Behavioral Headache Treatment: History, Review of theEmpirical Literature, and Methodological Critique

Jeanetta C. Rains, PhD; Donald B. Penzien, PhD; Douglas C. McCrory MD, MHS;Rebecca N. Gray, DPhil

Theoretical developments and burgeoning research on stress and illness in the mid-20th century yielded the foun-dations necessary to conceptualize headache as a psychophysiological disorder and eventually to develop and applycontemporary behavioral headache treatments. Over the past three decades, these behavioral headache treatments(relaxation training, biofeedback, cognitive-behavioral therapy, and stress-management training) have amassed asizeable evidence base. Meta-analytic reviews of the literature consistently have shown behavioral interventions toyield 35% to 55% improvements in migraine and tension-type headache and that these outcomes are significantlysuperior to control conditions. The strength of the evidence has lead many professional practice organizations torecommend use of behavioral headache treatments alongside pharmacologic treatments for primary headache. Thepresent overview was prepared as a companion article to and intended to provide a background for the Guidelinesfor Trials of Behavioral Treatments for Recurrent Headache also published within this journal supplement. Thisarticle begins with a synopsis of key historical developments leading to our current conceptualization of migraineand tension-type headache as psychophysiological disorders amenable to behavioral intervention. The evolutionof the behavioral headache literature is discussed, exemplified by publication trends in the journal Headache.Leading empirically-based behavioral headache interventions are described, and meta-analytic reviews examiningthe migraine and tension-type headache literatures are summarized, compared, and contrasted. A critique of themethodological quality of the clinical trials literature is presented, highlighting the strengths and weaknesses inrelation to recruitment and selection of patients, sample size and statistical power, the use of a credible control, andthe reproducibility of the study interventions in clinical practice.

Key words: behavioral, headache, biofeedback, stress management, review, methodology

Abbreviations: AHRQ Agency for Healthcare Research and Quality, AASH American Association for the Studyof Headache, AHS American Headache Society, EEG electroencephalogram, EMG electromyo-graphic, ICHD International Classification of Headache Disorders

(Headache 2005;45[Suppl 2]:S92-S109)

From the Center for Sleep Evaluation, Elliot Hospital, Manch-ester and Department of Psychiatry, Dartmouth Medical Cen-ter, Lebanon, New Hampshire (Dr. Rains); Head Pain Center,Department of Psychiatry and Human Behavior, University ofMississippi Medical Center, Jackson, Mississippi (Dr. Penzien);Center for Clinical Health Policy Research, Duke UniversityMedical Center, Durham, North Carolina (Drs. McCrory andGray); and Center for Health Services Research in PrimaryCare, Durham Veterans Affairs Medical Center Durham, NorthCarolina (Dr. McCrory).

Address all correspondence to Dr. Jeanetta C. Rains, ClinicalDirector, Center for Sleep Evaluation, Elliot Hospital, One El-liot Way, Manchester, NH 03103.

Behavioral headache treatments are rooted in theconceptualization of headache as a psychophysiologi-cal disorder (physical disorder influenced by psychoso-cial and environmental stressors). Such treatments tar-get the patient’s headache-related physiological re-sponses (relaxation training, biofeedback) or behav-iors, emotions, and cognitions (cognitive-behavioraltherapy, stress-management). A very substantial quan-tity of empirical research evaluating these treatmentshas been produced within the past three decades thatis largely an outgrowth of pioneering developmentsin biofeedback and psychophysiology in the 1970s—some deliberate and others serendipitous. This article

S92

Headache S93

provides a brief contextual framework as well as a re-view and critique of the empirical evidence for the be-havioral headache treatments that have now garneredwidespread acceptance as conventional treatments forrecurrent migraine and tension-type headache.

HEADACHE AS A PSYCHOPHYSIOLOGICDISORDER: HISTORY AND FOUNDATIONFOR BEHAVIORAL TREATMENT

Although the preponderance of the behavioralheadache research has materialized in the past 30years,1,2 the view of headache as a psychophysiologicaldisorder substantially predates contemporary behav-ioral research. This view was in fact well advanced byrenowned headache specialist Dr. Harold G. Wolff andcolleagues in the 1950s,3-6 influenced by the early workon stress and illness of Dr. Walter B. Cannon7,8 andDr. Hans Selye.9-11 The psychophysiologic view repre-sented a critical departure from a purely psychogenicor psychopathologic view of headache based on psy-choanalytic principles of psychosomatic medicine.12

Psychogenic causality posited that a psychosomatic ill-ness arose as a result of specific emotional conflictsexperienced in early childhood that in turn were as-sociated with specific organ systems and eventuallyproduced specific physical symptoms. The psychoso-matic formulation that the emergence of a psychoso-matic illness was predetermined by early interpersonalconflicts was supplanted by the contemporary concep-tion acknowledging that more generalized physiolog-ical responses to stress can contribute to a variety ofpsychophysiologic symptoms.

Cannon7,8 defined key processes that later provedfundamental to the contemporary understanding ofthe bodily response to stress; he articulated the “home-ostatic” function of the sympathetic nervous system inmaintaining a physiological steady state, and he de-scribed the “fight or flight” response—the innate abil-ity of a biological organism to mobilize in responseto threat. But it is Selye who is credited with intro-ducing and applying the concept of “stress” to biologyand medicine.9,10 In 1936, he published his earliest for-mulation of the stress theory.9 Referencing animal ex-periments, he described the general and stereotypedreaction of an organism to diverse noxious agents,which he later termed “stressors” (cold, injury, shock,

excessive exercise). The stereotyped hypothalamic-pituitary-adrenal response was characterized chrono-logically along three stages: alarm, resistance, and ulti-mately exhaustion. Selye noted, “Since the syndromeas a whole seems to represent a generalized effortof the organism to adapt itself to new conditions, itmight be termed the ‘general adaptation syndrome.’”(p. 32).9 Selye concluded that stress played some rolein the development of virtually every disease and thatfailure to cope with “stressors,” which can be any stim-uli, can result in “diseases of adaptation.”10

While Selye’s early work defined stressors as phys-ical events, Wolff offered a psychosocial formulationof the nature of stress,3 noting “man is further vulner-able because he reacts not only to the actual existenceof danger but to threats and symbols of danger” andbecause “he is a tribal or group creature . . . he is de-pendent for his very existence upon the aid, support,and encouragement of other men” (p. 1059). The the-sis of over two decades of Wolff’s work was that totruly understand psychophysiological disorders suchas headache, we must understand how psychosocialand physiological variables interact during stress toinduce symptoms. Toward this end, Wolff developedinnovative methods of observing psychological andphysiological responses as people responded to natu-ralistic stressors, or with cleverly designed laboratorystressors. He also vigorously pursued efforts to inte-grate knowledge from the social and medical sciencesthat would be necessary to this understanding. Themonograph Social Science and Medicine (co-authoredwith Leo Simmons) states Wolff’s thesis concisely: “Inour opinion, . . . it is the joint province of both so-cial and physical (medical) scientists to work on thecentral linkage, namely, how specified stresses workto evoke particular [psychophysiological] protectivereaction patterns” (p. 144–145).5 Wolff’s focus on psy-chophysiology (ie, the interaction of psychological andphysiological variables in generating headaches) andhis emphasis on the integration of relevant knowledgefrom the social and medical sciences would place himin the mainstream of behavioral medicine today.

The work of Wolff and others arguably reflecteda paradigm shift in medicine from a traditional mind-body dichotomy toward an integrative biopsychosocialperspective.13 Numerous journals emerged to record

S94 May 2005

the scientific investigation of behavioral/psychosocialprocesses in health and their role in the pathogen-esis and treatment of disease.14 The clinical field ofbehavioral medicine, within which most behavioralheadache specialists now practice, emerged as an “in-terdisciplinary field concerned with the developmentand integration of behavioral and biomedical science,knowledge, and techniques relevant to the under-standing of physical health and illness and the appli-cation of this knowledge and these techniques to pre-vention, diagnosis, treatment and rehabilitation.”15

PSYCHOPHYSIOLOGY ANDBIOFEEDBACK

Theoretical and technological advances in psy-chophysiology stimulated objective examination of re-lationships between the physiological and psycholog-ical processes, and lead to clinical applications for be-havioral regulation of neural and visceral processesthrough operant learning and biofeedback.16 The firstdemonstration of learned behavioral control overphysiologic responses was published in 1961, and inthe 1960s and 1970s human studies demonstrated thatthrough operant feedback methods, voluntary controlcould be learned over many physiologic responses (eg,heart rate, blood pressure, skin conductance, muscletension, skin temperature, evoked potentials, and var-ious rhythms of the electroencephalogram [EEG]).16

Keefe and colleagues17 reviewed foundations ofpsychophysiological studies of pain with the majorityof the earliest applications pertaining to headache in-cluding an early electromyographic (EMG) study bySimons and Wolff5 addressing mechanisms of post-traumatic headache. Interestingly, psychophysiologystudies contributed to the rise18 and fall of the notionthat migraine was a vascular phenomenon and tension-type headache was a musculoskeletal phenomenon.19

The first published demonstration of biofeed-back for tension headache treatment was conductedby Budzynski and colleagues who developed theEMG biofeedback model and protocol for ten-sion headache,20 and went on to demonstrate initialheadache improvements in uncontrolled21 and con-trolled22 experiments. Around the same time, ElmerGreen serendipitously discovered the application ofthermal biofeedback for migraine; a migraineur un-

dergoing thermal biofeedback for Raynaud’s Diseaseat the Menninger Clinic reported that she was ableto abort a headache at the time she was attemptingto increase blood flow to her hand and raise fingertemperature—this lead to the “hot hand” therapy formigraine.23

In the decade that followed, these initial demon-strations of the potential usefulness of biofeedback asviable form of headache therapy, in turn, stimulatedpublication of a host of small trials examining the roleof psychological and behavioral factors in precipitat-ing headache, further illustrating the value of a varietyof “nonpharmacological” or “behavioral” headachetreatments, and began examining their mechanisms ofaction (representative early papers include24-36). Asaddressed in detail below, the subsequent two decadeshave yielded increasingly more sophisticated empiricalresearch addressing the role and value of behavioralinterventions for headache.

BEHAVIORAL HEADACHE TREATMENTSIt was the fundamental shift in our conception

of headache (and other “psychosomatic disorders”)from psychogenic disorder to psychophysiological(or “stress-related”) disorder, which paved the wayfor application of behavioral treatments to primaryheadache conditions irrespective of psychopathology.In most instances, behavioral interventions includestrategies for: (i) identification and modification ofbehavioral headache triggers, and (ii) acquisition anduse of physiological self-regulation skills aimed at pre-vention of headache episodes as opposed to abort-ing an acute headache. Standard behavioral inter-ventions can be broadly categorized as: relaxationtraining, biofeedback training, cognitive-behavioraltherapy (ie, stress-management training), or somecombination or varied format of the above approaches.Most research has been carried out with adults but aliterature addressing special populations (ie, pediatric,elderly) is emerging.

Relaxation Training.—Relaxation skills are pre-sumed to decrease headache by enabling headachesufferers to modify their own headache-relatedphysiological responses and decrease sympatheticarousal. Three types of relaxation training have beencommonly employed for treatment for headache:

Headache S95

progressive muscle relaxation37-40; autogenic traininginvolving self instructions (such as warmth and heavi-ness) to promote a state of deep relaxation41; and med-itative or passive relaxation.42,43 A relaxation-trainingprotocol may consist of 10 or more treatment ses-sions, over time abbreviating and integrating the relax-ation skills into everyday responses until relaxation isachieved through simple recall and eventually becom-ing an automated response. Protocols include instruc-tions and materials for home practice. Relaxation tech-niques are often used in combination with biofeedbackand stress-management.

Autogenic training, as a form of relaxation train-ing for headache, has foundations in hypnosis.41 Hyp-nosis itself has also been applied to the treatment forheadache, as noted in several exemplary studies.44-46

In its classic formulation, hypnosis is thought to inducea state of highly focused concentration combined withsuspended peripheral awareness (ie, hypnotic trance),which presumably increases the patient’s receptive-ness to suggestion such as pain control.47,48 Hypnosisalso has been used to induce relaxation. Clearly, pro-fessional opinions differ dramatically regarding the na-ture and mechanisms of hypnosis. Hypnosis has beenutilized as a headache intervention in Europe morebroadly than in the United States. Whereas some pre-vious reviews of the behavioral headache treatment lit-erature have categorized hypnosis separately, other re-views have categorized hypnosis with relaxation train-ing; the latter approach was adopted in the presentreview.

Biofeedback Training.—Biofeedback involves tech-nologies to monitor physiological processes that areusually considered involuntary or that are modu-lated outside of conscious awareness (eg, muscle ten-sion, pulse, blood pressure, peripheral blood flow).Information about the physiological process is con-verted and amplified into a signal (visual or audi-tory) and then fed back to the individual. With bio-logical feedback or biofeedback, patients are able tolearn enhanced control over the physiological pro-cess [operant learning model]. The two most com-mon forms of biofeedback for headache have beenthermal biofeedback or “handwarming” for migraineand EMG biofeedback for tension-type headache.Other types of biofeedback training (eg, alpha en-cephalographic, cephalic vasomotor, electrodermal)

have been studied less frequently and they seldom areapplied clinically.

Early on, the specific dedicated applications ofthermal versus EMG biofeedback corresponded tovascular versus muscular pathophysiologies of mi-graine and tension-type headache presumed in the1960s and 1970s; these preconceptions regardingheadache pathophysiology have been generally dis-credited (in part by biofeedback research itself), andas discussed elsewhere19 the efficacy of biofeedbackis now understood to involve more complex thera-peutic processes than simple physiologic retraining.29

Biofeedback training often is facilitated by instructingpatients in relaxation or autogenic exercises. Biofeed-back training for headache may require a dozen ormore treatment sessions with patients typically in-structed to engage in daily home practice during treat-ment. Reliance upon the biofeedback device is grad-ually eliminated as the patient’s self-regulation skillsare consolidated.

Cognitive-Behavioral Therapy.—Cognitive-behav-ioral therapy and stress-management training aredescribed extensively elsewhere49-51 and essentiallyinvolve combining two psychological treatmentapproaches—cognitive therapy and behavior therapy.When used in combination, cognitive-behavioral treat-ments modify overt behavior by altering thoughts, in-terpretations of events, assumptions, and usual behav-ioral patterns of responding to events or stressors. Ap-plied to headache,52-54 these interventions alert pa-tients to the role of thought processes in stress re-sponses and the relationships between stress, coping,and headaches. Patients are assisted in identifying thespecific psychological or behavioral factors that trig-ger or aggravate their headaches, and taught to employmore effective strategies for coping with headache-related stress. Often, treatment is administered in con-junction with relaxation or biofeedback training forheadache, and requires from three to a dozen or moretreatment sessions.

Alternate Formats for Behavioral Treatment.—Be-havioral treatments usually have been administeredto patients by professionals in face-to-face weeklyclinic sessions, but more recently alternate formatshave been developed. In the 1980s, researchers becameincreasingly aware of drawbacks to intensive clinicbased and individually administered (or 1:1 behavioral

S96 May 2005

treatment delivery models) and began to consider is-sues of cost and efficiency. Minimal therapist-contacttreatments have been the most extensively examinedin this arena.55-57 Minimal-contact or “home-based”formats provide similar treatment components to theirclinic-based counterparts. However, skills are intro-duced in the clinic, but training occurs primarily athome guided by written materials and audiotapes.Consequently, only three or four clinic sessions maybe necessary when behavioral techniques are deliv-ered via this format versus the eight or more weeklyclinic sessions required for the standard clinic-basedformat. Group, Internet, and other novel administra-tions of behavioral treatments have been examined tosome extent and are discussed elsewhere.2

THE BEHAVIORAL HEADACHETREATMENT LITERATURE

The preponderance of empirical research evalu-ating these treatments has been produced within thepast three decades1,2 stimulated by the birth of be-havioral medicine and developments in psychophys-iology as noted above. With the overwhelming ma-jority of published clinical trials yielding positive out-comes, the evidence has led many professional prac-tice organizations to recommend use of behavioralheadache treatments alongside pharmacologic treat-ments for primary headache (see Table 1).

Interestingly, the American Headache Society’s(AHS) recognition of biofeedback as a valid formof headache therapy in 197858 endures as one of

Table 1.—Professional Organizations Formally EndorsingBehavioral Interventions for Recurrent Headache

American Academy of Family Physicians60,61

American Academy of Neurology60,61

American Headache Society 58,60,61

American College of Emergency Physicians60,61

American College of Physicians60,61,116

American Osteopathic Association60,61

American Medical Association117

Association for Advancement of Behavior Therapy118

Association for Applied Psychophysiologyand Biofeedback119

Canadian Headache Society120,121

National Institutes of Health122,123

National Headache Foundation60,61

World Health Organization124

the earliest formal endorsements of behavioral treat-ments by a medical organization, and it was forwardedwhile “behavioral medicine” as a discipline was inits infancy (p. 250).15 Also among the endorsementsof behavioral therapy for headache is an importantevidence-based treatment guideline produced by theU.S. Headache Consortium, a multidisciplinary assem-blage of seven professional practice organizations.59,60

Focused upon management of migraine by the primarycare practitioner, the guideline is available online inits entirety (http://www.aan.com/). The Consortium’srecommendations pertaining to behavioral interven-tions for migraine are: (i) relaxation training, thermalbiofeedback combined with relaxation training, EMGbiofeedback, and cognitive-behavioral therapy may beconsidered as treatment options for prevention of mi-graine (grade A evidence), and (ii) behavioral ther-apy may be combined with preventive drug therapyto achieve added clinical improvement for migraine(grade B evidence).61

GROWTH IN BEHAVIORAL HEADACHERESEARCH

For purposes of this review, trends were exam-ined in the evolution of behavioral and psychologicalheadache literature. While many behavioral headachestudies were published in a broad variety of journals(medicine, behavioral medicine, clinical psychology,pain), the subsample of studies published in Headachenevertheless exemplifies the major trends in the quan-tity and type of publications reporting behavioralheadache research. In order to appraise these trends,each issue of Headache from its inception in 1962through 2004 was examined. The review identifiedand categorized 383 papers (excluding conference ab-stracts) that specifically addressed behavioral, psychi-atric, and other psychological topics as at least part ofthe article’s principal focus. The behavioral and psy-chological literature published in Headache has grownsharply since the 1960s (Fig. 1).

A precipitous increase in the number of publica-tions was noted in the late 1970s with a more gradualbut continuing linear ascent in subsequent decades.Prior to 1970, only nonempirical papers and clinicalcommentary pertaining to psychological factors hadbeen published in Headache. The surge in research

Headache S97

Fig 1.—Number and type of study or report of behavioral/psychiatric/psychological papers published in Headache. Number andtype of report by 5-year period for papers addressing behavioral, psychiatric, and other psychological topics published in thejournal Headache between 1962 and 2004. A total of 383 papers [excluding conference abstracts] categorized and graphed by type:Psychophysiology; Tx-Controlled: treatment study controlled; Tx-Uncontrolled: treatment study uncontrolled; Assess./Psychopath.report includes assessment data pertaining to psychiatric disorders or psychopathology; Assess./Other: report includes assessmentdata pertaining to nonpsychiatric psychological factors (eg, stress, quality of life, disability); Commentary: nonempirical clinicalcommentary or expert opinion pertaining to behavioral, psychiatric disorders, psychopathology, or other psychological factors.

in the 1970s was accounted for by increased psy-chophysiology research and controlled clinical trials.Psychophysiology research peaked in the early 1980sand has subsequently declined. With respect to clin-ical trials research, the number of controlled trialshas increased while the number of uncontrolled tri-als has remained steady at a relatively small rate. Thenumber of studies examining nonpsychiatric psycho-logical variables has increased greatly in recent years.This burgeoning trend is largely (but not exclusively)accounted for by an increasing number of studiesdesigned to examine headache-related disability andquality of life. Over the years there has been a fairlysmall but steady stream of papers providing clinicalcommentary or editorial of psychiatric and behavioralissues.

EMPIRICAL REVIEWS OF THE CLINICALTRIALS LITERATURE

Meta-analytic reviews provide a quantitative, andin some cases qualitative, assessment of the sum ofthe behavioral headache literature and permit compar-isons to parallel literatures assessing standard pharma-

cologic headache treatments. Meta-analysis has beenused extensively in recent years in evidence-basedmedicine and clinical guidelines. Several meta-analyticreviews of the behavioral literature have been pub-lished using varying study inclusion/exclusion criteria.The majority of the reviews have adopted the strategyof including data from all available treatment stud-ies regardless of experimental design (eg, single groupoutcome study vs controlled trial) or publication status(ie, published vs unpublished). However, the most re-cent meta-analyses have included only the most care-fully designed and reported trials and thus selectivelyincluded only trials that were randomized and con-trolled. Clearly, each of these analytic strategies hasits merits. The sections that follow describe the mostcomprehensive empirical reviews of both types, per-mitting comparison of the findings across different re-view methodologies. Meta-analyses are described forthe migraine, tension-type headache, minimal-contactformat, and pediatric literatures.

Migraine.—Goslin and colleagues62 with supportfrom the Agency for Healthcare Research and Qual-ity (AHRQ) published the most recent meta-analysis

S98 May 2005

of the behavioral literature which also has employedthe most conservative study inclusion criteria to date.The literature search identified 355 articles describingbehavioral and physical treatments for migraine, ofwhich 70 reported controlled clinical trials of behav-ioral treatments for migraine in adults. A total of 39prospective and randomized trials met all of the strin-gent research design and data extraction requirements;the 39 trials yielded 60 treatment groups of behavioraltreatments: relaxation training, temperature biofeed-back, temperature biofeedback plus relaxation, EMGbiofeedback, cognitive-behavioral therapy (stress-management training), cognitive-behavioral therapyplus temperature biofeedback, waitlist control, andother controls. Treatment outcome data were calcu-lated using two metrics: summary effect size esti-mates and mean percentage headache improvementfrom pre- to posttreatment. Behavioral interventionsyielded 32% to 49% reductions in migraine versus 5%reduction for no-treatment controls (Fig. 2). Resultsindicated that relaxation training, thermal biofeed-back combined with relaxation, EMG biofeedback,and cognitive-behavioral therapy were all statisticallymore effective than waitlist control.

Fig 2.—Meta-analyses of behavioral and pharmacological treatments for migraine: percentage improvement scores by treatmentcondition. RLX: relaxation training; BF: biofeedback; EMG: electromyographic; CBT: cognitive-behavioral treatment; Ceph. Vaso.BF: cephalic vasomotor biofeedback.

The AHRQ-sponsored meta-analysis62 is the onlyempirical review of the behavioral migraine literatureto date to employ highly selective study inclusion crite-ria. Earlier meta-analyses were maximally inclusive ofthe available research.63-66 Nevertheless, the findingsof the other meta-analyses closely parallel the AHRQreview indicating that behavioral treatments for mi-graine headache are effective (35% to 55% improve-ment), and all treatments are more effective than con-trol conditions (Fig. 2). There is a sizeable amount ofevidence indicating that, at least among those patientswho respond initially, the effects of behavioral treat-ments endure over time with the longest follow-up oc-curring 7 years posttreatment.66,67 For example, Blan-chard and colleagues68 found that 91% of migraineheadache sufferers remained significantly improved5 years after completing behavioral headache treat-ment.

The comparative efficacy of pharmacologic ver-sus behavioral therapies for migraine has only rarelybeen directly assessed.32,69-72 However, meta-analyticcomparisons have yielded similar levels of improve-ment in migraine with propranolol (among themost widely employed and most effective preventive

Headache S99

pharmacologic therapies for migraine; 32 trials), flu-narizine (a calcium channel blocker widely used formigraine prophylaxis in Canada and Europe; 31 trials),and combined relaxation and biofeedback training(35 trials).65,73,74 By comparison, patients receivingplacebo pills for migraine showed only a 12% improve-ment on average (Fig. 2). Thus, the best of the preven-tive pharmacologic and behavioral therapies appearto be similarly viable for uncomplicated migraine pa-tients.

Tension-Type Headache.—A meta-analysis of be-havioral treatments for tension-type headache wasrecently completed75 employing methodology thatclosely paralleled the Goslin et al62 review of the mi-graine literature. Like the Goslin and colleagues’ re-view, this analysis employed stringent research designand data extraction requirements and selectively in-cluded only randomized, controlled trials. McCroryand colleagues’75 literature search identified 107 arti-cles describing behavioral treatments for tension-typeheadache published between 1966 and 1999. The 35prospective and randomized trials that met all of thestringent research design and data extraction require-ments; the 35 trials yielded the following 77 treatmentgroups: relaxation training, EMG biofeedback, EMG

Fig 3.—Meta-analyses of behavioral and pharmacological treatments for tension-type headache: percentage improvement scores bytreatment condition. RLX: relaxation training; BF: biofeedback; EMG: electromyographic; CBT: cognitive-behavioral treatment.

biofeedback plus relaxation, cognitive-behavioraltherapy [stress-management training], waitlist con-trol, and other controls. For comparison purposes,controlled trials of amitriptyline, arguably the mostcommonly prescribed medication for prophylaxis oftension-type headache, were identified. Interestingly,only three such trials could be identified in the pub-lished literature. As in the Goslin et al62 review, treat-ment outcome data were calculated using two metrics:summary effect size estimates and average percentageimprovement from pre- to posttreatment. Behavioralinterventions for tension-type headache yielded 37%to 50% reduction in headache versus 2% reductionfor no treatment, and 9% for other controls (Fig. 3).The effect size estimates indicated that all of the be-havioral interventions statistically were more effectivethan waitlist control.

The meta-analysis by McCrory and colleagues75

is the only one to employ highly selective study in-clusion criteria for tension-type headache (similar toGoslin et al62 for migraine). All other meta-analysesof the tension-type literature have been maximally in-clusive of all available research.76-78 Just the same,these earlier meta-analyses have reported findings thatclosely parallel the McCrory and colleagues’75 review:

S100 May 2005

behavioral treatments for tension-type headache areefficacious (typically 35% to 55% headache reductionfrom pre- to posttreatment), and all treatment condi-tions statistically are more effective than control con-ditions (Fig. 3).

Even less evidence is available to address thecomparative efficacy of pharmacologic versus behav-ioral therapies for tension-type than for migraineheadache.79-82 Because relatively few trials of medica-tion prophylaxis for tension-type headache have beenpublished to date, even meta-analytic techniques can-not shed much light on this issue. The three controlledstudies of amitriptyline for tension-type headache re-viewed by McCrory et al75 have yielded, on aver-age, a 33% reduction in headache activity, which ison the low end of the range achieved by behav-ioral therapies (Fig. 3). Perhaps the best available evi-dence addressing this issue is provided by the studyof Holroyd et al,83 which randomly assigned over200 tension-type headache patients to one of fourconditions: (i) tricyclic antidepressant medication, (ii)stress-management training, (iii) combined antide-pressant and stress-management, or (iv) medicationplacebo. Medication and behavioral therapy each pro-duced larger reductions in headache activity, analgesicmedication use, and headache-related disability thanplacebo, but the medication condition yielded morerapid improvements in headache activity. The com-bined therapy was more likely to produce clinicallymeaningful reductions in headache (64% of patients)than either antidepressant medication (38%) or stress-management training (35%); whereas both treatmentstrategies are modestly effective, the combined ther-apy may improve outcomes.

As in the migraine literature, there is a sizeableamount of evidence indicating that, at least amongthose who respond initially, the effects of behavioraltreatments endure over time, with the longest follow-up occurring after 7 years.67 These effects endurewhether further contact is provided (booster sessions)or not.84 For example, Blanchard and colleagues68

found that 78% of tension-type sufferers and 91% ofmigraine sufferers remained significantly improved 5years following behavioral treatment. Likewise, a ret-rospective examination of nearly 400 headache pa-tients who completed a comprehensive treatment pro-

gram that included relaxation and biofeedback foundthat 65% reported maintaining their treatment gains.85

Though retrospective, these results are presented herebecause of the large sample size and the fact thatthe data were collected within a clinical program (vsthe more typical research program) and, as such, mayaddress in vivo the issue of “effectiveness” (vs “effi-cacy”).

Minimal-Contact Format.—The most comprehen-sive meta-analytic review of the minimal-contact(home-based) treatment literature was published byHaddock and colleagues.55 The reviewers identified20 prospective and randomized controlled trials pub-lished between 1977 and 1996, including five pediatricor adolescent studies. Studies of migraine (6 studies),tension-type (8 studies) and combined diagnosis (6studies) were included in the review. Similar to theclinic-based behavioral treatments described above,minimal-contact treatments included: cognitive ther-apy, relaxation training, and in some instances abbre-viated biofeedback components adapted for home use.Thirteen studies directly compared minimal-contact tostandard clinic-based treatment, while nine trials com-pared minimal-contact to waitlist or attention control.The 13 direct study comparisons averaged 2.7 clinicvisits (161.5 [SD = 79.9] minutes with therapist) forminimal-contact versus 8.6 (483.8 [SD = 164.6] min-utes with therapist) for clinic-based. Treatment out-come data were calculated using effect size scores.For studies comparing minimal-contact to waitlist orattention control, minimal-contact treatment condi-tions were statistically more effective than controlconditions. For studies comparing minimal-contact toclinic-based, minimal-contact was equivalent or su-perior to clinic-based treatment. The review also re-ported the percentage of patients clinically improved(ie, headache decreased ≥50%) for the 13 studiesproviding direct comparisons; for migraine, tension-type and combined diagnoses, respectively, minimal-contact (53.2%, 40.5%, 51.0%) was similar to clinic-based (52.5%, 41.5%, 42.9%) in the percentage ofpatients with a 50% or greater percentage headachechange from pre- to posttreatment. Findings of themeta-analysis by Haddock and colleagues55 were con-sistent with the earlier meta-analytic reviews of theminimal-contact treatment literature by Rowan and

Headache S101

Andrasik57 and by Rains, Penzien, and Holroyd56

(Figs. 2 and 3).In a cost-conscious healthcare environment, cost

effectiveness often is more important than overalleffectiveness for widespread implementation of anygiven intervention. Haddock and colleagues55 also em-ployed meta-analytic techniques to evaluate the rela-tive cost effectiveness of minimal-contact therapy rel-ative to “standard” clinic-based behavioral therapy.Cost-effectiveness was calculated using the formula:[% improvement/clinician contact time]. The sevenstudies for which cost-effectiveness scores could be cal-culated demonstrated minimal contact to be five-foldmore cost effective than clinic-based behavioral ther-apy. A more recent study86 similarly revealed minimal-contact behavioral interventions to be the least ex-pensive treatment option after 1 year, not only rel-ative to clinic-based behavioral treatment, but alsorelative to even low-priced prophylactic headachemedications.

Pediatric Migraine.—The pediatric headache liter-ature includes fewer studies than the adult literature.Hermann and colleagues87 identified a total of 38 be-havioral and 34 pharmacological studies evaluatingtreatment of pediatric migraine published between1970 and 1993; only 17 behavioral studies (31 sepa-rate treatment groups) and 24 drug studies (50 sepa-rate treatment groups) met inclusion criteria for meta-analysis. Behavioral treatments included: progressiverelaxation training, autogenic training, autogenic plusprogressive relaxation training, thermal biofeedback,thermal biofeedback plus progressive relaxation train-ing, cognitive-behavioral treatment, cognitive ther-apy, waitlist control, and other controls. Pharma-cologic treatments included: propranolol, calcium-channel blockers, serotonergic drugs, dopaminergicdrugs, ergotamine, clonidine, and placebo. Althoughthe authors acknowledged that the small number ofstudies in this literature substantially limited the con-clusions that could be drawn, they concluded thatthere was sufficient evidence to indicate that thermalbiofeedback and interventions combining biofeed-back and progressive relaxation training were supe-rior to other behavioral treatments, the more com-monly used prophylactic drug treatments and placebo.Hermann and colleagues87 also concluded that there

was some indication of effectiveness of propranolol fortreatment of pediatric migraine, but the small numberof studies precluded a more definitive conclusion.

A more recent review examined the effective-ness of behavioral treatment in pediatric versusadult headache sufferers (migraine and tension-typeheadache).88 This meta-analysis of the biofeedbacktraining literature demonstrated a marked headacheimprovement following thermal and EMG biofeed-back among children (aged 7 to 19 years). The responseamong children was greater than the response ob-served among adults. Headache improvement acrosspediatric studies averaged 62% and 81% for thermaland EMG biofeedback, respectively, versus 34% and48% for adults.

METHODOLOGICAL CRITIQUEIn evaluating the clinical applicability and

methodological quality of the trial literature on be-havioral therapies for headache, it is natural to drawcomparisons with the much larger body of research onpharmacologic treatments for headache. The two bod-ies of research differ in many respects, yet share somecommon problems.

The main issues to be discussed in relation tobehavioral trials concern the recruitment and selec-tion of subjects; sample size and statistical power; theuse of a credible control; and the reproducibility ofthe interventions studied. Some of the problems de-scribed below are specific to trials of behavioral inter-ventions (eg, difficulty of blinding), while others alsopertain to drug treatment trials (eg, defining clinicallysignificant improvement); still others might be de-scribed as “cultural” problems (eg, the lack of integra-tion of behavioral and medical populations). Table 2lists methodologic considerations addressed in this cri-tique and provides citations to articles further address-ing these issues within a special series of papers ad-dressing headache research methodology published inHeadache as a companion to this supplement.

Recruitment of Subjects.—One important concernin interpreting the behavioral therapy trial literature isthat there may be some bias in the selection of subjects.Subjects for studies of behavioral therapies are oftenrecruited from nonmedical populations using meanssuch as newspaper or other media advertisements.

S102 May 2005

Table 2.—Methodological Consideration in BehavioralHeadache Trials

SampleRepresentativeness of the sample (nonclinical

populations, specialty headache, and chronic painclinics)96

Generalizability to majority populations (especiallyaverage headache patients in primary care)113

Classification by headache diagnosis to conform tostandard prevailing diagnostic nosology110

DesignSample size and statistical power (power analysis)106

Statistically versus clinically significant change96

Trial designs employing small samples107,109,111

Control groups19,111

Blinding or masking [and controlling bias when blindingis not possible or feasible]19

Outcome measures and headache-related variables ofinterest12,108,114,115

TreatmentTreatment integrity113

Generalizability (transportability and availability) toclinical practice115

Comparability with medical standard of care112

Interactions with pharmacologic treatments forheadache prevention112

This was the case, for example, in nearly half of thestudies reviewed by Goslin and colleagues.62 Dataon headache sufferers who may not have soughtmedical care are important, since studies have shownthat a substantial proportion of people with migraineremain undiagnosed or do not seek care from a physi-cian.89,90 However, the recruitment of patients fromnonmedical populations is one factor that limits com-parison between behavioral and drug trials. Further-more, some behavioral trials use quite narrow popula-tions, such as undergraduate university students, as arecruiting pool, which further limits the generalizabil-ity of their findings to clinical populations.

Any bias in the populations studied (eg, an aver-sion to drug therapy, a preference for psychologicaltherapy, associated anxiety or other comorbid condi-tions) could limit the generalizability of data from be-havioral trials to other populations. There are, how-ever, few empirical data to support the notion thatsubstantial biases of this sort exist.

Selection of Subjects.—Diagnostic Specificity.—Subjects in behavioral treatment trials are often notcharacterized using clinical diagnoses that are as spe-

cific as would be desirable, although this has improvedin recent years. The lack of sufficient specificity inheadache diagnosis is, in part, a result of changesover the years in the formal criteria used to diagnoseheadache. These criteria have developed and changeda great deal from the Ad Hoc criteria of 196291 to thefirst92 and second93 editions of the International Clas-sification of Headache Disorders (ICHD). In general,the trend has been to move from a few broad categoriesthat were rather vaguely defined to a large number ofmore specific diagnoses with precise criteria.

In addition to these changes in the diagnosticcriteria, however, there was also a tradition in theearly behavioral headache literature of regarding spe-cific headache diagnoses as relatively unimportant, be-cause the conceptual model guiding such therapiessuggested that their effects were independent of anyspecific headache disorder. Patients were often re-cruited on the basis of frequent headache symptomsalone, regardless of their particular headache diagno-sis. Indeed, subjects were often recruited from a non-medical setting, and sometimes did not have an exist-ing medical diagnosis or did not receive one as part oftheir involvement in the study.

Part of the problem has been that the existingformal diagnostic criteria have not dealt very effec-tively with patients of the type often included in be-havioral treatment trials, namely, patients with veryfrequent headaches with migrainous features, or whichseemed to evolve from episodic migraine. Such pa-tients have been classified in the most recent versionof the ICHD.93

Sample Size and Power.—In general, trials of be-havioral therapies for headache are relatively small.Although they may have sufficient power to demon-strate a statistically significant difference, they rarelyspecify a minimal clinically important difference forthe main outcome measure on which power calcula-tions might be based. Thus, even when statistically sig-nificant differences are found, the clinical importanceof these findings often remains uncertain. For exam-ple, the most commonly reported outcome measuresin behavioral trials have been headache frequencyand headache index, most often analyzed as contin-uous variables. Occasionally, data on these outcomeshave been used to calculate the proportion of patients

Headache S103

experiencing a 50% or greater reduction in headachefrequency or headache index.84,94,95 These generallyare recognized as clinically relevant outcomes.96 Un-fortunately, dichotomous outcomes of this sort areless efficient in that they require larger sample sizeto demonstrate a statistically significant result. Similarproblems result when different components of behav-ioral treatment are assessed to test whether combinedbehavioral approaches are better than single modes.Small studies, which often fail to find statistically signif-icant differences between combined and single modal-ities, sometimes lead to the conclusion that there isno difference between them, when in fact small sam-ple sizes and low statistical power may mask clinicallyimportant differences. Acknowledging these problemsrelating to small sample sizes, researchers in many tri-als have made study design modifications to improvestatistical power, given limited sample sizes. For exam-ple, many behavioral studies use within-sample match-ing techniques when assigning subjects to treatmentgroups (to ensure equivalence of groups on importantindependent variables).97-99 This serves to reduce vari-ance and increase statistical power.

Use of a Credible Control.—Treatment efficacy re-search involves demonstrating a statistically and clin-ically significant benefit of treatment while control-ling patient and experimenter bias as well as nonspe-cific treatment effects. Usually, such research involvescomparison of active treatment(s) with a credible ac-tive control condition, ideally with blinding. By farthe most common control used in behavioral treat-ments trials is an inactive waitlist condition. The lesscommon “placebo,” or active control, conditions in-clude a variety of experimental conditions designedto improve the validity of the comparison by single-blinding or double-blinding, or by providing a credi-ble alternative therapy with no therapeutic value. Ex-amples from the behavioral headache literature haveincluded pseudomeditation,100 a placebo pill (subjectswere misled that it was an effective muscle relaxant),101

or sham biofeedback (altered contingency or noncon-tingent EMG biofeedback).102 The magnitude of theeffect of such placebo or active control conditions issmall, having an effect size estimated at 0.15, whichwas not statistically different from the waitlist controlin two meta-analyses.62,75 That is, the “placebo” effect

was not large enough to rival the treatment effects ofbehavioral therapies in the same sets of studies.

Double-blinding is impossible for most behavioralinterventions, and effective single-blinding is also dif-ficult to achieve in most cases.19 The use of waitlistcontrols (rather than credible placebos) and the lackof blinding make behavioral trials more prone to biasthan traditionally designed drug trials, and more likelyto find a spurious statistically significant result.

Reproducibility of the Intervention.—Behavioraltherapies, as described above, are fairly complex in-terventions. Issues such as therapist training, integrityof treatment, and compliance all serve to complicatethe reproducibility and transportability of a behavioralintervention. A few trials have empirically studied dif-ferent methods of delivering behavioral therapies, test-ing the importance of home practice,94,103 intensity oftherapist contact,104 and booster training.84 However,many aspects of the delivery of therapy remain inade-quately studied, and variations in these therapies dueto personnel, setting, and other factors may partiallydetermine whether the intervention will work as wellin practice as in trials.

CONCLUSIONSSince its genesis in the mid-20th century, behav-

ioral headache research has grown, matured scientif-ically, and despite methodological imperfections hasyielded impact on contemporary headache manage-ment. The past three decades have amassed a consid-erable evidence base addressing behavioral headachetreatments. This literature exhibited unprecedentedgrowth in the 1970s and early 1980s stimulatedby the development of biofeedback treatments forheadache. Although the number of psychophysiologyand biofeedback studies has declined in recent years,behavioral headache research productivity has contin-ued to grow in both number and breadth of studies.Publication trends show greater proportions of con-trolled than uncontrolled trials, and assessment of abroadening range behavioral and functional variablespertinent to average headache sufferer.

Meta-analytic literature reviews of behavioral in-terventions (relaxation training, biofeedback, cog-nitive-behavioral therapy) have consistently shownbehavioral therapies to be effective treatments for

S104 May 2005

primary headache. Across studies, behavioral inter-ventions have yielded approximately a 35% to 55% re-duction in migraine and tension-type headache param-eters. Although direct comparisons of behavioral andpharmacologic treatments for headache are few, theavailable evidence suggests that the level of headacheimprovement with behavioral interventions may rivalthose obtained with widely used pharmacologic ther-apies in representative patient samples.

Clinical trials research is evolving with compar-isons to standard pharmacologic treatments, broaderpopulations (eg, pediatric, elderly), and cost-effectiveapplications (minimal-contact or home-based for-mats). It should be noted, there are preliminarystudies of additional, novel applications that werenot addressed in this overview because of the lim-ited evidence but are discussed elsewhere2,105 (eg,Internet-facilitated interventions, self-managementtraining programs designed for physician practicesettings).

Although research has yielded solid empiricalfoundations for behavioral headache treatments, thisliterature is not without methodologic limitations.Certain methodologic criticisms presented here ap-ply uniquely or disproportionately to behavioral tri-als, while others might apply as well to pharmacologicheadache trials. Most behavioral treatments, by virtueof the inherent therapeutic relationship and psycho-logical change process, cannot be blinded, crossed overor placebo controlled; thus, there are unique researchdesign challenges in controlling bias.19 As referencedin Table 2, many of the methodologic considerationsaddressing recruitment, design, and treatment in be-havioral research have been addressed in the guide-line for behavioral trials published in this supplementand expounded in the related series of papers pub-lished in the companion issue of the journal.12,19,106-114

Nevertheless, assessment of the sum of the literaturehas yielded endorsements for behavioral headachetreatments by numerous professional organizations(Table 1).

Despite substantial growth, endorsement, and in-creasing integration of behavioral headache treat-ments into headache management, there remain sub-stantial opportunities to strengthen and expand boththe research base and clinical application of these ther-

apies. Future directions are discussed in detail else-where115 and Guidelines for Trials of Behavioral Treat-ments for Recurrent Headache96 were published tofacilitate production of high-quality research. Likely,current treatments represent only a fraction of what ispossible in the application of behavioral and psycho-logical principals to headache.

REFERENCES

1. Penzien DB, Rains JC, McGrath PJ. Psychologicaland behavioral treatments of migraine. In: OlesenJ, Goadsby P, Ramadan N, Tfelt-Hansen P, WelchKMA, eds. The Headaches, 3rd ed. Philadelphia,PA: Lippincott, Williams, & Wilkins; in press.

2. Penzien DB, Rains JC, Andrasik F. Behavioralmanagement of recurrent headache: three decadesof experience and empiricism. Appl PsychophysiolBiofeedback. 2002;27:163-181.

3. Wolff HG. Life stress and bodily disease: a for-mulation. Res Publ Assoc Res Nerv Ment Dis.1949;29:1059-1094.

4. Wolff HG. Stress and Disease. Springfield, IL:Charles C. Thomas; 1953.

5. Simmons LW, Wolff HG. Social Science in Medicine.New York: Russell Sage Foundation; 1954.

6. Friedman AP, Brenner C. Psychological mecha-nisms in chronic headache. Res Publ Assoc Res NervMent Dis. 1949;29:605-608.

7. Cannon WB. Bodily Changes in Pain, Hunger, Fear,and Rage: An Account of Recent Researches Intothe Function of Emotional Excitement. New York:Appleton; 1915.

8. Cannon WB. Stresses and strains of homeostasis(Mary Scott Newbold Lecture). Am J Med Sci.1935;189:1-14.

9. Selye H. A syndrome produced by diverse nocu-ous agents. Nature. 1936;138:32. [Reprinted in: Ney-lan J. Hans Selye and the Field of Stress ResearchJ Neuropsychiatry Clin Neurosci. 1998;10(2):230-231].

10. Selye H, Fortier C. Adaptive reactions to stress.Res Publ Assoc Res Nerv Ment Dis. 1949;29:3-18.

11. Selye H. The Physiology and Pathology of Exposureto Stress. A Treatise Based on the Concepts of theGeneral-Adaptation-Syndrome and the Diseases ofAdaptation. Montreal: Acta Inc. Medical Publish-ing; 1950.

Headache S105

12. Lake AE III, Rains JC, Penzien DB, Lipchik GL.Headache and psychiatric comorbidity: historicalcontext, clinical implications, and research rele-vance. Headache. 2005;45:493-506.

13. Engel GL. The need for a new medical model: a chal-lenge for biomedicine. Science. 1977;196:129-136.

14. Weiner H. Praise be to psychosomatic medicine.Psychosom Med. 1999;61:259-262.

15. Schwartz GE, Weiss SM. Behavioral medicine re-visited: an amended definition. J Behav Med.1978;1:249-251.

16. Shapiro D, Schwartz GE. Biofeedback and vis-ceral learning: clinical applications. Semin Psychi-atry. 1972;4:171-184.

17. Keefe FJ, Lumley MA, Buffington AL, et al. Chang-ing face of pain: evolution of pain research in psy-chosomatic medicine. Psychosom Med. 2002;64:921-938.

18. Simons DW, Wolff HG. Studies on headache: mech-anisms of chronic and post-traumatic headache. Psy-chosom Med. 1946;8:227-242.

19. Rains JC, Penzien DB. Behavioral research andthe double-blind placebo-controlled methodol-ogy: challenges in applying the biomedical stan-dard to behavioral headache research. Headache.2005;45:479-486.

20. Budzynski TH, Stoyva JM. An instrument for pro-ducing deep muscle relaxation by means of ana-log information feedback. J Appl Behav Anal.1969;2:231-237.

21. Budzynski TH, Stoyva JM, Adler C. Feedback-induced muscle relaxation: applications to tensionheadache. J Behav Ther Exp Psychiat. 1970;1:205.

22. Budzynski TH, Stoyva JM, Adler CS, MullaneyDJ. EMG biofeedback and tension headache:a controlled outcome study. Psychosom Med.1973;35:484-496.

23. Sargent JD, Green EE, Walters ED. The use of au-togenic feedback training in a pilot study of migraineand tension headaches. Headache. 1972;12:120-124.

24. Blanchard EB, Theobald DE, Williamson DA, Sil-ver BV, Brown DA. Temperature biofeedback inthe treatment of migraine headaches: a controlledevaluation. Arch Gen Psychiatry. 1978;35:581-588.

25. Diamond S, Medina J, Diamond-Falk J, DeVeno T.The value of biofeedback in the treatment of chronicheadache: a five-year retrospective study. Headache.1979;19:90-96.

26. Duckro PN, Tait R, Margolis RB, Silvermintz S. Be-havioral treatment of headache following occupa-tional trauma. Headache. 1985;25:328-331.

27. Gauthier J, Bois R, Allaire D, Drolet M. Evaluationof skin temperature biofeedback training at two dif-ferent sites for migraine. J Behav Med. 1981;4:407-419.

28. Holroyd KA, Andrasik F. Coping and the self-control of chronic tension headache. J Consult ClinPsychol. 1978;46:1036-1045.

29. Holroyd KA, Penzien DB, Hursey KG, et al. Changemechanisms in EMG biofeedback training: cogni-tive changes underlying improvements in tensionheadache. J Consult Clin Psychol. 1984;52:1039-1053.

30. Jurish SE, Blanchard EB, Andrasik F, Teders SJ,Neff DF, Arena JG. Home- versus clinic-basedtreatment of vascular headache. J Consult Clin Psy-chol. 1983;51:743-751.

31. Lake A, Rainey J, Papsdorf JD. Biofeedback andrational-emotive therapy in the management of mi-graine headache. J Appl Behav Anal. 1979;12:127-140.

32. Mathew NT. Prophylaxis of migraine and mixedheadache. A randomized controlled study. Head-ache. 1981;21:105-109.

33. Mitchell KR, White RG. Control of migraineheadache by behavioral self-management: a con-trolled case study. Headache. 1976;16:178-184.

34. Saper JR. Migraine. II. Treatment. JAMA.1978;239:2480-2484.

35. Sovak M, Kunzel M, Sternbach RA, Dalessio DJ.Is volitional manipulation of hemodynamics a validrationale for biofeedback therapy of migraine?Headache. 1978;18:197-202.

36. Weeks R, Baskin S, Sheftell F, Rapoport A, Ar-rowsmith F. A comparison of MMPI personalitydata and frontalis electromyographic readings intwo groups of daily headache sufferers. Headache.1983;23:83-85.

37. Jacobson E. Progressive Relaxation: A Physiologi-cal and Clinical Investigation of Muscular States andTheir Significance in Psychology and Medical Prac-tice. Chicago: University of Chicago Press; 1929.

38. Jacobson E. Progressive Relaxation. Chicago: Uni-versity of Chicago Press; 1934.

39. Bernstein DA, Borkovec TD. Progressive Relax-ation Training: A Manual for the Helping Profes-sions. Champaign, IL: Research Press; 1973.

S106 May 2005

40. Bernstein DA, Borkovec TD, Hazlett-Stevens H.New Directions in Progressive Relaxation Training:A Guidebook for Helping Professionals. Westport,CT: Praeger Publishers; 2000.

41. Schultz J, Luthe W. Autogenic Training: A Psy-chophysiologic Approach to Psychotherapy, Vol. 1.New York: Grune & Stratton; 1959.

42. Benson H. The Relaxation Response. New York:William Morrow & Co; 1975.

43. Benson H, Klemchuk HP, Graham JR. The useful-ness of the relaxation response in the therapy ofHeadache. Headache. 1974;14:49-52.

44. Zitman FG, van Dyck R, Spinhoven P, Linssen AC.Hypnosis and autogenic training in the treatment oftension headaches: a two-phase constructive designstudy with follow-up. J Psychosom Res. 1992;36:219-228.

45. ter Kuile MM, Spinhoven P, Linssen AC. Respon-ders and nonresponders to autogenic training andcognitive self-hypnosis: prediction of short- andlong-term success in tension-type headache patients.Headache. 1995;35:630-636.

46. ter Kuile MM, Spinhoven P, Linssen AC, ZitmanFG, van Dyck R, Rooijmans HG. Autogenic trainingand cognitive self-hypnosis for the treatment of re-current headaches in three different subject groups.Pain. 1994;58:331-340.

47. Spiegel D, Moore R. Imagery and hypnosis in thetreatment of cancer patients. Oncology (Huntingt).1997;11:1179-1195.

48. Ludwig AM. An historical survey of the early rootsof mesmerism. Int J Clin Exp Hypn. 1964;12:205-217.

49. Beck AT. Cognitive Therapy and the Emotional Dis-orders. New York: International Universities Press;1979.

50. Ellis A. Reason and Emotion in Psychotherapy. NewYork: Lyle Stuart; 1962.

51. Meichenbaum DH. Stress Inoculation Training. St.Louis, MO: Elsevier Science & Technology Books;1985.

52. Holroyd KA, Andrasik F. A cognitive-behavioralapproach to recurrent tension and migraineheadache. In: Kendall PE, ed. Advances inCognitive-Behavioral Research and Therapy. NewYork: Academic Press; 1982.

53. Holroyd KA, Holm JE, Penzien DB. Clinical issuesin the behavioral treatment of recurrent headache.In: Keller PA, Heyman SR, eds. Innovations in Clin-

ical Practice: A Source Book, Vol. 7. Sarasota, FL:Professional Resource Exchange; 1988:433-457.

54. Blanchard EB, Andrasik F. Management of ChronicHeadaches: A Psychological Approach. New York,NY: Pergamon Press; 1985.

55. Haddock CK, Rowan AB, Andrasik F, Wilson PG,Talcott GW, Stein RJ. Home-based behavioral treat-ments for chronic benign headache: a meta-analysisof controlled trials. Cephalalgia. 1997;17:113-118.

56. Rains JC, Penzien DB, Holroyd JE. Meta-analysisof alternative behavioral treatments for recurrentheadache. Headache. 1993;33:279-280.

57. Rowan AB, Andrasik F. Efficacy and cost-effectiveness of minimal therapist contact treat-ments for chronic headache: a review. Behav Ther.1996;27:207-234.

58. Board of Directors AASH. Biofeedback therapy.Headache. 1978;18:107.

59. McCrory DC, Matchar DB, Gray RN, RosenbergJH, Silberstein SD. Evidence-based guidelines formigraine headache: overview of program descrip-tion and methodology. November 1999. Prepared forthe US Headache Consortium. Available at: http://www.aan.com/professionals/practice/pdfs/gl0086.pdf; see “Headache – Tools.” Accessed February 9,2005.

60. Silberstein SD. Practice parameter: evidence-basedguidelines for migraine headache (an evidence-based review): report of the Quality Standards Sub-committee of the American Academy of Neurology.Neurology. 2000;55:754-762.

61. Campbell JK, Penzien DB, Wall EM. Evidence-based guidelines for migraine headache: behav-ioral and physical treatments. November 1999.Prepared for the US Headache Consortium.Available at: http://www.aan.com/professionals/practice/pdfsgl0089.pdf; see “Headache – Tools.”Accessed February 9, 2005.

62. Goslin RE, Gray RN, McCrory DC, PenzienD, Rains J, Hasselblad V. Behavioral and phys-ical treatments for migraine headache. Tech-nical review 2.2. February 1999. Prepared forthe Agency for Health Care Policy and Re-search under Contract No. 290-94-2025. Availableat: http://www.clinpol.mc.duke.edu (follow link to“Publications”). Accessed February 9, 2005.

63. Blanchard EB, Andrasik F, Ahles TA, Teders SJ,O’Keefe D. Migraine and tension-type headache: ameta-analytic review. Behav Ther. 1980;11:613-631.

Headache S107

64. Blanchard EB, Andrasik F. Psychological assess-ment and treatment of headache: recent develop-ments and emerging issues. J Consult Clin Psychol.1982;50:859-879.

65. Holroyd KA, Penzien DB. Pharmacological vs. non-pharmacological prophylaxis of recurrent migraineheadache: a meta-analytic review of clinical trials.Pain. 1990;42:1-13.

66. Penzien DB, Holroyd KA, Holm JE, HurseyKG. Behavioral management of migraine: resultsfrom five-dozen group outcome studies. Headache.1985;25:162.

67. Blanchard EB. Psychological treatment of be-nign headache disorders. J Consult Clin Psychol.1992;60:537-551.

68. Blanchard EB, Appelbaum KA, Guarnieri P,Morrill B, Dentinger MP. Five year prospectivefollow-up on the treatment of chronic headachewith biofeedback and/or relaxation. Headache.1987;27:580-583.

69. Holroyd KA, Holm JE, Hursey KG, et al. Recurrentvascular headache: home-based behavioral treat-ment vs. abortive pharmacological treatment. J Con-sult Clin Psychol. 1988;56:218-223.

70. Penzien DB, Johnson CA, Carpenter DE, Hol-royd KA. Drug vs. behavioral treatment of mi-graine: long-acting propranolol vs. home-based self-management training. Headache. 1990;30:300.

71. Sartory G, Muller B, Metsch J, Pothmann R. Acomparison of psychological and pharmacologicaltreatment of pediatric migraine. Behav Res Ther.1998;36:1155-1170.

72. Sovak M, Kunzel M, Sternbach RA, Dalessio DJ.Mechanism of the biofeedback therapy of migraine:volitional manipulation of the psychophysiologicalbackground. Headache. 1981;21:89-92.

73. Davis MK, Holroyd KA, Penzien DB. Flunar-izine and propranolol: comparative effectiveness inthe treatment of migraine headaches. Headache.1999;39:349.

74. Holroyd KA, Penzien DB, Cordingley GA. Pro-pranolol in the prevention of recurrent migraine: ameta-analytic review. Headache. 1991;31:333-340.

75. McCrory DC, Penzien DB, Hasselblad V, GrayRN. Evidence Report: Behavioral and PhysicalTreatments for Tension-Type and CervicogenicHeadache. Des Moines, IA: Foundation for Chiro-practic Education and Research; 2001. Product No.:2085.

76. Blanchard EB, Andrasik F, Ahles TA, Teders SJ,O’Keefe D. Migraine and tension-type headache: ameta-analytic review. Behav Ther. 1980;11:613-631.

77. Bogaards MC, ter Kuile MM. Treatment of recur-rent tension headache: a meta-analytic review. ClinJ Pain. 1994;10:174-190.

78. Holroyd KA, Penzien DB. Client variables and thebehavioral treatment of recurrent tension headache:a meta-analytic review. J Behav Med. 1986;9:515-536.

79. Bruhn P, Olesen J, Melgaard B. Controlled trialof EMG feedback in muscle contraction headache.Ann Neurol. 1979;6:34-36.

80. Holroyd KA, O’Donnell FJ, Stensland M, LipchikGL, Cordingley GE, Carlson BW. Managementof chronic tension-type headache with tricyclic an-tidepressant medication, stress management ther-apy, and their combination: a randomized controlledtrial. JAMA. 2001;285:2208-2215.

81. Holroyd KA, Nash JM, Pingel JD, CordingleyGE, Jerome A. A comparison of pharmacologi-cal (amitriptyline HCL) and nonpharmacological(cognitive-behavioral) therapies for chronic tensionheadaches. J Consult Clin Psychol. 1991;59:387-393.

82. Reich BA, Gottesman B. Biofeedback andpsychotherapy in the treatment of musclecontraction/tension-type headache. In: TollisonCD, Kunkel RS, eds. Headache: Diagnosis andTreatment. Baltimore: Williams and Wilkins;1993:167-183.

83. Holroyd KA, O’Donnell FJ, Stensland M, LipchikGL, Cordingley GE, Carlson BW. Managementof chronic tension-type headache with tricyclic an-tidepressant medication, stress management ther-apy, and their combination: a randomized controlledtrial. JAMA. 2001;285:2208-2215.

84. Andrasik F, Blanchard EB, Neff DF, RodichokLD. Biofeedback and relaxation training for chronicheadache: a controlled comparison of boostertreatments and regular contacts for long-termmaintenance. J Consult Clin Psychol. 1984;52:609-615.

85. Diamond S, Montrose D. The value of biofeedbackin the treatment of chronic headache: a four-yearretrospective study. Headache. 1984;24:5-18.

86. Mulkana SS, Penzien DB, Houle TT, Rains JC,Freidenberg BM. Expense of preventative drug andbehavioral headache therapies: an expanded analy-sis (abstract). Headache. 2004;44:515.

S108 May 2005

87. Hermann C, Kim M, Blanchard EB. Behavioraland pharmacological intervention studies of pedi-atric migraine: an exploratory meta-analysis. Pain.1995;60:239-256.

88. Sarafino EP, Goehring BA. Age comparisons inacquiring biofeedback control and success in reduc-ing headache pain. Ann Behav Med. 2000;22:10-16.

89. Lipton RB, Stewart WF, Simon D. Medical consul-tation for migraine: results from the American Mi-graine Study. Headache. 1998;38:87-96.

90. Lipton RB, Diamond S, Reed M, Diamond ML,Stewart WF. Migraine diagnosis and treatment:results from the American Migraine Study II.Headache. 2001;41:638-645.

91. Ad Hoc Committee on the Classification ofHeadache of the National Institute of NeurologicalDiseases and Blindness. Classification of headache.JAMA. 1962;179:717-718.

92. Headache Classification Committee of the Interna-tional Headache Society. Classification and diagnos-tic criteria for headache disorders, cranial neuralgiasand facial pain. Cephalalgia. 1988;8(suppl 7):1-96.

93. Headache Classification Subcommittee of the Inter-national Headache Society. The international classi-fication of headache disorders: 2nd edition. Cepha-lalgia. 2004;24(suppl 1):1-160.

94. Blanchard EB, Nicholson NL, Radnitz CL, SteffekBD, Appelbaum KA, Dentinger MP. The role ofhome practice in thermal biofeedback. J ConsultClin Psychol. 1991;59:507-512.

95. Blanchard EB, Appelbaum KA, Guarnieri P, et al.Two studies of the long-term follow-up of minimaltherapist contact treatments of vascular and ten-sion headache. J Consult Clin Psychol. 1988;56:427-432.

96. Penzien DB, Andrasik F, Freidenberg BM, et al.Guidelines for trials of behavioral treatments for re-current headache. Headache. 2005;45(suppl 2):S110-S132.

97. Holroyd KA, Nash JM, Pingel JD. A compari-son of pharmacological (amitriptyline HCL) andnonpharmacological (cognitive-behavioral) thera-pies for chronic tension headaches. J Consult ClinPsychol. 1991;59:387-393.

98. Mosley TH, Grothues CA, Meeks WM. Treatmentof tension headache in the elderly: a controlled eval-uation of relaxation training and relaxation trainingcombined with cognitive-behavior therapy. J ClinGeropsychol. 1995;1:175-188.

99. Rokicki LA, Holroyd KA, France CR, Lipchik GL,France JL, Kvaal SA. Change mechanisms associ-ated with combined relaxation/EMG biofeedbacktraining for chronic tension headache. Appl Psy-chophysiol Biofeedback. 1997;22:21-41.

100. Blanchard EB, Appelbaum KA, Radnitz CL, et al.Placebo-controlled evaluation of abbreviated pro-gressive muscle relaxation and of relaxation com-bined with cognitive therapy in the treatment of ten-sion headache. J Consult Clin Psychol. 1990;58:210-215.

101. Cox DJ, Freundlich A, Meyer RG. Differentialeffectiveness of electromyograph feedback, ver-bal relaxation instructions, and medication placebowith tension headaches. J Consult Clin Psychol.1975;43:892-898.

102. Paiva T, Nunes JS, Moreira A, Santos J, Teixeira J,Barbosa A. Effects of frontalis EMG biofeedbackand diazepam in the treatment of tension headache.Headache. 1982;22:216-220.

103. Gauthier J, Cote G, French D. The role of homepractice in the thermal biofeedback treatmentof migraine headache. J Consult Clin Psychol.1994;62:180-184.

104. Richardson GM, McGrath PJ. Cognitive-behavioraltherapy for migraine headaches: a minimal-therapist-contact approach versus a clinic-based ap-proach. Headache. 1989;29:352-357.

105. Penzien DB, Rains JC, Lipchik GL, Creer TL. Be-havioral interventions for tension-type headache:overview of current therapies and recommenda-tion for a self-management model for chronicheadache. Curr Pain Headache Rep. 2004;8:489-499.

106. Houle TT, Penzien DB, Houle CK. Statistical powerand sample size estimation for headache research: anoverview and power calculation tools. Headache. inpress.

107. Lipchik GL, Nicholson RA, Penzien DB. Allocationof patients to conditions in headache clinical trials:randomization, stratification, and treatment match-ing. Headache. 2005;45:419-428.

108. Andrasik F, Lipchik GL, McCrory DC, WittrockDA. Outcome measurement in headache research:headache parameters and psychosocial outcomes.Headache. 2005;45:429-437.

109. Houle TT, Remble TA, Houle TA. The examina-tion of headache activity using time series researchdesigns. Headache. 2005;45:438-444.

Headache S109

110. McCrory DC, Gray RN, Tfelt-Hansen P, Steiner TJ,Taylor FR. Methodological issues in systematic re-views of headache trials: adapting historical diagnos-tic classifications and outcome measures to presentday standards. Headache. 2005;45:459-465.

111. Hursey KG, Rains JC, Penzien DB, Nash JM,Nicholson RA. Behavioral headache research:methodologic considerations and research design al-ternatives. Headache. 2005;45:466-478.

112. Holroyd KA, Powers SW, Andrasik F. Methodolog-ical issues in clinical trials of drug and behavior ther-apies. Headache. 2005;45:487-492.

113. Nash JM, McCrory D, Nicholson RA, Andrasik F.Efficacy and effectiveness approaches in behavioraltreatment trials. Headache. 2005;45:507-512.

114. Nicholson RA, Hursey KG, Nash JM. Modera-tors and mediators of behavioral intervention forheadache. Headache. 2005;45:513-519.

115. Penzien DB, Rains JC, Lipchik GL, Nicholson RA,Lake AE, Hursey KG. Future directions in behav-ioral headache research: applications for an evolv-ing healthcare environment. Headache. 2005;45:526-534.

116. Health and Public Policy Committee, American Col-lege of Physicians. Biofeedback for headaches. AnnIntern Med. 1985;102:128-131.

117. Diagnostic and therapeutic technology assessment.

Biofeedback. JAMA. 1983;250:2381.118. Association for Advancement of Behavior Ther-

apy. Fact Sheet on Headache. 1988. Available at:http://www.aabt.org/publication/.

119. Association for Applied Psychophysiology andBiofeedback. Biofeedback and psychophysiol-ogy: efficacy. 2005. Available at: http://www.aapb.org/i4a/pages/index.cfm?pageid=3336.

120. Pryse-Phillips WE, Dodick DW, Edmeads JG, et al.Guidelines for the diagnosis and management of mi-graine in clinical practice. Canadian Headache So-ciety. CMAJ. 1997;156:1273-1287.

121. Pryse-Phillips WE, Dodick DW, Edmeads JG, et al.Guidelines for the nonpharmacologic managementof migraine in clinical practice. Canadian HeadacheSociety. CMAJ. 1998;159:47-54.

122. Integration of behavioral and relaxation approachesinto the treatment of chronic pain and insom-nia. NIH Technol Assess Statement. 1995;16-18:1-34.

123. NIH Technology Assessment Panel. Integrationof behavioral and relaxation approaches into thetreatment of chronic pain and insomnia. JAMA.1996;276:313-318.

124. Holroyd KA, Penzien DB. Self-Management ofRecurrent Headache. Geneva, Switzerland: WorldHealth Organization; 1993.