness, comparative effectiveness, or component contributions.
| 676

Episodic, chronic, or Comparative Components

Trial Baseline N mixed Behavioral treatment(s) Control group(s) Effectiveness effectiveness contribution

Aguirrezabal (2019)22 116 NR • Education TAU or no intervention ✓

Blanchard (1978)23 37 NR • Relaxation training (PMR) TAU or no intervention ✓ ✓
• Thermal biofeedback + relaxation training
(autogenic training)
Bromberg (2012)24 189 100% chronic • CBT + biofeedback + relaxation training + TAU or no intervention ✓
education
Brown (1984)25 39 NR • MBSR via guided imagery, relaxing statements Attention control ✓ ✓
• MBSR via guided imagery, scene details
Cousins (2015)26 73 Mixed (% NR) • CBT + relaxation training (PMR + deep breathing) TAU or no intervention ✓
27
Cuneo (2023) 36 100% chronic • Biofeedback TAU or no intervention ✓
D'Souza (2008)28 90 NR • Relaxation training (autogenic training + deep Attention control ✓
breathing) Written emotional
disclosure (not an included
treatment)
Day (2014)29 36 NR • MBCT TAU or no intervention ✓
de Tommaso (2017)30 33 100% episodic • Nociceptive blink reflex biofeedback Topiramate ✓
• Nociceptive blink reflex biofeedback + topiramate
Dindo (2020)31 103 100% episodic • ACT therapy + education None ✓
• Relaxation training + education + deep breathing
Dittrich (2008)32 30 NR • Relaxation training (PMR) + exercise TAU or no intervention ✓
33
Fritsche (2010) 40 100% episodic • CBT + relaxation training (PMR) + education None ✓
• PMR + education
Flynn (2019)34 150 NR • Hypnotherapy TAU or no intervention ✓
35
Grazzi (2021) 35 100% episodic • ACT TAU or no intervention ✓
Hedborg (2011)36 76 100% episodic • Relaxation training + healthy lifestyle counseling Minimal control ✓
+ sleep counseling + stress management
• Relaxation training + healthy lifestyle counseling
+ sleep counseling + stress management +
massage therapy
Holroyd (1988)37 37 100% chronic • Thermal biofeedback + relaxation training Attention control ✓
38
Holroyd (2010) 232 NR • CBT + relaxation training (PMR) + propranolol Placebo ✓ ✓
• CBT + relaxation training (PMR) Propranolol
Janssen (1986)39 NR NR • Relaxation training (PMR) None ✓
• Relaxation training (autogenic training)
Kewman (1980) 40 23 100% episodic • Thermal biofeedback Attention control ✓
HEADACHE

Episodic, chronic, or Comparative Components

Trial Baseline N mixed Behavioral treatment(s) Control group(s) Effectiveness effectiveness contribution
HEADACHE

Klan (2022)15 106 96% episodic, 4% • CBT + relaxation training (PMR) + education TAU or no intervention ✓ ✓
chronic • Relaxation training
Kleiboer (2014) 41 368 Mixed (% NR) • CBT + relaxation training + education TAU or no intervention ✓
42
Kohlenberg (1981) 117 100% episodic • CBT + thermal biofeedback + education + Attention control ✓
relaxation training + MBSR (meditation)
Kropp (1997) 43 38 Mixed (% NR) • CBT + relaxation training None ✓
• Biofeedback
Lemstra (2002)16 80 100% chronic • CBT + relaxation training + education + exercise + TAU or no intervention ✓
massage therapy + physical therapy
Matchar (2008) 44 614 100% chronic • Relaxation training + education TAU or no intervention ✓
45
Mathew (1981) 715 NR • Thermal and EMG biofeedback TAU or no intervention ✓ ✓
• Thermal and EMG biofeedback + propranolol Propranolol
• Thermal and EMG biofeedback + amitriptyline Amitriptyline
• Biofeedback + amitriptyline + propranolol Propranolol + amitriptyline
Mérelle (2008) 46 127 100% episodic • Relaxation training (autogenic training) + education TAU or no intervention ✓
47
Minen (2020) 62 NR • Relaxation training (PMR) TAU or no intervention ✓
48
Minen (2020) 139 NR • Relaxation training (PMR) TAU or no intervention ✓
49
Minen (2021) 52 NR • Heart rate variability biofeedback TAU or no intervention ✓
50
Odawara (2015) 27 100% episodic • Thermal biofeedback + EMG biofeedback + PMR TAU or no intervention ✓
51
Pickering (2012) 42 100% episodic • Relaxation training TAU or no intervention ✓
52
Rausa (2016) 47 100% chronic • EMG biofeedback Attention control ✓
53
Reich (1989) 392 100% chronic • Relaxation training Microcurrent electrical ✓
• Thermal biofeedback therapy (not an included
• Combination of any two interventions from the treatment)
other groups
Richardson (1989)54 47 Mixed (% NR) • CBT + relaxation training (PMR; in clinic) TAU or no intervention ✓
• CBT + relaxation training (PMR; self-administered)
Rothrock (2006)55 100 19% episodic, 81% • Education (general migraine information) Minimal control ✓
chronic
Sargent (1986)56,57 136 NR • Thermal biofeedback + relaxation training TAU or no intervention ✓ ✓ ✓
• EMG biofeedback + relaxation training
• Relaxation
Seminowicz (2020)58 98 100% episodic • MBSR None ✓
• Stress management training + education
Seng (2019)59 60 48% episodic, 52% • MBCT + education TAU or no intervention ✓
|

chronic
(Continues)
677

TA B L E 2 (Continued)

Episodic, chronic, or Comparative Components

Trial Baseline N mixed Behavioral treatment(s) Control group(s) Effectiveness effectiveness contribution

Simshäuser (2022)60 54 100% Episodic • MBCT TAU or no intervention ✓

61
Sorbi et al. (1984) 21 100% episodic • CBT + PMR + thermal biofeedback None ✓
• CBT + PMR
Sorbi (1986)62,63 29 NR • CBT None ✓
• Relaxation training (autogenic training)
Underwood (2023)64 727 45.5% episodic, • Education (healthy living, general migraine Minimal control ✓
54.5% chronic information)
Varkey (2011)65 91 99% episodic, 1% • Relaxation training Topiramate ✓
chronic
Vasiliou (2021)66 94 Mixed (% NR) • ACT TAU or no intervention ✓
67,68
Wachholtz (2008) 83 NR • Spiritual meditation None ✓
• Internally focused secular meditation
• Externally focused secular meditation
• Relaxation training (PMR)
Wells (2021)69 89 Mixed (% NR) • MBSR None ✓
• Education (general migraine information, stress)
Wittchen (1983)70 20 NR • CBT + relaxation training + education TAU or no intervention ✓

Note: A checkmark (✓) indicates that the trial addressed that aspect of the treatment. See the Methods section for definitions of the different types of comparison groups.
Abbreviations: ACT, acceptance and commitment therapy; CBT, cognitive behavioral therapy; EMG, electromyographic; MBCT, mindfulness-based cognitive therapy; MBSR, mindfulness-based stress
reduction; NR, not reported; PMR, progressive muscle relaxation; TAU, treatment as usual.
HEADACHE

Episodic, chronic, or Comparative Component

HEADACHE

Trial Baseline N mixed Behavioral treatment(s) Comparison group(s) Effectiveness effectiveness contribution

Albers (2015)73 900 100% episodic • CBT + relaxation training + TAU or no intervention ✓
education
Allen (1998)74 27 100% episodic • Thermal biofeedback + education None ✓
• Thermal biofeedback
Connelly (2006)75 37 76% episodic, 24% • CBT + relaxation training + TAU or no intervention ✓
chronic education
Cottrell (2007)76 30 100% episodic • CBT + thermal biofeedback Attention control ✓
+ relaxation training
(PMR) + education + activity
pacing
Fichtel (2001)77 37 100% episodic • Relaxation training (PMR) TAU or no intervention ✓
78
Gerber (2010) 34 100% episodic • Thermal biofeedback + EMG None ✓
biofeedback + relaxation training
+ education
• CBT+ PMR + education
Labbé (1984)79 28 100% episodic • Thermal biofeedback + relaxation TAU or no intervention ✓
training (autogenic training)
Labbé (1995) 80 30 100% episodic • Thermal biofeedback + relaxation TAU or no intervention ✓ ✓
training (autogenic training)
• Relaxation training (autogenic
training)
Powers (2013) 81 135 100% chronic • CBT + thermal biofeedback + EMG None ✓
biofeedback + relaxation training
+ amytriptyline
• Education + amytriptyline
Rapoff (2014) 82 35 Mixed (% NR) • CBT + relaxation training + pain Minimal control ✓
management education
Richter (1986) 83 42 100% episodic • CBT Attention control ✓ ✓
• Relaxation training (PMR + deep
breathing)
Sartory (1998) 84 43 100% episodic • CBT+ PMR Metoprolol ✓
• CBT + blood volume pulse
biofeedback
Scharff (2002) 85 36 100% episodic • CBT + thermal biofeedback + Attention control ✓
relaxation training TAU or no intervention

Note: A checkmark (✓) indicates that the trial addressed that aspect of the treatment. See the Methods section for definitions of the different types of comparison groups.
|

Abbreviations: CBT, cognitive behavioral therapy; EMG, electromyographic; NR, not reported; PMR, progressive muscle relaxation; TAU, treatment as usual.
679

F I G U R E 2 Meta-analyses of cognitive behavioral therapy in adults. (A) Migraine or headache frequency. (B) Migraine disability. (C)
Migraine-specific quality of life. B, biofeedback; CBT, cognitive behavioral therapy; Chr, only patients with chronic migraine; CI, confidence
interval; E, education; Epi, only patients with episodic migraine; HA, headaches (unreported timeframe); HA d/w, headache days per week;
HA d/28 d, headache days per 28-day period; HA/w, headaches per week; HDI, Headache Disability Inventory; HIT-6, HIT-6, Headache
Impact Test-6; MBSR, mindfulness-based stress reduction; Mi d/w, migraine days per week; Mi d/30 d, migraine days per 30-day period;
Mi/w, migraine attacks per week; MIDAS, Migraine Disability Assessment; Mix, both episodic and chronic patients; MSQoL, Migraine-
Specific Quality of Life; NA, not applicable; NR, not reported; O, other (neither behavioral nor pharmacologic); P, pharmacologic; PDI, Pain
Disability Inventory; R, relaxation training; SMD, standardized mean difference; T, tailored treatment; TAU, treatment as usual.

Seven trials used one of the key instruments for measuring mi- due to unreported dispersion) found similar reductions in disability
graine disability, and our meta-analysis (Figure 2B, combining data in both the CBT and control groups, with no statistical test reported.
from 712 patients) found a summary SMD of −0.32 (95% CI = −0.66 Overall, this outcome is insufficient to permit conclusions.
to 0.03). This result corresponds to 7 points on the MIDAS (95% CI Only two of 11 trials reported migraine-specific QoL (meta-
= −17 to 3). This result is insufficient to permit conclusions, as the analysis in Figure 2C, combining data from 464 patients). Whereas
CI included both no effect (MIDAS difference of 0) and a clinically Holroyd et al.38 found a statistically significant advantage for the
important effect (MIDAS difference of −17). The likely reason for the groups receiving CBT, Kleiboer et al.41 found no statistically signifi-
wide CI is differing effect sizes rather than small study sizes, as evi- cant difference between groups. The inconsistency produced a wide
denced by τ 2 = 0.1643. Wittchen70 (not included in the meta-analysis confidence interval in the meta-analysis, precluding a conclusion.
|

F I G U R E 3 Meta-analyses of biofeedback in adults. (A) Migraine or headache frequency. (B) Migraine disability. B, biofeedback; CBT,
cognitive behavioral therapy; Chr, only patients with chronic migraine; CI, confidence interval; E, education; Epi, only patients with episodic
migraine; HA d/w, headache days per week; MBSR, mindfulness-based stress reduction; Mi d/w, migraine days per week; Mi/w, migraine
attacks per week; MIDAS, Migraine Disability Assessment; NA, not applicable; R, relaxation training; SMD, standardized mean difference;
TAU, treatment as usual.

Biofeedback trials, three reported this outcome. Odawara et al.50 did not report
the disability scale they used but did report that the biofeedback
We included 13 trials on effectiveness that administered biofeed- group improved statistically significantly more than the control
back to adults. For migraine/headache attack frequency, six of the group. The other two trials,30,49 reported that there was no statisti-
13 reported data for meta-analysis (Figure 3A, combining data from cally significant difference between groups.
212 patients). The summary SMD was insufficient to permit con- Only Minen et al.49 reported data on the Migraine-Specific Quality
2
clusions (−0.37, 95% CI = −0.87 to 0.12, τ = 0.255); as the CI over- of Life v2.1, with no statistically significant difference between groups.
lapped with a null effect, it was not narrow enough to indicate the
absence of a difference. Of the other seven trials, three reported this
outcome. Sorbi and Tellegen61 found no statistically significant dif- Relaxation training
ference between groups in the percentage reduction in frequency.
Neither Sargent et al.56,57 nor Blanchard et al. 23 reported a statistical We included 23 trials assessing relaxation training for migraine
test between biofeedback and no treatment. prevention in adults. For migraine/headache attack frequency, our
For migraine disability, only two of the 13 trials reported effect meta-analysis of 13 trials (Figure 4A, combined n = 1091) favored re-
size calculable information on included instruments measuring this laxation training, with an SMD of −0.31 (95% CI = −0.50 to −0.11),
outcome, and our meta-analysis was insufficient to permit conclu- translating to 1 fewer migraine day/month (95% CI = 0.4–1.6 fewer
sions (Figure 3B, combining data from 160 patients). Of the other days/month). Four additional trials reported this outcome but had
|

insufficient data for effect size calculation and did not report statisti- Education alone
32,56,57
cal tests. Three had point estimates in the direction favoring
relaxation training, and the other48 was in the direction favoring the Three trials specifically examined education's impact in
control group. adults. 22,54,55,64,71 This section differs from those above on CBT,
Our meta-analysis of migraine disability included 10 of 23 trials biofeedback, and relaxation training, because those sections consid-
(Figure 4B, combining data from 1409 patients). The summary SMD ered any use of a single component regardless of other additional
was −0.19 (95% CI = −0.41 to 0.03, which translates to a MIDAS re- components, whereas this section examines only education when
sult [range 0–90] of −5 points [95% CI = −11 to 1]), which is insuffi- used in isolation as a way to change behavior.
cient to permit conclusions. The wide CI was likely due to differing For migraine/headache attack frequency, Underwood et al.64
effect sizes (τ2 = 0.079). Three additional trials reported this outcome found a statistically significant effect against education (the effect cor-
but were not included in meta-analyses. One found a statistically responded to a difference of 0.8 migraine days/month, 95% CI = 0.2–
significant advantage for the relaxation training group,51 another re- 1.4). In contrast, Rothrock et al.55 reported only mean reductions and
37
ported no statistically significant between-group difference, and the no dispersion, but at follow-up, the education group had improved by
70
third did not report a statistical test, but we conducted it and found six headaches per month, whereas there was zero change in the control
no statistical significance. group. Thus, the results conflict with Underwood et al.64 Aguirrezabal
Three of the 23 trials reported migraine-specific QoL data, and et al.22 did not report data on this outcome.
our meta-analysis (Figure 4C, combining data from 572 patients) For migraine disability, all three trials found a statistically sig-
was insufficient to permit conclusions (SMD −0.56, 95% CI = −1.38 nificant advantage of education. Rothrock et al.55 reported that
to 0.26). The CI overlapped with a null effect and was not narrow MIDAS scores improved statistically significantly more in the edu-
enough to indicate the absence of a difference. cation group than in the control group (effect size not calculable).
Aguirrezabal et al. 22 found that the percentage of patients who
experienced at least a 50% improvement in MIDAS score was sta-
Mindfulness-based treatments tistically significantly higher in the education group (70% vs. 35%).
Underwood et al.64 reported a statistically significant advantage of
25
Five trials assessed mindfulness-based treatments in adults. Brown education (corresponding to a Headache Impact Test-6 [HIT-6] dif-
59
employed single-component treatment with MBSR. Seng et al. reference of 1.2 points, 95% CI = 0.1–2.3).
ported combination treatment with CBT, mindfulness, and educa- None of the trials reported migraine-specific QoL.
tion (CBT and mindfulness together are called MBCT); Simshäuser
et al.60 and Day et al. 29 used MBCT; and Kohlenberg and Cahn42 re-
ported a multicomponent treatment that included CBT, relaxation Acceptance and commitment therapy
training, biofeedback, and meditation.
All five reported migraine/headache attack frequency and Two trials assessed acceptance and commitment therapy (ACT) com-
enough information for effect size calculation (Figure 5A, combining pared to usual care for migraine prevention in adults.35,66 Only one
data from 227 patients). The result of this meta-analysis was statisti- small trial (n = 35), Grazzi et al.,35 reported on headache frequency,
cally in favor of MBSR-based treatments, with an SMD of −0.30 (95% with the authors reporting that ACT reduced migraine/headache at-
CI = −0.54 to −0.05), corresponding to 1 fewer migraine day/month tack frequency (−2.3 migraine days per month, 95% CI = −4.5 to −0.03).
(95% CI = 0.2–1.8 fewer days/month). There was little between-trial For migraine-related disability, Grazzi et al.35 found no statis-
heterogeneity (τ2 = 0.006). For migraine disability, we meta-analyzed tically significant difference for either MIDAS or HIT-6, whereas
the two trials that reported data in this category (Figure 5B, com- Vasiliou et al.66 reported a statistically significant advantage of ACT
bining data from 103 patients). A random-effects meta-analysis was (SMD corresponding to a MIDAS difference of 18 in the direction of
insufficient to permit conclusions (SMD = −0.48, 95% CI = −1.02 to the ACT group, 95% CI = 4–31). Our meta-analysis indicated insuffi-
0.06, indicating too wide to indicate a difference or a lack of a clini- cient evidence to permit conclusions due to a wide CI (SMD corre-
cally important difference). None of the five trials reported migraine- sponding to a MIDAS difference of −3, 95% CI = −33 to 27). Neither
specific QoL. trial reported data on migraine-related QoL.

F I G U R E 4 Meta-analyses of relaxation training in adults. (A) Migraine or headache frequency. (B) Migraine disability. (C) Migraine-
specific quality of lifeB, biofeedback; CBT, cognitive behavioral therapy; Chr, only patients with chronic migraine; CI, confidence interval; E,
education; Epi, only patients with episodic migraine; HA, headaches (unreported timeframe); HA d/28 d, headache days per 28-day period;
HA d/w, headache days per week; MBSR, mindfulness-based stress reduction; Mi d/30 d, migraine days per 30 day period; Mi d/w, migraine
days per week; Mi/4 w, migraine attacks per 4-week period; Mi/w, migraine attacks per week; MIDAS, Migraine Disability Assessment;
Mix, both episodic and chronic patients; MSQoL, Migraine-Specific Quality of Life; NR, not reported; O, other (neither behavioral nor
pharmacologic); P, pharmacologic; R, relaxation training; SMD, standardized mean difference; T, tailored treatment; TAU, treatment as usual.
15264610, 2025, 4, Downloaded from https://headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14914 by Nat Prov Indonesia, Wiley Online Library on [13/08/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
|683
HEADACHE
|

Hypnotherapy For migraine-specific QoL, the trial found that the combined
behavioral intervention was associated with a greater improvement
Flynn34 compared hypnotherapy (the only treatment component) than with propranolol. The improvement with the behavioral inter-
with usual care. For migraine/headache attack frequency, there was vention at the 10-month follow-up was both clinically important and
no statistically significant difference (SMD corresponding to a dif- statistically significant, with an SMD of 0.89 (95% CI = 0.49–1.28).
ference of 0, 95% CI = −2 to 2). For migraine-related disability, the This SMD corresponds to a difference of 12 points on the Migraine-
trial reported a statistically significant advantage of hypnotherapy Specific Quality of Life Questionnaire v2.1 (MSQ; 95% CI = 7–18).
(SMD corresponding to a MIDAS difference of 42, 95% CI = 23–61). The combined behavioral and pharmacologic group had an even
The trial did not report migraine-specific QoL. greater improvement than pharmacologic treatment alone, with an
SMD of 2.78 (95% CI = 2.28–3.28).

Adults: Comparative effectiveness

MBSR versus stress management training + education
We examined 17 different comparisons in adults, but only four had
sufficient evidence for conclusions (listed in four sections below). For migraine attack frequency, Seminowicz58 found a statistically
The other comparisons (listed in Table 4) were each made by a sin- significant difference favoring MBSR over stress management train-
gle trial, and we rated the evidence as insufficient, typically due to ing + education (SMD = −0.64, 95% CI = −1.06 to −0.23, corre-
statistically nonsignificant effects in single small trials at high risk of sponding to a difference in migraine days/month of −2.1, 95% CI =
bias. See the full report for details. In the sections below, we only −3.5 to −0.8).
describe outcomes that permitted conclusions (i.e., an SOE rating of
low, moderate, or high).
CBT + relaxation training versus biofeedback

MBSR versus education For migraine attack frequency, Kropp et al.43 found a statistically
significant difference favoring biofeedback (SMD = −0.69, 95% CI
69
Wells et al. found that MBSR was associated with a greater = −1.34 to −0.03), corresponding to a difference in migraine days/
improvement in migraine-related disability, as measured by the month of −2.2 (95% CI = −4.4 to −0.1).
MIDAS, compared with education (SMD = 0.70, 95% CI = 0.27–
1.13). This difference corresponds to an 18-p oint shift on the
0–90 MIDAS scale (95% CI = 7.18–30.06). MBSR also resulted Adults: Component contributions
in a greater improvement in HIT-6 scores at 8-week follow-up
(SMD = 0.86, 95% CI = 0.42–1.29). This equates to a HIT-6 differ- Both comparisons in this category (the effect of adding CBT, and
ence of 5.8 (95% CI = 2.81–8.64). Because there was only one trial the effect of adding biofeedback) were insufficient to permit conclu-
of this outcome/comparison, the evidence was insufficient to per- sions. See Table 4 and the full report for details.
mit a conclusion.

Pediatric: Effectiveness
CBT + relaxation training versus propranolol
Cognitive behavioral therapy
Holroyd et al.38 compared a combination of CBT and relaxation
training with propranolol, which had a starting dosage of 60 mg/ We included six trials that measured the effectiveness of CBT for
day (titrated as tolerated or switched to nadolol). After 10 months children/adolescents. Our meta-analysis of four trials of migraine/
of follow-up, the results indicated a statistically significantly greater headache attack frequency (Figure 6A, combining data from 112 pa-
reduction in migraine attack frequency with the use of propranolol tients) was inconclusive (SMD = −0.29, 95% CI = −0.66 to 0.09), as
than with use of the combination of CBT and relaxation training. This the meta-analytic CI showed neither a benefit of doing CBT nor a
equated to an absolute reduction of −1.40 (95% CI = −2.63 to −0.16) lack of benefit of doing CBT. The other two trials73,82 were not meta-
migraine days per month. We also note that the trial compared a analyzable, and both reported statistically nonsignificant effects.
combination of CBT, relaxation training, and propranolol with pro- Our meta-analysis of two trials of migraine disability (Figure 6B,
pranolol alone. The combination of the behavioral and pharmaco- combining data from 53 patients) was inconclusive (SMD = −0.24,
logic interventions was superior to the pharmacologic intervention 95% CI = −1.05 to 0.57). One other trial reported this outcome,76 and
alone, with an SMD of −2.63 (95% CI = −3.11 to −2.14) for attack the two groups' pre–post CIs largely overlapped, suggesting no sta-
frequency. tistically significant difference. Only Cottrell et al. (2007)76 reported
|

F I G U R E 5 Meta-analyses of mindfulness-based therapy in adults. (A) Migraine or headache frequency. (B) Migraine disability. B,
biofeedback; CBT, cognitive behavioral therapy; CI, confidence interval; E, education; Epi, only patients with episodic migraine; HA d/w,
headache days per week; HA/d, headaches per day; HA/w, headaches per week; HDI, Headache Disability Inventory; MBSR, mindfulness-
based stress reduction; Mi/w, migraine attacks per week; Mix, both episodic and chronic patients; NA, not applicable; NR, not reported; PDI,
Pain Disability Inventory; R, relaxation training; SMD, standardized mean difference; TAU, treatment as usual.

migraine-specific QoL (MSQ for adolescents), and both groups had Relaxation training
improved, with no statistical comparison reported between groups.
We included nine trials that measured the effectiveness of relaxa-
tion training for children/adolescents. For migraine/headache attack
Biofeedback frequency, we meta-analyzed five trials of relaxation in children/
adolescents (Figure 8A, combining data from 154 patients). The
We included four trials that measured the effectiveness of bio- result was inconclusive (SMD = −0.13, 95% CI = −0.48 to 0.21).
feedback for children/adolescents. All four reported migraine/ Three other trials reported data on this outcome. Two73,79 found a
headache attack frequency, but only two had calculable effect statistically nonsignificant effect. Labbé80 did not report sufficient
sizes, which were meta-analyzed (Figure 7, combining data from information for the calculation of effect sizes but did report that a
54 patients). The resulting SMD (−0.01, 95% CI = −0.55 to 0.52, three-group test (relaxation training only, biofeedback + relaxation
τ 2 = 0) was inconclusive. Neither of the other two trials, Labbé 80 training, waitlist control) was statistically significant. The relaxation-
79
and Labbé and Williamson, reported dispersion, but both found only group had reduced the average migraine frequency from 3.67 at
statistically significantly lower frequencies after treatment in the baseline to 0.38 at 1 month after the end of treatment, whereas the
biofeedback group. One other trial reported this outcome,76 and waitlist control group had a baseline mean of 3.18 with a 1-month
the two groups' pre–post CIs largely overlapped, suggesting no follow-up mean of 2.17.
76
statistically significant difference. Only Cottrell et al. reported Two trials reported enough information for calculable effect sizes
migraine-specific QoL (MSQ for adolescents), and both groups of migraine disability, which we meta-analyzed (Figure 8B, combining
had improved, with no statistical comparison reported between data from 53 patients). The result was inconclusive (SMD = −0.24, 95%
groups. CI = −1.05 to 0.57, τ 2 = 0.18, corresponding to a MIDAS difference of
|

TA B L E 4 Other comparisons with insufficient evidence.

Population Comparison Trial

Adults CBT vs. relaxation training Sorbi et al. (1986)62,63

Adults Relaxation training vs. biofeedback Reich (1989)53
Adults Relaxation training vs. MBSR meditation Wachholtz et al. (2008)67,68
Adults MBSR vs. education Wells et al. (2021)69
Adults Relaxation training vs. ACT Dindo et al. (2020)31
Adults EMG biofeedback vs. thermal biofeedback Sargent et al. (1986)56,57
Adults Relaxation training using PMR vs. relaxation using autogenic training Janssen and Neutgens (1986)39
Adults MBSR using guided imagery of scene details vs. relaxation using Brown (1984)25
guided imagery and relaxing statements
Adults MBSR meditation spiritual vs. internally focused secular vs. externally Wachholtz et al. (2008)67,68
focused secular
Adults Biofeedback vs. topiramate de Tommaso and Delussi (2017)30
Adults Relaxation training vs. topiramate Varkey et al. (2011)65
Adults CBT + relaxation training + education vs. relaxation Klan et al. (2022)15
Adults MBSR vs. stress management training + education Seminowicz et al. (2020)58
Adults Adding CBT to relaxation training and education Fritsche et al. (2010)33
Adults Adding biofeedback to CBT and relaxation training Sorbi and Tellegen (1984)61
Adults Adding biofeedback to relaxation training Sargent et al. (1986)56,57
Pediatric CBT vs. biofeedback Gerber et al. (2010)78
Pediatric CBT vs. relaxation training Richter et al. (1986) 83
Pediatric Biofeedback vs. relaxation training vs. metoprolol Sartory et al. (1998) 84
Pediatric Adding biofeedback to relaxation training Labbé et al. (1995) 80
Pediatric Adding education to biofeedback Allen & Shriver (1998)74

Note: See the full report for details on these comparisons.

Abbreviations: ACT, acceptance and commitment therapy; CBT, cognitive behavioral therapy; EMG, electromyographic; MBSR, mindfulness-based
stress reduction; PMR, progressive muscle relaxation.

6 points, 95% CI = −28 to 15). One other trial reported this outcome,76 All other effectiveness comparisons for children/adolescents
and the two groups' pre–post CIs largely overlapped, suggesting no were insufficient to permit conclusions (see Table 4 and the full
statistically significant difference. Only Cottrell et al.76 reported report).
migraine-specific QoL (MSQ for adolescents), and both groups had
improved, with no statistical comparison reported between groups.
Pediatric: Component contributions

Pediatric: Comparative effectiveness Both comparisons in this category (the effect of adding biofeedback
and the effect of adding education) were insufficient to permit con-
CBT + biofeedback + relaxation training versus clusions. See Table 4 and the full report for details.
education

Powers et al. 81 compared a combination of CBT, biofeedback, and DISCUSSION

relaxation training with education alone (both groups received
amitriptyline). For migraine attack frequency, there was a statis- Behavioral therapies can be used as standalone treatments or
tically significant difference between groups (corresponding to combined with other types of therapies (e.g., pharmaceutical, neu-
a difference in migraine days per month of −1.6, 95% CI = −2.7 romodulation) for migraine prevention. Some patients may have
to −0.4). The same advantage occurred in migraine disability as contraindications to medication or a preference against them (po-
measured by Pediatric Migraine-S pecific Disability Assessment tentially due to a desire to avoid the risk of adverse effects and/
(difference of −14, 95% CI = −25 to −3). Use of amitriptyline in or to general beliefs about pharmaceuticals). Thus, behavioral inter-
both groups may have affected the observed difference between ventions represent a critical alternative. We included 50 randomized
treatment groups. trials with adults and 13 with children and adolescents published
|

F I G U R E 6 Meta-analyses of cognitive behavioral therapy in children/adolescents. (A) Migraine or headache frequency. (B) Migraine
disability. B, biofeedback; CBT, cognitive behavioral therapy; CI, confidence interval; E, education; Epi, only patients with episodic migraine;
HA d/w, headache days per week; HA/2 w, headaches per 2-week period; HA/w, headaches per week; Mi/w, migraine attacks per week;
Mix, both episodic and chronic patients; PedMIDAS, Pediatric Migraine Disability Assessment; R, relaxation training; SMD, standardized
mean difference; TAU, treatment as usual.

F I G U R E 7 Meta-analyses of biofeedback in children/adolescents. (A) Migraine or headache frequency. (B) Migraine disability. B,
biofeedback; CBT, cognitive behavioral therapy; CI, confidence interval; E, education; Epi, only patients with episodic migraine; HA/2
w, headaches per 2-week period; Mi/w, migraine attacks per week; NA, not applicable; R, relaxation training; SMD, standardized mean
difference.

since 1978 that provided data on various behavioral interventions challenges, but in consultation with experts, we chose a consistent
for migraine prevention. strategy to yield a comprehensive portrait of the evidence. Our
The trials varied greatly in the specific behavioral component(s) evidence-based conclusions appear in Table 5.
employed, the nature of control or comparison groups used, and the Notably, we found sufficient evidence for the effectiveness of
outcomes assessed. The high variation presented numerous analytic some behavioral interventions for migraine prevention. Specifically,
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F I G U R E 8 Meta-analyses of relaxation training in children/adolescents. (A) Migraine or headache frequency. (B) Migraine disability. B,
biofeedback; CBT, cognitive behavioral therapy; CI, confidence interval; E, education; Epi, only patients with episodic migraine; HA d/w,
headache days per week; HA/2 w, headaches per 2-week period; HA/w, headaches per week; Mi/w, migraine attacks per week; Mix,
both episodic and chronic patients; PedMIDAS, Pediatric Migraine Disability Assessment; R, relaxation training; SMD, standardized mean
difference; TAU, treatment as usual.

in adults, low SOE suggests that behavioral interventions that in- biofeedback to propranolol, amitriptyline, and their combination, and
clude any of three components (CBT, relaxation training, and/or a fourth study38 had mixed results. As context, we note that a recent
mindfulness-based therapies) may lower migraine/headache attack systematic review found that calcitonin gene-related peptide antag-
frequency to a greater extent than usual care. The estimated reduc- onists, a well-established class of medications for migraine preven-
tion was approximately 1 migraine day/month but could be as low tion, reduced migraine days/month by only approximately 2 migraine
as 0.2 days/month or as high as 1.8 days/month. We also found that days/month (estimated advantage beyond placebo).86
education alone may improve migraine-related disability, based on Beyond attack frequency, it is important to determine whether
three trials (SOE: low; effect size not estimable due to insufficient behavioral interventions also reduce disability and/or improve qual-
reporting). For children/adolescents, the evidence was sufficient to ity of life. Many trials reported disability data, typically using the
conclude that CBT + biofeedback + relaxation training may reduce MIDAS and/or HIT-6. However, the data were too sparse and/or in-
migraine attack frequency and disability more than education alone consistent to permit conclusions (see Figures 2B, 3B, 4B, and 5B).
(SOE: low). Migraine-specific QoL data were less often reported and were also
A reduction of 1 migraine day/month was the minimum clinically inconclusive (see Figures 2C and 4C). Thus, future trials are needed
important difference identified a priori by our technical experts. Our to assess the impact of behavioral interventions on these important
point estimates for this outcome, therefore, were on the border of outcomes. Many behavioral trials have measured additional con-
clinical importance. When we examined direct evidence comparing structs such as improvements in depressive and anxious sympto-
behavioral interventions to medication, we found that two studies30,65 mology, self-efficacy, catastrophizing, locus of control, stigma, and
reported inconclusive data comparing biofeedback or relaxation to other aspects of functioning and well-being; these were not within
topiramate, another study45 reported inconclusive data comparing scope for this review.
HEADACHE

TA B L E 5 Summary of conclusions.

Comparison Outcome Amount of evidence Evidence favors Estimated difference SOE

15,26,29,38,41,42,54,59,60,70
Adults: behavioral intervention Migraine/headache attack frequency 10 RCTs (all 10 in CBT component 1.1 fewer migraine Low
that includes CBT vs. control meta-analysis) days/month (95%
CI = 0.4–1.8)
Adults: behavioral intervention Migraine/headache attack frequency 17 RCTs15,23,26,28,32,36–38,41,42,46,48,50,51,54,56,70 (13 Relaxation training component 1 fewer migraine Low
that includes relaxation training in meta-analysis) day/month (95%
vs. control CI = 0.4–1.6)
Adults: Behavioral intervention Migraine/headache attack frequency 5 RCTs25,29,42,59,60 (all 5 in meta-analysis) MBSR component 1 fewer migraine Low
that includes MBSR vs. control day/month (95%
CI = 0.2–1.8)
Adults: education alone vs. Migraine-related disability 3 RCTs22,55,64 (no meta-analysis) Education alone NC Low
control
Adults: MBSR vs. education Migraine-related disability 1 RCT69 MBSR 18 points on the Low
MIDAS (95% CI = 7–30)
Adults: CBT + relaxation training Migraine/headache attack frequency 1 RCT38 Propranolol 1.4 fewer migraine Low
vs. propranolol day/month (95%
CI = 0.2–2.6)
Adults: CBT + relaxation training Migraine-specific QoL 1 RCT38 CBT + relaxation training 12 points on the MSQ Low
vs. propranolol scale (95% CI = 7–18)
Adults: MBSR vs. stress Migraine/headache attack frequency 1 RCT58 MBSR 2 fewer migraine Low
management training + days/month (95%
education CI = 0.8–3.5)
Adults: CBT + relaxation training Migraine/headache attack frequency 1 RCT43 Biofeedback 2.2 fewer migraine Low
vs. biofeedback days/month (95%
CI = 0.1–4.4)
Pediatric: CBT + biofeedback + Migraine/headache attack frequency 1 RCT81 CBT + biofeedback + relaxation 1.6 fewer migraine Low
relaxation training vs. education training days/month (95%
CI = 0.4–2.7)
Pediatric: CBT + biofeedback + Migraine-related disability 1 RCT81 CBT + biofeedback + relaxation 14 points on the Low
relaxation training vs. education training PedMIDAS (95%
CI = 3–25)

Abbreviations: CBT, cognitive behavioral therapy; CI, confidence interval; MBSR, mindfulness-based stress reduction; MIDAS, Migraine Disability Assessment; MSQOL, migraine-specific quality of life;
MSQ, Migraine-Specific Quality of Life Questionnaire v2.1; NC, not calculable; PedMIDAS, Pediatric Migraine Disability Assessment; QoL, quality of life; RCT, randomized controlled trial; SOE, strength of
the evidence.
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“Low” SOE ratings mean we have limited confidence in the meth- included in the CBT analyses. However, our effectiveness analyses
odology and/or results of trials included in our analyses, primarily due did not incorporate the time or intensity of each component within
to concerns about study biases (e.g., differential expectations that are a treatment package. Thus, for consistency with how we analyzed
challenging to control for in the context of behavioral interventions, other treatment packages, we included MBCT in both the mind-
loss to follow-up), reporting, and/or the reliability of findings from fulness analyses and the CBT analyses. Fourth, we only included
small or inconsistent studies. The “low” rating should not be inter- randomized trials, and there may have been well-controlled nonran-
preted to mean that there is only a small benefit or no benefit. domized comparisons that would bolster the overall evidence.
Our findings require a few important qualifications. The first Our analysis and intervention classification were further compli-
concerns our analyses for effectiveness based on “any presence of cated by the varying terminology used by different researchers since
this component.” This nonspecific but consistent approach allowed 1975. Researchers could have used different terms for the same
us to indirectly estimate the effectiveness of a given component, component, or the same term for different components, and may
but other components in the packages may also have influenced have included components that they did not list in the publication.
outcomes. For example, interventions including CBT were primar- We categorized guided imagery as an MBSR intervention for adults
ily composed of CBT combined with other behavioral components; on the advice of one expert, and this may have affected outcomes.
however, a 2010 trial by Holroyd et al. 38 included two behavioral Another limitation of the date restriction (ours was 1975 and later) is
intervention arms, both of which received CBT and relaxation that some earlier trials may have been conducted according to trial
training, and one of which also received propranolol. Thus, for CBT, standards at the time, and the early trial results convinced most prac-
these findings not only reflect synthesis across trials with variable titioners that no more trials were necessary. This would result in few
types of behavioral components but also reflect the impact of re- trials captured by our 1975+ search, thereby reducing the chance
laxation training and propranolol, a pharmacologic intervention es- of reaching any conclusions about early treatments. This problem
timated to reduce migraine frequency by 0.8 days/month. 87 may have contributed to our judgments of insufficient evidence on
Second, few trials compared intervention with attention control. biofeedback. Note, however, that even after 1975, we included 13
For example, although we included 11 trials that included a CBT com- biofeedback trials with inactive controls. Eligibility criteria were also
ponent, only one42 of them had an attention control group, whereas limited to countries rated as very high on the Human Development
the other 10 compared CBT to waitlist or usual care or no interven- Index, which enhance applicability of findings to those settings but
tion. It is difficult to develop and administer an active behavioral excludes data from potentially relevant countries. Beyond a com-
control condition that does not have any therapeutic benefit, but prehensive search, we did not contact authors for more information
future trials should explore control groups that avoid the influence about their publications or for unpublished or additional data.
of expectations. Regarding attention controls, Rains and Penzien88 Intervention intensity (e.g., number of sessions per week, num-
discussed potential “psychological placebos” or “pseudotherapies” ber of hours per session) varied widely across the included trials
to use as inactive controls, the difficulty in credibly implementing (see the full report for details), and our analyses did not consider
them, and issues with critical appraisal of behavioral trials focusing on whether effect sizes varied by intensity. If a study had “underdosed”
blinding. They criticized the Jadad scale in particular, and that points patients (which in this context would mean that not enough behav-
on this scale are immediately lost due when blinding is not possible. ioral sessions were completed), that could explain the insufficiency
Our risk-of-bias approach, by contrast, utilized a more recently devel- of evidence on whether the treatment worked. We categorized ed-
oped scale20 that focused more on the underlying issues blinding is ucational interventions, when they were intended to influence be-
trying to prevent, rather than just to answer whether it was blinded. havior and/or ways of thinking, as an active intervention (not as an
These issues mostly involve differential expectations of benefit with inactive control group), and some may feel that “behavioral interven-
patient-provided subjective outcomes in an unblinded study. When tions” should not encompass any purely educational intervention.
the control group was simply on a waitlist, they knew they were not However, we defined behavioral interventions as nonpharmaco-
being treated, whereas the experimental group knew they were re- logic strategies intended to modify behavior and/or ways of think-
ceiving a potentially beneficial treatment, and the subjectively re- ing, which was based on consultation with numerous experts in the
ported outcomes may have been better in the latter group partially as field. We note that some trials had used passive education (i.e., not
a result of this differential expectation. By contrast, when the control intended to influence behavior or ways of thinking), and we catego-
was receiving a different active treatment in an active comparison rized those as inactive control. Finally, race and ethnicity were con-
study, such differential expectations are less of a concern (and there sistently underreported, and such reporting would enhance efforts
were many active-comparison trials for which we did not downgrade to improve representativeness and reduce health disparities.
risk of bias due to this particular concern). Other risk-of-bias concerns
(e.g., inadequately described randomization process, lack of conceal-
ment of allocation, incomplete data) were still frequent. Conclusions
Third, we recognize that MBCT is primarily a mindfulness-based
treatment, combined with elements of cognitive therapy, and not a Our analyses suggest that for adults, CBT, relaxation training, and
full CBT protocol. Thus, one might argue that it should not have been mindfulness-based therapies may each reduce the frequency of
|

migraine/headache attacks, and education may reduce disability. (Steven Baskin, PhD, Larry Charleston, MD, Michelle Clementi, PhD,
For youth, CBT + biofeedback + relaxation training may reduce mi- Christopher Gottschalk, MD, Karen Lee, MD, Richard B. Lipton, MD,
graine attack frequency and disability. The literature is comprised Tonya Palermo, PhD, Terri Pigott, PhD, and Jason Sico, MD) provided
mostly of multicomponent trials with smaller sample sizes than most helpful advice (their inclusion in this list does not imply endorsement
pharmacologic efficacy studies, which were not reported according of any statements in this article). Finally, we appreciate the assistance
to current reporting guidelines but may have followed recommen- of ECRI employees Lindsey Miller, (project management), Kristy
dations or norms for studies of behavioral therapies in place at the McShea, MLS (searching), Helen Dunn, MS (database management),
time. Future research should enroll children/adolescents, standard- and Katherine Donahue (references and document procurement).
ize intervention components when possible to improve reproduc-
ibility, although smart study designs may also be very helpful in F U N D I N G I N FO R M AT I O N
personalizing therapies, use noninterventional comparison groups This report is based on research conducted by the ECRI-Penn
when possible (such as attention control) that control for expecta- Evidence-Based Practice Center under contract to Agency for
tion confounds, enroll and retain larger samples including multisite Healthcare Research and Quality (AHRQ), Rockville, Maryland (con-
studies, study digital and telehealth modes of care delivery, consider tract 75Q80120D00002/Task Order 75Q80122F32006). Patient-
economic outcomes from patient perspectives, and follow current Centered Outcomes Research Institute (PCORI) funded the report
most rigorous guidelines and standards for data reporting. Future (PCORI publication 2023-SR-03). Funders were kept informed
funding should be established to test behavioral therapies with throughout the review process regarding the scope and the findings.
rigorous designs, and methodological and reporting guidelines for The findings and conclusions are those of the authors, who are re-
the conduct of behavioral clinical trials should be updated to match sponsible for the article's contents; the findings and conclusions do
contemporary expectations while still taking into consideration the not necessarily represent the views of AHRQ or PCORI. Therefore,
unique issues and needs of behavioral trials. no statement in this report should be construed as an official posi-
tion of PCORI, AHRQ, or the US Department of Health and Human
AU T H O R C O N T R I B U T I O N S Services.
Jonathan R. Treadwell: Data curation; formal analysis; funding ac-
quisition; investigation; methodology; project administration; su- C O N F L I C T O F I N T E R E S T S TAT E M E N T
pervision; validation; visualization; writing – original draft; writing Jonathan R. Treadwell, Amy Y. Tsou, Ilya Ivlev, Julie Fricke, Nikhil K.
– review and editing. Amy Y. Tsou: Conceptualization; data curation; Mull, and Benjamin Rouse declare no conflicts of interest. Dawn C.
funding acquisition; investigation; methodology; supervision; vali- Buse has been a consultant to Amgen, AbbVie, Biohaven, Collegium,
dation; visualization; writing – review and editing. Benjamin Rouse: Lilly, Lundbeck, Theranica, and Teva. She is a part time employee
Conceptualization; data curation; formal analysis; investigation; of Vector Psychometric Group. Scott W. Powers provides scien-
methodology; validation; visualization; writing – original draft; writ- tific consultation to Theranica. Mia Minen is a codeveloper of the
ing – review and editing. Ilya Ivlev: Data curation; formal analysis; in- RELAXaHEAD application, co-owned by NYU and Irody. Christina
vestigation; methodology; validation; visualization; writing – original L. Szperka or her institution have received compensation for serv-
draft; writing – review and editing. Julie Fricke: Data curation; for- ing as a consultant for Teva, Lundbeck, AbbVie, and Impel. She has
mal analysis; investigation; methodology; validation; visualization; received personal compensation for serving on a data safety moni-
writing – original draft; writing – review and editing. Dawn C. Buse: toring board for Eli Lilly and Upsher-Smith.
Conceptualization; supervision; writing – review and editing. Scott
W. Powers: Conceptualization; supervision; writing – review and ed- ORCID
iting. Mia Minen: Conceptualization; supervision; writing – review Jonathan R. Treadwell https://orcid.org/0000-0001-9848-2869
and editing. Christina L. Szperka: Conceptualization; supervision;
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|

86. Alasad YW, Asha MZ. Monoclonal antibodies as a preventive

therapy for migraine: a meta-analysis. Clin Neurol Neurosurg. S U P P O R T I N G I N FO R M AT I O N
2020;195:105900. Additional supporting information can be found online in the
87. Tsou AY, Rouse B, Bloschichak A, Treadwell JR. Drugs and Devices Supporting Information section at the end of this article.
for Migraine Prevention: Interactive Evidence Maps (Prepared by
ECRI Under Contract No. IDIQ-TO#12-ECRI-SCI-E VIDENCEMAP-
2019-07-15). Patient-C entered Outcomes Research Institute;
2021.
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2005;45:479-486. 2025;65:668-694. doi:10.1111/head.14914

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Received: 21 February 2024 | Accepted: 6 January 2025

Behavioral interventions for migraine prevention: A systematic

Jonathan R. Treadwell PhD1 | Amy Y. Tsou MD1 | Benjamin Rouse MS1 |

668 | wileyonlinelibrary.com/journal/head wileyonlinelibrary.com/journal/head Headache. 2025;65:668–694.

I NTRO D U C TI O N such as mindfulness-­based therapies (mindfulness-­based cognitive

TA B L E 1 Trial eligibility criteria.

Aspect Inclusion Exclusion

Aspect Inclusion Exclusion

Aspect Inclusion Exclusion

Episodic, chronic, or Comparative Components

Aguirrezabal (2019)22 116 NR • Education TAU or no intervention ✓

Episodic, chronic, or Comparative Components

Episodic, chronic, or Comparative Components

Simshäuser (2022)60 54 100% Episodic • MBCT TAU or no intervention ✓

Episodic, chronic, or Comparative Component

Adults: Comparative effectiveness

TA B L E 4 Other comparisons with insufficient evidence.

Population Comparison Trial

Adults CBT vs. relaxation training Sorbi et al. (1986)62,63

Note: See the full report for details on these comparisons.

Powers et al. 81 compared a combination of CBT, biofeedback, and DISCUSSION

Comparison Outcome Amount of evidence Evidence favors Estimated difference SOE

86. Alasad YW, Asha MZ. Monoclonal antibodies as a preventive

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668 | wileyonlinelibrary.com/journal/head wileyonlinelibrary.com/journal/head Headache. 2025;65:668–694.

I NTRO D U C TI O N such as mindfulness-based therapies (mindfulness-based cognitive