Guidelines for trials of behavioral treatments for recurrent headache: purpose, process, and product.
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Behavior Therapy↗
Biomedical subjects
Donald B Penzien
Publications and source records attributed to Donald B Penzien.
Behavioral headache treatment: history, review of the empirical literature, and methodological critique.
Theoretical developments and burgeoning research on stress and illness in the mid-20th century yielded the foundations necessary to conceptualize headache as a psychophysiological disorder and eventually to develop and apply contemporary behavioral headache treatments. Over the past three decades, these behavioral headache treatments (relaxation training, biofeedback, cognitive-behavioral therapy, and stress-management training) have amassed a sizeable evidence base. Meta-analytic reviews of the literature consistently have shown behavioral interventions to yield 35% to 55% improvements in migraine and tension-type headache and that these outcomes are significantly superior to control conditions. The strength of the evidence has lead many professional practice organizations to recommend use of behavioral headache treatments alongside pharmacologic treatments for primary headache. The present overview was prepared as a companion article to and intended to provide a background for the Guidelines for Trials of Behavioral Treatments for Recurrent Headache also published within this journal supplement. This article begins with a synopsis of key historical developments leading to our current conceptualization of migraine and tension-type headache as psychophysiological disorders amenable to behavioral intervention. The evolution of 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 examining the migraine and tension-type headache literatures are summarized, compared, and contrasted. A critique of the methodological quality of the clinical trials literature is presented, highlighting the strengths and weaknesses in relation to recruitment and selection of patients, sample size and statistical power, the use of a credible control, and the reproducibility of the study interventions in clinical practice.
Behavior Therapy↗
Guidelines for trials of behavioral treatments for recurrent headache, first edition: American Headache Society Behavioral Clinical Trials Workgroup.
Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.
Behavior Therapy↗
Neuropsychology of migraine: present status and future directions.
Migraine is recognized as a primarily neural condition. Changes in neural physiology have been consistently identified in migraineurs. Numerous studies are available that evaluate physical and functional differences between migraineurs and headache-free controls. The most prominent neuroimaging findings reported in migraine sufferers have been white matter changes. However, physical changes on neuroimaging have not been clearly correlated with functional impairment in migraineurs. The current literature addressing the neuropsychologic consequences of migraine has been far from conclusive, and reports of cognitive testing in adult migraineurs and controls has yielded inconsistent results. Neuropsychologic testing suggests that there may be some subtle but possibly significant changes in cognition that occur both during and between migraine episodes. A finding emerging with some consistency is that migraine patients with aura experience more neuropsychologic deficits than migraine patients without aura. The few studies that assess nonmigraine headache suggest that physical changes may not be unique to migraine, although neuropsychologic changes do appear to be limited to migraineurs. An examination of the unmet needs and priorities for future research addressing this important topic is provided.
Cognition Disorders↗
Behavioral interventions for tension-type headache: overview of current therapies and recommendation for a self-management model for chronic headache.
Behavioral treatments (relaxation, biofeedback, cognitive-behavioral therapy) have been empirically validated for migraine and tension-type headaches, with recent meta-analyses yielding 37% to 50% reductions in tension-type headache, comparing favorably with 33% reduction from medication prophylaxis (amitriptyline). Research has moved toward increasing availability and cost effectiveness through alternative delivery formats and combining and comparing them with standard medications. Further modifications would make standard behavioral treatments available and conducive to primary care settings where most patients receive treatment. Beyond the current behavioral and drug treatments, we propose a fundamental shift in conceptualization and treatment for headache.
Behavior Therapy↗
Sleep and chronic pain: challenges to the alpha-EEG sleep pattern as a pain specific sleep anomaly.
OBJECTIVE: The alpha-EEG sleep anomaly has been associated with chronic benign pain syndromes. Although controversial, the anomaly is believed by some to be an important biologic correlate of certain otherwise poorly explained painful conditions (e.g., fibromyalgia and chronic fatigue syndrome). To shed further light on this phenomenon, this study compared the sleep and psychological characteristics of chronic pain patients who exhibited the alpha-EEG sleep anomaly with pain-free psychiatric and medical patients who also were found to exhibit the alpha-EEG anomaly. METHODS: The alpha-EEG sleep was identified in the polysomnographic records of 5% of over 1000 consecutive sleep patients. Objective sleep parameters, daytime sleepiness and psychological characteristics (Minnesota Multiphasic Personality Inventory [MMPI] scores) of patients exhibiting this anomaly were examined. RESULTS: The alpha-EEG anomaly was identified in only 5% of the total patient sample. Patients with the alpha-EEG anomaly could be further classified into three diagnostic subgroups: chronic pain, psychiatric and other medical/sleep disorders, The subgroups were compared on sleep parameters and psychological characteristics. Less than 40% of the patients exhibiting the alpha-EEG anomaly experienced chronic pain. Chronic pain patients evidenced disturbed sleep patterns and psychological characteristics that were for the most part similar to those observed in some pain-free medical and psychiatric patients. Only the medical subgroup exhibited objective daytime sleepiness. The alpha-EEG sleep disturbance was not accounted for by psychological characteristics. CONCLUSIONS: These findings challenge the notion that alpha-EEG sleep is of direct etiological significance in producing the pain complaint among patients with chronic pain since the alpha-EEG sleep was not a sufficient condition for pain.
Adolescent↗
The influence of placebo awareness on stimulant drug response in a double-blind trial.
RATIONALE: Critics have called into question findings from double-blind placebo-controlled studies because subjects are given drug administration instructions informing them of a placebo condition. The assertion that these drug administration instructions bias estimates of effectiveness has undergone surprisingly little empirical investigation. OBJECTIVES: The primary objective of this study was to determine whether drug administration instructions informing subjects of a placebo condition affect the drug response and affect the saliva concentration of the stimulant. METHODS: We assessed caffeine responses and levels of saliva concentration of caffeine in 52 subjects who were randomly assigned to receive one of two drug administration instructions: (a) placebo-informed instructions (i.e., individuals informed of the placebo) analogous to those used in double-blind studies and (b) placebo-uninformed instructions (i.e., individuals informed they are taking an active stimulant). RESULTS: On most measures (systolic blood pressure, heart rate, hand steadiness, reaction time, fatigue, and tension), drug administration instructions did not significantly influence caffeine response. Instructions also had no significant effect on saliva concentration of caffeine. However, only individuals who were uninformed of the placebo condition showed significant diastolic blood pressure and vigor increases with 125 mg caffeine, and significant hand steadiness impairment and vigor increases with 325 mg caffeine compared to placebo. CONCLUSIONS: These overall findings suggest that a limited bias is introduced by drug administration instructions. The results do not support any suggestion that information about the existence of a placebo condition dramatically influences conclusions drawn about drug responses in placebo-controlled trials.
Affect↗
Chronic headache and sleep disturbance.
Headache and sleep disturbance are common health complaints. Both complaints often co-exist in the same patient, leading some to suspect a causal relationship or common underlying pathology. However, the empirical literature in this area is limited. Some attempts have been made to explore the relationship between headache and sleep disturbance, but few consistencies have emerged in the literature. There is no accepted model for understanding the link between headache and sleep disturbance. This paper reviews the available literature concerning comorbid headache and sleep disturbance and offers some preliminary suggestions based on the available literature to guide their evaluation and management. Information specific to the relationship between sleep disturbance and chronic daily headache, where available, is highlighted.
Chronic Disease↗
Behavioral management of recurrent headache: three decades of experience and empiricism.
In the past three decades, behavioral interventions (chiefly relaxation, biofeedback, and stress-management) have become standard components of the armamentarium for management of migraine and tension-type headaches. Meta-analytic literature reviews of these behavioral interventions have consistently identified clinically significant reductions in recurrent headache. Across studies, behavioral interventions have yielded approximately 35-50% reduction in migraine and tension-type headache activity. Although we have only recently begun to directly compare standard drug and nondrug treatments for headache, the available evidence suggests that the level of headache improvement with behavioral interventions may rival those obtained with widely used pharmacologic therapies in representative patient samples. In recent years, some attempts have been made to increase the availability and cost effectiveness of behavioral interventions through alternative delivery formats and mass communications. Recent developments within diagnosis and classification are summarized, pointing out implications for behavioral researchers. Select future directions are discussed, which include impact of the triptans, cost and cost effectiveness, and integration of behavioral treatments into primary care settings, the place where the great majority of headache sufferers receive treatment.
Biofeedback, Psychology↗
Migraine and women's health.
Migraine is a significant women's health concern. Epidemiological research has demonstrated that migraine is one of the most common pain conditions and that women are disproportionately affected. Recent advances in pathophysiology highlight the hormonal antecedents of these sex differences in migraine and the potential influence of hormones on migraine pain pathways. Migraine spawns substantial suffering and disability and gives rise to great economic and personal burden. Despite the availability of effective pharmacological and nonpharmacological treatments, only a fraction of migraine sufferers receive state-of-the-art treatment. Access to effective treatment is limited by economic and social barriers to care, including the long-standing social stigma that trivializes headache. Although doubtless a women's health issue, migraine has been largely overlooked in the women's health initiatives. This paper argues that migraine is an important women's health concern and that greater attention to migraine promises to make a demonstrable improvement in the quality of life of many women.
Adult↗
Cognitive-behavioral classifications of chronic pain: replication and extension of empirically derived patient profiles.
Many attempts have been made to classify patients with chronic pain in order to make sense of a very complex problem and to direct patients towards appropriate treatments for their condition. Unfortunately, these efforts have not been empirically based and have demonstrated limited clinical use. Predominant emphasis has been placed on either biomedical or psychopathological elements of the chronic pain experience with little integration of cognitive-behavioral factors. Turk and Rudy (1988) introduced an empirically derived pain patient taxonomy based on analyses of the Multidimensional Pain Inventory (MPI). The primary purpose of the present study was to replicate this classification system by using different measures for similar constructs in different groups of chronic pain patients. Items designed to measure 4 constructs (activity interference, emotional distress, pain intensity, and perceived support) were collected from 1594 pain patients evaluated at two separate pain treatment facilities. Confirmatory factor analytic results indicated high reliability of the items in measuring these 4 constructs. Replicated clustering techniques demonstrated the robustness of 3 patient profiles across the patient samples. The 3 clusters corresponded remarkably well to the groups initially labeled by Turk and Rudy (1988) as Dysfunctional, Interpersonally Distressed and Adaptive Copers. External validation of the classification system supported replication of the 3 groups and offered further interpretational clarity to the patient profiles. Strong evidence was found for a taxonomy of 3 chronic pain patient groups. Implication for predicting treatment outcome and for future research are discussed.
Adult↗
Pharmacological versus non-pharmacological prophylaxis of recurrent migraine headache: a meta-analytic review of clinical trials.
In order to generate information about the relative effectiveness of the most widely used pharmacological and non-pharmacological interventions for the prophylaxis of recurrent migraine (i.e., propranolol HCl and combined relaxation/thermal biofeedback training), meta-analysis was used to integrate results from 25 clinical trials evaluating the effectiveness of propranolol and 35 clinical trials evaluating the effectiveness of relaxation/biofeedback training (2445 patients, collectively). Meta-analysis revealed substantial, but very similar improvements have been obtained with propranolol and with relaxation/biofeedback training. When daily recordings have been used to assess treatment outcome, both propranolol and relaxation/biofeedback have yielded a 43% reduction in migraine headache activity in the average patient. When improvements have been assessed using other outcome measures (e.g., physician/therapist ratings), improvements observed with each treatment have been about 20% greater. In both cases, improvements observed with propranolol and relaxation/biofeedback have been significantly larger than improvement observed with placebo medication (14% reduction) or in untreated patients (no reduction). Meta-analysis thus revealed substantial empirical support for the effectiveness of both propranolol and relaxation/biofeedback training, but revealed no support for the contention that the two treatments differ in effectiveness. These results suggest that greater attention should be paid to determining the relative costs and benefits of widely used pharmacological and non-pharmacological treatments.
Analysis of Variance↗
Meta-analysis minus the analysis: a prescription for confusion.
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Chronic Disease↗