Development of a measure of self-efficacy for acute headache medication adherence.

Acute medication adherence is essential to manage chronic, episodic disorders, including headache. This paper describes the development of a measure of acute medication self-efficacy for headache (AMSE-H). Phase 1: 14 AMSE-H items were generated through qualitative interviews with 21 patients and 15 clinical headache experts. Phase 2: Researchers selected 7 AMSE-H items by examining item performance in 35 headache patients. Phase 3: Migraine patients (n = 161) completed the AMSE-H, and measures of outcome expectancies, perceived access to medication, headache management self-efficacy (n = 58) and a 1-week AMSE-H re-test (n = 103). Content validity was established through input of multiple stakeholder groups during item generation. PCA identified two components: cross-episode self-efficacy (eigenvalue = 3.4) and Episode-Specific Self-Efficacy (eigenvalue = 1.0). These subscales are internally consistent (.73-.80), have low 1-week test-retest reliability (rs = .52-.66), and demonstrated solid construct and discriminant validity. The AMSE-H is brief, theory-driven, focused, socially valid measure acceptable to both patients and providers.

Behavioral migraine management modifies behavioral and cognitive coping in people with migraine.

OBJECTIVE: This is a secondary analysis of a randomized clinical trial which aims to examine changes in cognitive and behavioral responses to migraine with cognitive behavioral treatment for migraine, preventive medication for migraine, and their combination, and the relationship between these changes and reductions in migraine-related disability. BACKGROUND: Cognitive behavioral treatment is thought to reduce migraine-related disability through modifying maladaptive cognitive and behavioral responses to migraine. METHODS: Two hundred thirty-two people with migraine who did not respond to 5 weeks of optimized acute therapy were randomized into a 2 (beta-blocker vs placebo) X 2 (behavioral migraine management [BMM] vs no BMM) treatment design. Participants received BMM and/or beta-blocker dose adjustment for 4 months, and were followed for an additional 12 months. Participants completed measures of catastrophizing, behavioral coping, and migraine-related disability throughout the study. RESULTS: Compared to drug therapy only, BMM demonstrated larger decreases in catastrophizing scores (19.16 to 9.89 vs 16.78 to 11.84, P < .001) and increases in number of positive coping strategies (proactive: 1.09 to 1.90 vs 1.16 to 1.09, P < .001; anticipatory: 0.19 to 0.69 vs 0.10 to 0.08, P < .001; migraine management: 0.14 to 0.36 vs 0.04 to 0.04, P < .001) at the end of the follow-up period. Decreases in catastrophizing were associated with a larger BMM effect on migraine-related disability (P = .036). CONCLUSIONS: This study demonstrated that BMM modified important cognitive and behavioral factors postulated to be mechanisms of cognitive behavioral treatments for migraine.

Influence of family psychiatric and headache history on migraine-related health care utilization.

OBJECTIVE: We sought to examine the relationship of family history of headache and family history of psychiatric disorders on self-reported health care utilization tendencies for migraine treatment. BACKGROUND: Familial aggregation of both migraine and depression has been well established in the literature. Family history of headache and psychiatric disorders could influence health care utilization tendencies for migraine. METHODS: This is a secondary analysis of patients with severe migraine (n = 225) who answered questions about their family history, previous headache treatment history, disability (Headache Disability Inventory), and psychiatric symptoms (Beck Depression Inventory and Beck Anxiety Inventory). Using regression, we examined the relationship between family history of headache, depression, and anxiety and reported headache-related health care utilization. RESULTS: Participants reported family histories of headache (67.6%), anxiety (15.6%), and depression (29.3%). Participants reported seeing a physician for headache an average of 3.1 (standard deviation = 3.8) times in the past 2 years. In a 2-year period, 27.6% of participants reported seeing a general practitioner and 18.5% of participants reported seeing a neurologist. Twenty-eight percent of participants went to urgent care for headaches at least once in the last 2 years. Thirty-nine percent of participants reported using non-pharmacologic treatment for headache in the prior 2 years, with the highest rates of chiropractic manipulation (27.1%) and massage (18.2%), and fewest rates of biofeedback (0.4%), relaxation training (4.4%), psychotherapy (1.8%), physical therapy (4.9%), or acupuncture (1.8%). Family history of anxiety was associated with trying non-pharmacologic treatments for headache, but no other self-reported health care utilization variable. However, neither family history of headache nor family history of depression was associated with self-reported health care utilization tendencies. Headache Disability Inventory was associated with self-reported non-pharmacologic treatments for headache. CONCLUSIONS: Family history of anxiety, but not depression, was associated with utilizing non-pharmacologic treatments for headache. Also, disability was associated with utilizing non-pharmacologic treatments for headache. However, participants reported low rates of utilization for non-pharmacologic treatments with grade-A evidence.

Optimal use of acute headache medication: a qualitative examination of behaviors and barriers to their performance.

OBJECTIVE: This study aims to qualitatively examine the behaviors required to optimally use acute headache medication and the barriers to successful performance of these behaviors. BACKGROUND: The efficacy of drug treatment is partly determined by medication adherence. The adherence literature has focused almost exclusively on the behaviors required to optimally use medications that are taken on a fixed schedule, as opposed to medications taken on an as needed basis to treat acute episodes of symptoms, such as headaches. METHODS: Twenty-one people with headache and 15 health care providers participated in qualitative phenomenological interviews that were transcribed and coded by a multidisciplinary research team using phenomenological analysis. RESULTS: Interviews revealed 8 behaviors required to optimally use acute headache medication, including cross-episode behaviors that people with headache regularly perform to ensure optimal acute headache medication use, and episode-specific behaviors used to treat an individual headache episode. Interviews further revealed 9 barriers that hinder successful performance of these behaviors. CONCLUSIONS: Behaviors required to optimally use acute headache medication were numerous, often embedded in a larger chain of behaviors, and were susceptible to disruption by numerous barriers.

Psychiatric comorbidity and response to preventative therapy in the treatment of severe migraine trial.

INTRODUCTION: Mood and anxiety disorders are comorbid with migraine and commonly assumed to portend a poor response to preventive migraine therapies. However, there is little evidence to support this assumption. METHOD: We examined impact of a mood and/or anxiety disorder diagnosis using American Psychiatric Association Diagnostic and Statistical Manual criteria on response to the three preventative migraine therapies evaluated in the Treatment of Severe Migraine trial (n = 177): ß-blocker, behavioral migraine management, or behavioral migraine management +ß-blocker. Daily diaries assessed migraine activity for the 16 months of the trial. The Migraine Specific Quality of Life Questionnaire and Headache Disability Inventory assessed headache-related disability at regular intervals. Mixed models for repeated measures examined changes in these three outcomes with preventative migraine therapy in participants with and without a mood or anxiety disorder diagnosis. RESULTS: Participants with a comorbid mood or anxiety disorder diagnosis recorded larger reductions in migraine days (p < .05) and larger reductions in the Migraine Specific Quality of Life Questionnaire (p < .001) and Headache Disability Inventory (p < .01) than did participants with neither diagnosis. DISCUSSION: Significantly larger reductions in migraine activity and migraine-related disability were observed in participants with a mood and/or anxiety disorder diagnosis than in participants who did not receive either diagnosis.

Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial.

OBJECTIVE: To determine if the addition of preventive drug treatment (ß blocker), brief behavioural migraine management, or their combination improves the outcome of optimised acute treatment in the management of frequent migraine. DESIGN: Randomised placebo controlled trial over 16 months from July 2001 to November 2005. SETTING: Two outpatient sites in Ohio, USA. PARTICIPANTS: 232 adults (mean age 38 years; 79% female) with diagnosis of migraine with or without aura according to International Headache Society classification of headache disorders criteria, who recorded at least three migraines with disability per 30 days (mean 5.5 migraines/30 days), during an optimised run-in of acute treatment. INTERVENTIONS: Addition of one of four preventive treatments to optimised acute treatment: ß blocker (n=53), matched placebo (n=55), behavioural migraine management plus placebo (n=55), or behavioural migraine management plus ß blocker (n=69). MAIN OUTCOME MEASURE: The primary outcome was change in migraines/30 days; secondary outcomes included change in migraine days/30 days and change in migraine specific quality of life scores. RESULTS: Mixed model analysis showed statistically significant (P≤0.05) differences in outcomes among the four added treatments for both the primary outcome (migraines/30 days) and the two secondary outcomes (change in migraine days/30 days and change in migraine specific quality of life scores). The addition of combined ß blocker and behavioural migraine management (-3.3 migraines/30 days, 95% confidence interval -3.2 to -3.5), but not the addition of ß blocker alone (-2.1 migraines/30 days, -1.9 to -2.2) or behavioural migraine management alone (-2.2 migraines migraines/30 days, -2.0 to -2.4), improved outcomes compared with optimised acute treatment alone (-2.1 migraines/30 days, -1.9 to -2.2). For a clinically significant (≥50% reduction) in migraines/30 days, the number needed to treat for optimised acute treatment plus combined ß blocker and behavioural migraine management was 3.1 compared with optimised acute treatment alone, 2.6 compared with optimised acute treatment plus ß blocker, and 3.1 compared with optimised acute treatment plus behavioural migraine management. Results were consistent for the two secondary outcomes, and at both month 10 (the primary endpoint) and month 16. CONCLUSION: The addition of combined ß blocker plus behavioural migraine management, but not the addition of ß blocker alone or behavioural migraine management alone, improved outcomes of optimised acute treatment. Combined ß blocker treatment and behavioural migraine management may improve outcomes in the treatment of frequent migraine. TRIAL REGISTRATION: Clinical trials NCT00910689.

Dynamics of changes in self-efficacy and locus of control expectancies in the behavioral and drug treatment of severe migraine.

BACKGROUND: Modification of expectancies (headache self-efficacy and headache locus of control) is thought to be central to the success of psychological treatments for migraine. PURPOSE: The purpose of this study is to examine expectancy changes with various combinations of Behavioral Migraine Management and migraine drug therapies. METHODS: Frequent migraine sufferers who failed to respond to 5 weeks of optimized acute migraine drug therapy were randomized to a 2 (Behavioral Migraine Management+, Behavioral Migraine Management-) × 2 (ß-blocker, placebo) treatment design. RESULTS: Mixed models for repeated measures analyses (N = 176) revealed large increases in headache self-efficacy and internal headache locus of control and large decreases in chance headache locus of control with Behavioral Migraine Management+ that were maintained over a 12-month evaluation period. Chance headache locus of control and socioeconomic status moderated changes in headache self-efficacy with Behavioral Migraine Management+. CONCLUSIONS: The "deficiency" hypothesis best explained how patient characteristics influenced changes in of headache self-efficacy with Behavioral Migraine Management.

Do psychiatric comorbidities influence headache treatment outcomes? Results of a naturalistic longitudinal treatment study.

This study examined if the presence of one or more psychiatric disorders influences headache treatment outcomes in patients in headache specialty treatment centers. Using a naturalistic, longitudinal design, 223 patients receiving preventive therapy for headache disorders completed 30-day daily diaries that assessed headache days/month and severity at acute therapy baseline and 6-month evaluation and also provided data on headache disability and quality of life at acute therapy baseline, preventive therapy initiation, preventive therapy adjustment, and 6-month evaluation visits. Psychiatric diagnoses were determined using the Primary Care Evaluation for Mental Disorders (PRIME MDs). Of the 223 patients, 34% (n = 76) had no psychiatric disorder, 21% (n = 46) were diagnosed with Depression-Only; 13% (n = 29) were diagnosed with Anxiety-Only; and 32% (n = 72) were diagnosed with Depression-and-Anxiety. Prior to initiating new preventive therapy, patients with one or more psychiatric disorders reported more frequent and disabling headaches and poorer life quality compared to patients with no psychiatric disorders. Rates of improvement in headache days/month, disability, and quality of life were significant and comparable across the four groups. Contrary to clinical wisdom, patients with psychiatric disorders respond very favorably to contemporary headache treatments administered in headache specialty treatment centers.

Moderation and mediation in the psychological and drug treatment of chronic tension-type headache: the role of disorder severity and psychiatric comorbidity.

We evaluated two putative moderators of treatment outcome as well as the role of Headache Management Self-Efficacy (HMSE) in mediating treatment outcomes in the drug and non-drug treatment of chronic tension-type headache (CTTH). Subjects were 169 participants (M=38 yrs.; 77% female; M headache days/mo.=22) who received one of four treatments in the treatment of CTTH trial (JAMA, 2001; 285: 2208-15): tricyclic antidepressant medication, placebo, (cognitive-behavioral) stress-management therapy plus placebo, and stress-management therapy plus antidepressant medication. Severity of CTTH disorder and the presence of a psychiatric (mood or anxiety) disorder were found to moderate outcomes obtained with the three active treatments and with placebo, as well as to moderate the role of HMSE in mediating improvements. Both moderator effects appeared to reflect the differing influence of the moderator variable on each of the three active treatments, as well as the fact that the moderator variables exerted the opposite effect on placebo than on the active treatments. HMSE mediated treatment outcomes in the two stress-management conditions, but the pattern of HMSE mediation was complex, varying with the treatment condition, the outcome measure, and the moderator variable. Irrespective of the severity of the CTTH disorder HMSE fully mediated observed improvements in headache activity in the two stress-management conditions. However, for patients with a mood or anxiety disorder HMSE only partially mediated improvements in headache disability, suggesting an additional therapeutic mechanism is required to explain observed improvements in headache disability in the two stress-management conditions.

Race differences in adherence to headache treatment appointments in persons with headache disorders.

PURPOSE: This research characterized patterns and predictors of adherence to headache treatment appointments in patients presenting at headache specialty treatment clinics throughout Ohio. BASIC PROCEDURES: Participants were 186 patients (118 white, 68 African Americans, 89% female) in headache treatment clinics in Cincinnati, Cleveland, Columbus and Toledo, OH. The study used a naturalistic longitudinal cohort design and assessed patients during four treatment visits (pretreatment, one-month follow-up, two-month follow-up and six-month follow-up). During the 30 days prior to initiating new headache treatments, patients used a daily diary to record data on headache severity, frequency and disability; headache treatment locus of control and headache management self-efficacy; social support; and demographic characteristics. The Primary Care Evaluation for Mental Disorders interview was administered to all patients at pretreatment to screen for psychiatric diagnoses. Patient attendance at the four treatment appointments was used to create a dichotomous measure of treatment appointment adherence (i.e., 0 = completed treatment; 1 = terminated treatment prematurely). MAIN FINDINGS: African Americans were more likely to be diagnosed with depression than whites and were more likely to prematurely terminate their headache treatment appointments regardless of their socioeconomic status (SES). White patients with SES values above the median reported the lowest rate of premature treatment termination. PRINCIPAL CONCLUSIONS: Higher SES enables whites (but not African Americans) to attend all headache treatment appointments. Interventions that enable African-American headache patients to complete their prescribed headache treatments are urgently needed.

Tension-type headache and psychiatric comorbidity.

Much of the contemporary literature on headache disorders focuses on migraine headaches, despite the fact that tension-type headache (TTH) is highly prevalent and can be as debilitating as migraines. This article reviews the current literature on prevalence rates of psychiatric disorders in TTH populations, psychologic factors associated with TTH, and psychiatric disorders and their relationships with treatment outcomes in TTH. Key conclusions of this review include 1) prevalence rates of TTH vary across clinical and population-based samples; 2) greater TTH chronicity is associated with increased affective distress; 3) Axis II personality disorders may play an important role in TTH prevalence rates and psychologic functioning but have been understudied to date; and 4) maladaptive coping is common in persons with TTH.

Basic principles and techniques of cognitive-behavioral therapies for comorbid psychiatric symptoms among headache patients.

Recent research on headache has focused on identifying the prevalence of psychiatric disorders in headache patients and discerning the impact of psychiatric comorbidity on treatment of headache. The presence of comorbid psychiatric disorders, especially anxiety and depression, in headache patients is now a well-documented phenomenon. Existing but limited empirical data suggest that psychiatric comorbidity exacerbates headache and negatively impacts treatment of headache. Problematically, these findings have not yet eventuated in improved treatments for individuals suffering from both headache and a psychiatric disorder(s). The present article is an attempt to describe the application of cognitive-behavioral therapies (CBT) for depressive and anxiety disorders to headache patients who present with psychiatric comorbidity. We discuss the origins of the chronic care model in relation to CBT, review basic cognitive-behavioral principles in treating depression and anxiety, and offer clinical recommendations for integrating CBT into existing headache treatment protocols. Directions for future research are outlined, including the need for treatment outcome studies that examine the effects of treating comorbid psychiatric disorders on headache (and vice versa) and the feasibility of developing an integrated CBT protocol that addresses both conditions simultaneously.

Behavioral approaches to the treatment of migraine.

Behavioral interventions such as biofeedback training, relaxation training, and cognitive-behavior stress management therapy have been identified as efficacious treatments for migraine headache. These treatments, and the formats (clinic-based, limited-contact, and home-based) in which they are taught, are described in this article. Information about public health interventions (school, work, Internet, and mass media) is also briefly addressed. Results of studies examining the efficacy of behavioral treatments, how behavioral treatments compare in effectiveness, and how they can be integrated with pharmacotherapy are reviewed for both adult and pediatric populations. Finally, the role of behavioral treatments in migraine treatment guidelines is discussed, and factors that are associated with response to behavioral treatments are reviewed.

A self-management program for adult asthma: part IV, Analysis of context and patient behaviors.

Patient behaviors performed in the self-management of asthma have been investigated by use of black box theory as a model for examining behavioral change. Consequently, the context within which patients learn and perform processes of self-management has been ignored. The purpose of the present study was to investigate contextual and behavioral elements that comprise the management of asthma attacks by a large number of adult patients. A total of 3442 reports of attack were obtained from 90 subjects, including 76 patients described in the article by Kotses and colleagues, 9 who dropped out of the study, and 5 who served as pilot subjects. The major focus of the analysis, however, was on the 63 subjects who submitted forms during two periods: intake/baseline and training/after training. Data included information about the episode (e.g., severity, duration, etc.), prior actions taken by patients (e.g., adherence to treatment regimens, collection of peak flow data, etc.), and the impact of contextual variables (e.g., setting where attack occurred, time when attack occurred, etc.) on patient behaviors The variables were subjected to a probability analysis to demonstrate changes in the probability of responses as influenced by contextual variables present during any given attack. The results indicated that contextual variables affect behavioral change. Changes occurred in actions taken to manage an attack in the two periods, intake/baseline and during and after training. Three findings are of interest. The first was the emergence of discriminative stimuli that because they were present when self-management skills were initially reinforced, altered the future probability of performance of the skills. Peak flow values and asthma action plans qualified as discriminative stimuli in that their use often prompted patients to perform steps to alleviate and abort episodes. Second, several processes comprise self-management, ranging from goal setting to self-appraisal of one's actions. Self-monitoring is the backbone of self-management. However, what emerged from the current study is the importance of two other processes: 1) information collection and processing and 2) decision making. When subjects were introduced to self-monitoring via use of peak flow meters, an asthma diary, and a report of an attack, they began using these tools, often in a trial-and-error manner, to match the information they obtained to the actions they took. As a result, they became skilled at self-monitoring prior to training. During and after training, however, patients indicated they were skilled at processing and making decisions based on the data they collected. Finally, stimuli present during an attack came to prompt distinctive patterns whereby individual patients considered the reciprocal interaction of environmental, physiological, behavioral, and cognitive variables to control attacks. Action taken by patients reflected data processing and decision making on the part of patients in selecting and performing those self-management skills they anticipated would generate the best outcomes.

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.

Methodological issues in clinical trials of drug and behavior therapies.

Trials that compare drug and behavior therapies or evaluate combination therapy raise special methodological issues. This article reviews these methodological issues and, where possible, offers guidelines for addressing them. Sources of bias in the selection and recruitment of participants and in the measurement of treatment outcomes are discussed. In addition, methodological problems presented by the differing structures of behavior and drug therapy, by confounding variables, such as allegiance effects, differential expectations and preferences for drug or behavior therapy, and differential adherence with drug or behavior therapy also are reviewed. Issues in the selection of appropriate control groups are also discussed.

Depression increases onset of tension-type headache following laboratory stress.

The aim of this study is to examine the influence of depression on headache onset following laboratory stress and on psychophysiological variables associated with tension-type headaches (TTHs). Diagnostic interviews identified three groups: headache prone and depressed (HP/D, N = 13); headache prone not depressed (HP/ND, N = 22); and healthy controls (HC, N = 13). Ss completed a laboratory stress task. Blind evaluations of pericranial muscle tenderness (PMT) and pressure pain thresholds (PPT) were obtained immediately before, immediately after and 24 h post-task. Ss also recorded headaches (HA) before, during, immediately post-task and for 24 h post-task. HP/D Ss were more likely than HP/ND Ss or HC Ss to report a headache during and immediately following the stress task (P < 0.05). HP/D Ss exhibited higher PMT than HP/ND Ss or HC Ss before and following the stress task (P < 0.05). HP/D Ss exhibited lower finger PPT at all assessments and lower temporalis PPT at two of three assessments than HC Ss (P < 0.05) but did not significantly differ from HP/ND Ss at most assessments. Depression increased vulnerability to TTH following laboratory stress and was associated with elevated PMT. In individuals with frequent headaches, depression may aggravate existing central sensitization increasing vulnerability to TTHs.