HEADACHE CURRENTS—CLINICAL REVIEW
Behavioral and Mind/Body Interventions in Headache:
Unanswered Questions and Future Research Directions
Rebecca E. Wells, MD, MPH; Todd A. Smitherman, PhD; Elizabeth K. Seng, PhD; Timothy T. Houle, PhD;
Elizabeth W. Loder, MD, MPH
Background.—Many unanswered questions remain regarding
behavioral and mind/body interventions in the treatment of
primary headache disorders in adults.
Methods.—We reviewed the literature to ascertain the most
pressing unanswered research questions regarding behavioral and
mind/body interventions for headache.
Results.—We identify the most pressing unanswered research
questions in this field, describe ideal and practical ways to
address these questions, and outline steps needed to facilitate
these research efforts. We discuss proposed mechanisms of action
of behavioral and mind/body interventions and outline goals for
future research in this field.
Conclusions.—Although challenges arise from the complex
nature of the interventions under study, research that adheres to
published study design and reporting standards and focuses
closely on answering key questions is most likely to lead to
progress in achieving these goals.
Key words: alternative medicine, headache, mind/body
Abbreviations: CAM complementary and alternative medicine, TTH
Non-pharmacological interventions have long been perceived
by patients and providers as beneficial for headaches, and
strong evidence supports the useful effects of certain non-
pharmacological interventions for migraine and tension-type
headache (TTH). The US Headache Consortium Guidelines for
prevention of migraine identified Grade A evidence to support
several specific non-pharmacological interventions including
relaxation training, thermal biofeedback combined with relax-
ation training, electromyographic (EMG) biofeedback, and cog-
nitive behavioral therapy (CBT)1(labeled as “evidence-based
behavioral interventions” for this paper). The combination of
preventive drug therapy and evidence-based behavioral therapies
was identified as having Grade B evidence for producing added
clinical benefit, although data published since these guidelines
were issued is likely to change the evidence to Grade A when the
guidelines are updated.2,3
In addition to evidence-based behavioral interventions, a
recent study found that more than 50% of US adults with
migraines/severe headaches reported having used complementary
and alternative medicine (CAM) techniques, most commonly
“mind/body therapies” such as meditation and yoga.4Thus,
although data most strongly support evidence-based behavioral
interventions, it seems that mind/body interventions are used
frequently by adults with primary headache disorders. Despite
their use, many unanswered questions remain regarding these
non-pharmacological interventions in the treatment of primary
headache disorders in adults. In 2005, Headache published an
entire series of peer-reviewed papers (many cited in this review)
that provided in-depth analysis of numerous methodological
issues and suggested solutions in behavioral headache research.
Given the increased utilization of mind/body therapies and
potentially similar underlying mechanisms between evidence-
based behavioral interventions and mind/body therapies, the goal
of this paper is to identify the most pressing unanswered research
questions in the field overall, describe ideal and practical ways
to address these questions, and outline steps needed to facilitate
these research efforts. We limit this discussion to the use of
evidence-based behavioral interventions and mind/body inter-
ventions to treat the primary headache disorders of migraine and
TTH in adults, as these headaches disorders are most prevalent in
the population and the ones to which non-pharmacological
interventions are most commonly applied. Other interventions
that are sometimes referred to as non-pharmacological interven-
tions, such as acupuncture or the use of herbal or dietary supple-
ments, are beyond the scope of this paper.
We conceptualize the differences between evidence-based
behavioral interventions and mind/body interventions for head-
ache across two domains, evidence-based and patient utilization.
Historically, most non-pharmacological interventions used and
studied in the treatment of headache have been behavioral or
cognitive behavioral interventions that focus on teaching specific
behaviors or skills to manage modifiable factors or behavioral
patterns in a person’s life (eg, stress, sympathetic arousal, mal-
adaptive thought processes) that may aggravate or trigger
headaches. Evidence-based behavioral interventions include
relaxation training (ie, deep breathing, progressive muscle relax-
ation training, and imagery); biofeedback training (thermal for
migraine or EMG for TTH); and CBT (sometimes termed
“stress management training”). These interventions have such
Conflict of Interest: None.
From the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC,
USA (R.E.Wells); Department of Psychology, University of Mississippi, Oxford, MS, USA (T.A.
Smitherman); Ferkauf Graduate School of Psychology, Yeshiva University, New York, NY, USA;
Albert Einstein College of Medicine of Yeshiva University, Bronx, NY (E.K. Seng); Department
of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA (T.T. Houle);
Department of Neurology, Brigham and Women’s Faulkner Hospital, Boston, MA, USA
Address all correspondence to R.E. Wells, MD, MPH, Department of Neurology, Medical
Center Blvd., Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.
Accepted for publication March 2, 2014.
© 2014 American Headache Society
strong evidence of efficacy for headaches that they are not
considered “alternative” approaches but instead standard non-
pharmacological treatments for headaches.5However, many
adults with headaches report using a broader array of “mind/
body” therapies that share a common intention “to enhance the
mind’s capacity to affect bodily functions and symptoms.”6These
mind/body therapies focus on the interplay between brain, body,
mind, and behavior, with specific attention to interactions
among emotional, mental, social, and spiritual factors and how
these influence health. These mind/body interventions some-
times incorporate components of evidence-based behavioral
interventions (eg, deep breathing, guided imagery) and interven-
tions with more limited evidence of efficacy in headache, such as
meditation, yoga, and tai chi.7-9
Access to headache-specific care is problematic for both types
of these non-pharmacological interventions. Despite the research
evidence supporting the benefits of evidence-based behavioral
interventions for headaches, access to behavioral providers
trained specifically to treat headache can be limited. Utilization
rates reported by patients tend to be relatively low (eg, less than
1% of the general US population with severe headaches/
migraines report using biofeedback), although techniques that
may not require a provider are being used more frequently (24%
of the same population report using deep breathing exercises).10
Further, many headache patients report using mind/body inter-
ventions, as 17% of the general US population with severe
headaches/migraines report doing meditation, and 9% report
doing yoga. However, these interventions are commonly used for
overall well-being rather than to target headaches specifically.
Despite the varying levels of evidence to support their use and the
varying levels of patient utilization, many key research questions
underlying both evidence-based behavioral and mind/body inter-
ventions need to be answered in order to move this field forward.
Key Unanswered Research Questions
Table 1 summarizes key unanswered research questions about
evidence-based behavioral and mind/body practices for adults
with common primary headache disorders. The questions are
divided into two main areas, content-based research questions,
and questions about the development and dissemination of
interventions. Perhaps the most pressing content-based-research
question is: “Which interventions are most helpful for headache
patients?” (Question #1, Q1) Although research studies have
demonstrated efficacy of evidence-based behavioral interventions
for migraine andTTH,1,2,11-15there are comparatively fewer effec-
tiveness studies that have evaluated treatment response in more
externally valid clinical practice settings.16Nash and colleagues
recommend a three-phase process to further answer this impor-
tant question, which sequentially involves pilot testing, then
efficacy testing, and finally effectiveness testing.16As roughly
one third of non-pharmacological studies compare an interven-
tion to no treatment or to a wait-list control,13,17future studies
with comparisons to alternative active treatments are needed,18
allowing different non-pharmacological interventions to be com-
pared against each other and providing insights into potential
mechanisms of action. More specifically, we need to understand
which techniques are most effective for specific types of patients
and headache disorders (ie, moderator variables) (Q1A),19as well
as the treatment components that account for the response (ie,
Many evidence-based behavioral and mind/body interventions
require a significant commitment to out-of-session time from
patients, and identification of the optimal “dose” of treatment
thus is essential (Q2). In order to recommend these interventions
for clinical use, we need to better understand how frequently
these interventions should be practiced, for how long, and over
what period of time in order to maximize clinical benefit and
minimize patient burden. For example, are classes lasting 2 hours
once a week more or less beneficial than a daily 15-min practice
session? Once a patient learns a technique, does it need to be
continually practiced to maintain benefit and if so, for how often
and how long? Numerous trials of evidence-based behavioral
interventions have demonstrated benefits that last for months or
even up to 5-7 years after the intervention ends.2,11,14,21-23It is
unclear, however, whether the persistent benefit results from the
initial teaching or continued regular practice. Many of the mind/
body intervention trials have not included long follow-up
periods,7,8and this remains an important issue for future research
on these interventions.
Table 1.—Unanswered Questions About Behavioral and Mind/
Body Practices for Adults With Primary Headaches
Content-Based Research Questions
1. Which interventions are most helpful for headache patients?
1A. Which types of patients and headaches are most responsive to
2. What is the optimal “dose” of these interventions? (eg, frequency,
duration, length of treatment)
2A. To what extent do patients need to be taught these
interventions by a professional, or can they learn them on
3. What are the putative mechanism(s) of action?
3A. What role do these interventions have on headache
4. What are the side effects and adverse events associated with
Development and Dissemination of Interventions
5. How can standardized protocols be made more accessible to
researchers and practitioners?
6. How can these interventions be better integrated into medical
practice settings for providers?
7. How can matching of appropriate treatment to patient responders
8. How can these practices be made more accessible and practical for
1108 | Headache | June 2014
Many trials have demonstrated that a minimal-therapist-
contact intervention can provide similar clinical benefit com-
pared to a more intensive clinic-based intensive treatment.24-31
Although additional studies are needed to better characterize the
efficacy of limited contact mind/body interventions in headache,
these approaches hold promise as ways to increase adherence,
reduce costs, and improve treatment accessibility in resource-
limited or remote areas. Since most evidence-based behavioral
and mind/body practices require a significant investment of time
by the patient, it is crucial to understand what level of interaction
with a trained professional is required for successful acquisition
of these skills, ranging from provision of online or written mate-
rials, to brief skills training in a medical office, to a more in-depth
course of treatment with a behavioral health-care provider or
mind/body instructor. (Q2A). There is some evidence of modest
benefit from treatment groups led by trained nonprofession-
als.32,33The shortage of behavioral headache treatment providers
within medical settings has likely contributed to the underuse of
evidence-based behavioral interventions, and training a larger
number of behavioral providers remains a significant need.
The physiological or psychological mechanisms that underlie
the effects of evidence-based behavioral and mind/body prac-
tices are not fully understood (Q3). Many are multi-component
interventions, and thus more than one mechanism may be
responsible for therapeutic effects; possible synergistic effects
among treatment components might explain particularly long-
lasting effects. Better understanding of the mechanisms of
action of these interventions would allow refinement and tar-
geting of treatments to improve clinical benefits, increase
patient/provider interest and adherence, and enhance scientific
credibility among those who view their benefits as resulting pri-
marily from nonspecific processes.34For example, it would be
helpful to understand how these interventions affect headache
threshold(s) (Q3A) in order to target interventions and under-
stand mechanisms of action. Specifically, such techniques may
increase the distance between an individual’s headache baseline
and headache threshold by (A) lowering the individual’s baseline
level of brain excitability; (B) raising an individual’s headache
threshold, or; (C) both (Figure).
The extensive research on evidence-based behavioral interven-
tions and growing research on mind/body practices indicates that
these treatments are generally acceptable, safe, and without sig-
nificant side effects.2,7,8,11-13,35However, anecdotal reports of mus-
culoskeletal injuries with certain types of yoga practices exist in
the media,36and rare case reports of meditation-induced psycho-
sis have been reported,37although recent studies have demon-
strated the benefit of mindfulness-based interventions even in
adults with psychosis.38-40Better reporting and understanding of
the potential harms, patient acceptability, and adverse events
associated with these practices are additional research priorities
and will facilitate comparisons of these treatments with conven-
tional medication treatments (Q4).
Another priority is the development, testing, publication, and
dissemination of standardized intervention protocols that are
feasible for use in clinical practice (Q5).41Treatment manuals are
not routinely published, presenting a barrier for widespread dis-
semination. Investigators and practitioners must continue to
work toward more consistency in treatment delivery methods
across studies to allow for cross-study comparisons and synthesis
for systematic reviews or meta-analyses. Despite extensive
research in this field, a lack of published treatment manuals
perhaps has hampered their dissemination and uptake in clinical
practice. Thus, publishing and openly distributing standardized
treatment manuals for behavioral and mind/body interventions
that can be easily applied in usual clinical settings is a significant
need (Q5). Research papers describing the effects of these inter-
ventions should provide, either in the paper’s methods section or
as an online appendix, sufficient detail about the treatment pro-
tocols used so that they can be replicated in further research.
Additionally, determining how these practices can be better inte-
grated into clinical practice so they are easily accessible to pro-
viders for routine headache care is crucial (Q6). Training health-
care providers to competently provide these services would likely
play an important role in this process. Being able to implement
clinically effective behavioral interventions outside of the
research context and finding the best ways to standardize dissemi-
nation to practitioners is a burgeoning area of research that needs
to be further addressed in the field of headache.16,42-45A number
of barriers can prevent patients from accessing and using
evidence-based behavioral and mind/body treatments for head-
ache.46As previously described, these interventions often require
a significant commitment of time, energy, and in some cases
financial resources, from patients. It is imperative to identify
Figure.—Possible mechanisms of action of behavioral and mind/body
treatments for headache. Behavioral and mind/body treatments may
exert their effects by increasing the distance between an individual’s
baseline and their headache threshold by (A) lowering the individual’s
baseline level of brain excitability; (B) raising an individual’s headache
threshold; or (C) both (not pictured). (Reproduced with permission
from the journal Headache.65)
1109 | Headache | June 2014
subgroups of patients most likely to respond to these treatments
in order to facilitate treatment matching and to avoid use in those
unlikely to benefit (Q7). Research aimed at identifying and
reducing treatment barriers is also critical to ensure that effective
treatments will be accessible and widely used (Q8).
Potential Mechanisms of Change of Behavioral and Mind/
Body Headache Treatments
Although the mechanisms that mediate the benefits of evidence-
based behavioral and mind/body interventions in adults with
headaches are not fully understood, many hypotheses have been
posited (Table 2). Psychological stress is among the most fre-
quently endorsed triggers of headache,47and interventions that
reduce stress or improve patients’ abilities to cope with stress are
integral in behavioral headache management. While stress reduc-
tion is one of the mechanisms most commonly evoked to explain
the beneficial effects of evidence-based behavioral and mind/
body interventions, how these practices lead to stress reduction is
unclear and may vary by intervention. Stress is thought to impact
headache by (1) directly impacting pain perception; (2) fostering
activation and sensitization of nociceptors over time; and (3)
worsening headache-related disability and quality of life. The
headache experience itself serves as a stressor that compromises
well-being.48Evidence-based behavioral and mind/body practices
may alter central pain processing. A study assessing experimental
pain during meditation showed that meditation decreased pain
unpleasantness by 57% and pain intensity by 40%.49Neuro-
imaging showed that these reductions were associated with
increased activity in the anterior cingulate cortex and anterior
insula (ie, areas involved in the cognitive regulation of nocicep-
tion) and with thalamic deactivation.49Meditation and other
non-pharmacological practices may activate natural endogenous
analgesic processes, or observed results could be attributable to
distraction or altered expectations.50Yet the exact physiological
mechanisms of stress-reducing interventions on headache are not
clearly elucidated. If stress-reducing interventions are effective
because they alter autonomic reactivity, it is important to deter-
mine whether they alter autonomic responses to individual stress-
ful events or the patient’s baseline autonomic levels.
Non-pharmacological interventions also may exert beneficial
effects by affecting psychological constructs. An increased sense
of headache “self-efficacy,” or confidence in one’s ability to persist
with behavioral change efforts that one believes will manage
headache symptoms, and a reduced external “locus of control,”
or belief that nothing can exert control over the onset and course
of headache, are potent predictors of behavioral treatment out-
comes. Foundational research on evidence-based behavioral
interventions decades ago identified increased self-efficacy as the
key mediator of successful EMG biofeedback for TTH, regard-
less of whether the patient was taught to increase or decrease
muscle tension.51More recent research has confirmed that both
self-efficacy and locus of control are important factors for the
success of evidence-based behavioral headache treatments.52
Evidence-based behavioral and mind/body interventions may be
useful also because they improve psychiatric conditions com-
monly comorbid with headache, such as anxiety and depression,
and are often associated with a poorer prognosis.53-55Improve-
ments in these affective conditions, even if present at a level not
warranting a clinical diagnosis, in turn may improve the ability to
cope with pain and enhance adherence to treatment recommen-
dations. Even adults without formal psychiatric diagnoses may
experience disabling anxiety related to the fear of individual
attacks, the fear of triggers, or at the onset of prodrome or aura.
This process of fearing the worst possible outcome (ie, catastro-
phizing) may prompt unwarranted avoidance behaviors that
further perpetuate pain and increase pain sensitivity over
time.56,57Evidence-based behavioral and mind/body practices
that directly or indirectly target these psychological factors can
teach patients more effective ways of coping with these fears.
As with their effects on psychiatric symptoms, evidence-based
behavioral and mind/body interventions may produce improve-
ments in headache by fostering other healthy lifestyle habits. Poor
sleep duration and quality are common headache triggers, and
some non-pharmacological interventions (eg, relaxation, stress
management, meditation) may improve sleep, which in turn may
mediate improvements in headaches.
interventions act through the complex mechanisms of placebo.
Other components that are unique to these interventions, such as
the rituals associated with such practices, the therapeutic alliance
between patient–provider, and the empathy provided by the
Table 2.—Proposed Mechanisms of Change for Behavioral and
Mind/Body Headache Treatments*
A. Stress reduction
Decreased stress hormones (eg, cortisol)
Altered autonomic arousal
B. Changes in relevant psychological constructs
Improved coping skills
Decreased external locus of control
Decreased pain catastrophizing
Decreased depression and anxiety
C. Effects on other behaviors
Improved diet, exercise, and other healthy behaviors
D. Change in pain processing
Change in neural pain processing
Activation of natural endogenous analgesic processes
“Common factors” (eg, ritual, empathy, alliance, etc.)
*See text for references.
1110 | Headache | June 2014
provider, may all have a powerful role in these interventions.58,59At
present, however, rigorous methodological attempts to tease apart
proportions of treatment improvement attributable to specific
techniques vs these “common factors” within the field of headache
migraine sufferers in which CBT plus amitriptyline was compared
with education plus amitriptyline.3Because therapist time and
attention were equivalent between groups, the finding that CBT
produced superior reductions in headache frequency and disability
suggest that a therapeutic relationship alone is unlikely to account
for differential treatment gains. To better clarify putative mecha-
nisms of action, clinical trials employing factorial and dismantling
designs are needed, as is a concerted effort by trials researchers to
include pre- and post-treatment assessment of relevant psychologi-
mind/body practices.18,46,60,61Double-blinded placebo-controlled
randomized clinical trials (RCTs) are the gold standard for assess-
ing clinical efficacy of an intervention, but double-blinded trials
are impossible in most non-pharmacological interventions, and
attempts at “psychological placebo controls” have been fraught
with logistical and interpretive challenges.18It is virtually impos-
sible to blind participants to allocation (with the possible excep-
tion of non-contingent biofeedback), and even in well-executed
single-blinded trials of behavioral interventions, blinding the
treatment provider is usually not feasible. Participant recruitment
and retention in RCTs present challenges for trials of long dura-
tion and because of limited availability of funding. As a result,
some studies of behavioral interventions have small sample sizes.
For example, the average number of subjects was 16 in a recent
meta-analysis of 55 biofeedback studies.14Such sample sizes may
be sufficient to address the principal outcome of interest, but may
be somewhat underpowered to address sensitivity analyses or
Despite these limitations, prior high-quality research studies of
behavioral treatments have been conducted, which culminated in
the aforementioned Grade A evidence rating for relaxation train-
ing, thermal biofeedback combined with relaxation training,
EMG biofeedback, and CBT.1Since then, a meta-analysis of 55
studies of biofeedback has confirmed that blood-volume-pulse
biofeedback also has strong efficacy for migraine.14Table 3
outlines suggested goals for future behavioral and mind/body
research trials. Guidelines for pharmacological trials of migraine
preventive treatments have been published by the International
Headache Society,62and some of those recommendations made
are applicable to trials of non-pharmacological interventions.
Given the methodological issues unique to non-pharmacological
studies, researchers should familiarize themselves with the
American Headache Society’s Guidelines for Trials of Behavioral
Treatments,63which provides numerous methodological recom-
mendations for conducting behavioral trials. Many, if not most,
of these recommendations apply also to mind/body interventions
in headache, although a similar guideline for mind/body inter-
ventions does not currently exist. These published resources
should be consulted early in trial design, since they identify many
aspects of trial design, outcome choices, and interpretation that
are unique to the field of headache.
When feasible, RCTs are desirable because of their method-
ological rigor (as compared to case reports, single-group longi-
tudinal or cohort studies, or cross-sectional studies). Crossover
designs are often not feasible because “erasing” the impact of a
learned skill is impossible, and carry-over effects are inevitable.To
ensure the highest level RCT designs, a number of criteria should
be met.63Control conditions should match for the time and
attention of the intervention group and be of sufficient impact
that participants have equal expectancy for positive outcomes
and treatment credibility. The intervention under investigation
needs to be of sufficient quality to uphold therapy integrity and
treatment fidelity, and patient adherence should be monitored
and reported. Assessment of treatment integrity and fidelity are
important, and researchers in other broader fields have published
methods and strategies for accomplishing this in clinical
trials.43,44Primary and secondary outcomes should be delineated
from the start of the trial, the trial should be registered in an
approved trial registry before the first participants are enrolled
(eg, clinicaltrials.gov), statistical procedures for handling drop-
outs should be clearly articulated, and the intervention should
be well described to enable replication.64The post-intervention
evaluation period must be long enough to detect and determine
the time course of change, in most cases a minimum of 3 months,
and, ideally, 12 months post-treatment. In addition to assess-
ments of efficacy, clinical trials that evaluate treatment modera-
tors and mechanisms of action are essential, given our limited
knowledge in this area.
Many patients with headache and headache medicine practitio-
ners use or recommend evidence-based behavioral interventions
Table 3.—Goals for Future Behavioral and Mind/Body
Randomized controlled trials
Adequate and appropriate controls
Intervention upholds therapy integrity and treatment fidelity is
Clear specification of primary and secondary outcomes
Appropriate handling of treatment dropouts
Post-intervention follow-up is of sufficient length
Assessments of potential mechanisms of action
Clear specifications of the intervention protocol
1111 | Headache | June 2014
and mind/body interventions to manage headache pain, but
many unanswered questions remain. In consideration of unique
methodological challenges that arise from the complex nature of
the non-pharmacological interventions under study, we have out-
lined key research questions and goals for future studies in hopes
of furthering the evaluation and dissemination of these interven-
tions for patients with primary headache disorders. Research that
adheres to published guideline recommendations and is designed
to properly answer key questions is most likely to lead to progress
in these goals.
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