Medium-term effectiveness of online behavioral training in migraine self-management: A randomized trial controlled over 10 months.

AIM: This randomized, controlled trial examined the medium-term effectiveness of online behavioral training in migraine self-management (oBT; N = 195) versus waitlist control (WLC; N = 173) on attack frequency, indicators of self-management (primary outcomes), headache top intensity, use of rescue medications, quality of life and disability (secondary outcomes). METHODS: An online headache diary following the ICHD-II and questionnaires were completed at baseline (T0), post-training (T1) and six months later (T2). Missing data (T1: 24%; T2: 37%) were handled by multiple imputation. We established effect sizes (ES) and tested between-group differences over time with linear mixed modelling techniques based on the intention-to-treat principle. RESULTS: At T2, attack frequency had improved significantly in oBT (-23%, ES = 0.66) but also in WLC (-19%; ES = 0.52). Self-efficacy, internal and external control in migraine management--and triptan use--improved only in oBT, however. This indicates different processes in both groups and could signify (the start of) active self-management in oBT. Also, only oBT improved migraine-specific quality of life to a sizable extent. CONCLUSIONS: oBT produced self-management gains but could not account for improved attack frequency, because WLC improved as well. The perspective that BT effects develop gradually, and that online delivery will boost BT outreach, justifies further research.

Migraine patients as trainers of their fellow patients in non-pharmacological preventive attack management: short-term effects of a randomized controlled trial.

In conformity with current views on patient empowerment, we designed and evaluated the effects of home-based behavioural training (BT) provided by lay trainers with migraine to small groups of fellow patients. The primary aims of BT were to reduce attack frequency and increase perceived control over and self-confidence in attack prevention. In a randomized controlled trial the BT group (n = 51) was compared with a waitlist-control group (WLC), receiving usual care (n = 57). BT produced a minor (-21%) short-term effect on attack frequency and clinically significant improvement in 35% of the participants. Covariance analysis showed a non-significant trend (P = 0.07) compared with WLC. However, patients' perceived control over migraine attacks and self-confidence in attack prevention increased significantly with large effect sizes. Patients with high baseline attack frequency might benefit more from BT than those with low attack frequency. In conclusion, lay trainers with migraine strengthened fellow patients' perceived control, but did not induce a significant immediate improvement in attack frequency.

Emotion regulation predicts change of perceived health in patients with rheumatoid arthritis.

OBJECTIVES: To examine whether emotion regulation predicts change of perceived health in patients with rheumatoid arthritis (RA). METHODS: Sixty six patients (44 female, 22 male; mean (SD) age 57.7 (11.6) years) participated in a prospective study. Hierarchical regression analysis was used to predict change of perceived health between study entry and follow up (1(1/2) years later) from the emotion regulation styles ambiguity, control, orientation, and expression at study entry. RESULTS: Valuing and intensely experiencing emotions (emotional orientation) predicted a decrease of positive affect. Difficulty recognising and expressing emotions (ambiguity) predicted an increase of perceived disease activity. Emotion regulation showed no associations with change of negative affect and social and physical functioning. CONCLUSIONS: Two styles of emotion regulation were shown to have a significant though modest role in the prediction of perceived health change in patients with RA. This suggests that the monitoring of emotion regulation may help to identify patients who are at risk for a reduction of perceived health. If our findings were confirmed by experimental research, improving emotion regulation skills might favourably affect perceived health.

Neuroendocrine-immune relationships between emotion regulation and health in patients with rheumatoid arthritis.

OBJECTIVES: Emotion regulation is hypothesized to be related to health through neuroendocrine-immune changes. This study examined the role of the neuroendocrine variables 24-h urinary cortisol and noradrenaline, and the immune variable serum interleukin 6 as mediators between emotion regulation styles and health (perceived health and disease activity: erythrocyte sedimentation rate (ESR) and Thompson joint score). METHODS: Sixty patients with rheumatoid arthritis (mean age 59.0+/-11.2 yr; 38 female) participated. RESULTS: Emotion regulation was not associated with immune functioning or disease activity, but it was somewhat related to neuroendocrine functioning: one of the emotion regulation styles, ambiguity, was related to noradrenaline in women (r = 0.39) but not in men. The indicators of neuroendocrine functioning (cortisol and noradrenaline) were correlated (r = 0.40), as were indicators of immune functioning (interleukin 6) and inflammatory activity (ESR; r = 0.53), but analyses did not indicate a role of these physiological variables in mediating between emotion regulation and health: neuroendocrine variables were not related to interleukin 6 or ESR, and none of the physiological parameters was correlated with joint score or perceived health. CONCLUSIONS: To examine whether the proposed mediational processes apply to individual patients, a longitudinal within-subjects design is needed. In our cross-sectional study, emotion regulation was somewhat related to neuroendocrine functioning, but our study did not uncover a potential mediational role of cortisol, noradrenaline or interleukin 6 in the relationship between emotion regulation and health in rheumatoid arthritis.

Warfarin and aspirin versus aspirin alone in patients with acute myocardial infarction: a pilot study.

The benefits of anticoagulant therapy and antiplatelet agents in secondary prevention of myocardial infarction (MI) are well known. Administration of combined warfarin and aspirin (ASA) has not been well studied. The objective of this study was to compare the effect of coadministration of warfarin and ASA with administration of ASA alone on outcome of patients after MI. One hundred forty age- and sex-matched survivors of MI were randomized to receive either 100 mg/day ASA plus enough warfarin to reach a target: international normalized ratio of 2.5 (range: 2-3) (group A, n = 70), or only 100 mg/day ASA (group B, n = 70). The patients were examined for several variables including development of hemorrhage, reinfarction, and rehospitalization for 1 year post MI. Of the variables studied, minor hemorrhagic episodes were observed significantly (p = 0.002) more in group A than in group B patients. Rehospitalization and reinfarction rates, although occurring with lower frequencies in group A than in group B, did not reach the statistical significance level. In postmyocardial infarction patients, warfarin plus ASA did not provide a clinical benefit beyond that achievable with aspirin monotherapy, and for the observed markedly higher incidence of minor hemorrhage in combination therapy, antiplatelet therapy alone seems to be a more reasonable approach.

Unexplained severe chronic pain in general practice.

The aim of this study was to estimate the prevalence of unexplained severe chronic pain (USCP) in general practice and to report medical as well as psychological descriptions of patients suffering from this condition.A total of 45 GPs in 35 different practices included patients throughout the year 1996. Patients were included according to the following criteria: between 18 and 75 years of age; pain which had lasted at least 6 months; pain is the most prominent aspect in the clinical presentation; pain is serious enough to justify clinical attention; pain has led to obvious discomfort and disability in daily life for at least for 1 month. Medical aspects were measured with the IASP taxonomy while psychological aspects were derived from the MPI. The overall prevalence of USCP was 7.91 per 1000 enlisted patients. Estimates ranged between 1.87 in the youngest age group and 13.50 in the 55-59 age category. The lower back and lower limbs were most frequently affected and 31% of the patients had pain in more than three major body sites. Pain was most frequently associated by the musculoskeletal system and most often (nearly) continuous. Mean severity of current pain was 3.7 on a scale from 0 (indicating no pain) to 6 (indicating a lot of pain). Mean rating of 'average pain in the last week' was 4.1. Regarding the psychosocial and behavioural aspects of pain, 27% of the patients could be described as perceiving severe pain while gaining social support for it. Fourteen per cent felt in the category 'pain combined with affective and relational distress' and 10% was classified as 'coping well with pain intensities lower than those of the other groups'. The other half of the patients were on average or not classifiable on these aspects. Unexplained severe chronic pain lasting more than 6 months had on overall prevalence of 7.91 per 1000 enlisted patients, ranging from 1.87 in the youngest to 13.50 in the oldest patients in these 35 general practices in The Netherlands. Our prevalence estimate of USCP is low compared to other studies on chronic pain. Probably for three reasons: Firstly, our study was confined to unexplained pain and not all chronic pain. Secondly, our inclusion criteria focused the attention of very severe chronic pain patients, and thirdly, we have defined 'chronic' as more than 6 months, while others have been using shorter time spans.

Electronic diary assessment of pain, disability and psychological adaptation in patients differing in duration of pain.

Computerized diary measurement of pain, disability and psychological adaptation was performed four times a day for 4 weeks in 80 patients with various duration of unexplained pain. Reported are (1) the temporal characteristics and stability of pain report during the 4-week measurement period, (2) the association between pain duration and pain report, disability and general psychopathology, and (3) the accordance between diary assessment versus questionnaire assessment of pain, disability and psychological adaptation. No evidence of instrument reactivity was found: pain report was stable across the 4-week period. However, pain report appeared to be highly variable both between and within days. About half the patients showed a clear increasing trend in pain during the day. Several differences were found between subgroups of patients varying in pain duration. Patients with less than 6 months of pain reported significantly less pain intensity, disability and fatigue than patients whose pain persisted for more than 6 months. Pain coping and responses to pain behaviors by the spouse also differed for the subgroups: longer pain duration was associated with increased catastrophizing and solicitous responses from the spouse. Comparison of scores obtained with diary versus questionnaire assessment indicated moderate correlations for most variables. Retrospective (questionnaire) assessment of pain intensity yielded significantly higher pain scores than diary assessment.

High-density assessment of the IHS classification criteria for migraine without aura: a prospective study.

Fifty-six adult female patients with the clinical diagnosis of MwoA kept a diary 6 times per day for 10 consecutive weeks to record the occurrence, pain characteristics, and accompanying symptoms of headache. In order to avoid bias due to retrospection or expectancy the diary was programmed into palmtop computers which signaled the patients with a beep to enter the diary with a random-fixed time schedule: two signals occurred in, respectively, the morning, the afternoon, and the evening, but at different times for each day. The palmtop computers also warranted flawless data storage and automatic computations of response delay and missing values. Of the 339 attacks, 75% had a duration of 4-72 h and 94% confirmed the International Headache Society classification criteria for MwoA concerning pain characteristics and accompanying symptoms. Our results obtained for attacks in treated patients are highly comparable with the results of Rasmussen, Jensen, and Olesen (1991) obtained in the general population with unknown treatment of headache. Together, both studies support the IHS classification criteria for MwoA. The electronic Experience Sampling Method also allowed for an unbiased description of the course of treated MwoA attacks: 67% subsided in the first day. In the 16 attacks the characteristics and accompanying symptoms were present in 60-80% of the attacks at the first assessment (9.30 a.m.) with the exception of moderate to severe pain intensity (37%) and nausea or vomiting (31%). A waxing and waning of characteristics and symptoms over the day remained in about 30-40% of the attacks with a tendency towards increases in the evening (7.30 p.m. and 10 p.m.). The method is there for a replication of this study in untreated MwoA patients.

Presentation of chronic daily headache: a clinical study.

We studied the presentation of chronic daily headache in 258 patients from a private headache practice, 50 men and 208 women. Chronic daily headache was defined as headaches, occurring at least 5 days per week for at least 1 year. Seventy-seven percent of the patients experienced the onset of headache before the age of 30. The daily headaches were present on awakening in the morning or came about in the course of the morning in 79% of the patients. In 53%, they were worst in the afternoon or evening. The headaches awoke the patients at night at least once per week in 36%. At least twice per week, they were associated with nausea in 35% of the patients and with vomiting in 9%. Common aggravating factors included light, physical activity, bending over, noise, stress or tension, and menstruation. Ninety-four percent of the patients experienced severe headaches in addition to the daily headaches. In 63%, the severe headaches occurred 10 days per month or less. The daily caffeine intake of the patients averaged 170 mg, and the daily analgesic intake, 1860 mg of aspirin equivalents.

Development of chronic daily headache: a clinical study.

We studied the development of chronic daily headache in 258 headache practice patients, 50 men and 208 women. Chronic daily headache was defined as headaches occurring at least 5 days per week for at least 1 year. Twenty-two percent of the patients had daily headaches from the onset, and 78% initially experienced intermittent headaches. Of the patients with initially intermittent headaches, 19% experienced an abrupt transition into daily headaches and 81% a gradual one. The distribution of the age of daily headache onset was the same in the patients with daily headaches from the onset and in those with initially intermittent headaches but with abrupt transition into daily headaches. The distribution of the circumstances of daily headache onset was also the same in the groups. The most common circumstance of abrupt onset of daily headaches was head, neck, or back injury, in 61% caused by a motor vehicle accident. In the patients with initially intermittent headaches but with gradual transition into daily headaches, the transition took an average of 10.7 years.

Accuracy of children's pain memories.

Despite its importance in clinical practice, little research has examined memory for pain in children. This prospective study tried to justify the use of children's pain recall in clinical practice. The purpose of this study was to (a) investigate the accuracy of children's recall of their worst and average pain intensity when controlling for the effects of repeated pain measurement and (b) examine the influence of children's anxiety, age, general memory ability and pain coping strategies on this accuracy. The accuracy of children's recalled pain intensities was studied in 55 inpatients aged 5-16 years by comparing the level of recorded pain intensity with the level of recalled pain intensity 1 day and 1 week after recording using Bieri's Faces Pain Scale. The accuracy of children's recalled pain intensities was high and showed little decrement over 1 week. Older children had more accurate recall of their worst pain intensity. Anxiety, general memory ability and pain coping strategies were not related to accuracy of recalled pain intensities.

Effects of a mass media behavioral treatment for chronic headache: a pilot study.

This article presents the results of a pilot study evaluating the efficacy of a mass media self-help behavioral treatment program for chronic headache. The program consisted of a self-help textbook, an exercise book, 10 television programs, 11 radio programs, and 3 audiocassettes with relaxation training. Approximately 15,000 headache sufferers purchased the book and relaxation tapes. A random sample of 271 respondents participated in the effect study; the pretraining and posttraining data of 164 subjects were available for analysis. Multivariate testing of the pretraining and posttraining results showed highly significant reductions in headache activity and medication intake at 4-month follow-up. A reduction of 50% or more in headache parameters and medication intake was achieved by 40% to 60% of the patients. Work absenteeism was significantly reduced. The differences between the diagnostic groups were not significant. Mass media behavioral treatment seems to be a viable treatment alternative for chronic headache and highly promising in terms of gain in quality of life, decrease in economic loss, and cost-effectiveness in health care.

Psychophysical precedents of migraine in relation to the time of onset of the headache: the migraine time line.

We conducted a prospective study of 19 female migraine patients who kept a diary four times per day at 8 AM, 1 PM, 6 PM, and 11 PM for 10 consecutive weeks. In the diary, the patients recorded the occurrence as well as the features and associated symptoms of their headaches. They also rated five mood states: alertness, tension, irritability, depression, and fatigue, as well as the quality of sleep and the incidence and stressfulness of daily hassles as measurements of stress. They quantified the variables through the use of 100-mm visual analog scales. In the diaries, we identified 68 migraine headaches of which 23 developed during the night, 19 during the morning, 16 during the afternoon, and 10 during the evening. The headaches which developed during the evening or night were preceded by an increased incidence of daily hassles during the afternoon. The headaches which developed during the morning or afternoon were preceded by increased tension the previous days. The day before the headaches which developed during the morning, the incidence of daily hassles was increased during the morning, afternoon, and evening. The increased tension at 1 PM was followed by increased fatigue at 6 PM, which was still present at 8 AM of the morning during which the headaches developed. The day before the headaches which developed during the afternoon, the increased tension at 6 PM was followed by increased alertness at 11 PM. The next morning, the stressfulness of daily hassles was increased at 8 AM, followed by increased tension and irritability at 1 PM. We conclude that there are three different sequences of events with regard to the psychophysical precedents of migraine, depending on the time of onset of the headache: the migraine time line.

A time series analysis of daily hassles and mood changes in the 3 days before the migraine attack.

Daily hassles, mood changes, and sleep quality in the 3 days preceding migraine attacks were prospectively studied and compared with migraine-free control days. Nineteen female migraine patients, aged 20 to 49 years, kept a 10-week diary four times per day and produced complete data on daily hassles (incidence and stressfulness), mood (alert, tense, irritable, annoyed, depressed, and tired), sleep quality, and migraine. Significant results indicated increased hassles, particularly in the 24 premigraine hours; psychological arousal (increased irritability, annoyance, and tenseness), predominantly from 60 to 24 hours before the attack; repeated fatigue in the 60 premigraine hours, with a peak immediately before the attack; and a sharp decrease in sleep quality in the night preceding the attack. The authors also found that those attacks that came on during phases of heightened activity--particularly in the afternoon--were preceded by more substantial and more significant elevations of hassles and psychological arousal than were attacks that occurred during unwinding phases, particularly at night.

Changes in daily hassles, mood, and sleep in the 2 days before a migraine headache.

OBJECTIVE: The determination of the changes in the incidence and stressfulness of daily hassles as well as in the mood states: alert, tense, irritable, annoyed, depressed, and tired and in the quality of sleep in the 2 days before a migraine headache. DESIGN: Prospective cohort study. SETTING: Private headache practice. PATIENTS: Twenty female migraine patients. INTERVENTIONS: Diary four times per day for 10 consecutive weeks with the variables quantified through the use of 100-mm visual analogue scales. RESULTS: The incidence and stressfulness of daily hassles as well as the mood states: tense, irritable, annoyed, depressed, and tired were significantly increased in the 2 days before a migraine headache in comparison to control days. CONCLUSIONS: The results confirm previous studies that daily hassles are increased in the days before a migraine headache. They also show that the increase in daily hassles is associated with mood changes, particularly consisting of tension and depression.

Long-term effects of training in relaxation and stress-coping in patients with migraine: a 3-year follow-up.

Research on the short-term effects of psychological interventions in migraine indicates improvement rates of 50 percent. Yet long-term follow-ups are scarce: the studies extending to three years provide evidence for the maintenance of effects, but these studies evaluate the benefits of rather complex psychological treatments and the samples include other types of headache. We compared the effects of single-method psychological interventions upon migraine. The study reports results obtained from 24 patients three years after completion of relaxation training, which is a psychophysiological regimen, and stress-coping training, which is a cognitive-behavioral regimen. Results for the complete sample, excluding data biased by confounding factors, provide clear evidence of the preservation of effects in migraine. Relaxation training (RT) and stress-coping training (SCT) were equally effective and both groups exhibited little medication consumption since completion of training. Among the secondary effects, SCT was found to improve assertiveness and active problem solving, and to decrease depressive reaction. The study yielded two predictor variables--little external stress for relaxation training, and high self motivation for stress-coping training--that accounted for more than 50 percent of the effect variance in the respective groups. Although more research is needed to substantiate our findings, the results suggest that, thus far, there is little reason to favor multimodal training or more complex psychological treatments over single-method psychological interventions in migraine. Also, our results do not support the assumed superiority of cognitive-behavioral treatment over psychophysiological treatment. Research on factors predicting long-term effects of psychological interventions in migraine may profit from considering separate variables on skill rehearsal and skill employment (instead of employing a global measure of home practice), and from a measure for post-training external stress.

Stress-coping in migraine.

During a total of six months weekly measurements of coping with every-day life stresses were obtained from 29 migraine patients. Four issues were investigated: (1) the relation between daily stresses and the occurrence of migraine attacks; (2) the associations between ways of stress-coping and attack occurrence; (3) the effects on stress-coping of two behavior therapeutic methods, relaxation training and stress-coping training; (4) the clinical utility of pre-training measurement of stress-coping. the results yield evidence that both threat as a form of every-day stress and 'depressive reaction' as a way to cope with threat are significantly related to the occurrence of migraine attacks. In general the effects of training on stress-coping appeared to be rather small. Three coping strategies changed as a result of both regimens taken together: 'tackling the problem actively' increased, while 'avoidance' and (quite tenuous) 'depressive reaction' decreased. Although relaxation training contributed most to these outcomes, no significant between-group differences were found. Divergent baseline per-subject patterns of stress-coping suggest that individual differences must be acknowledged. A sensible clinical usage of stress-coping data in our view requires that inferences are based on individual rather than group outcomes. Also, one cannot afford to neglect the actual and often idiosyncratic context of stress-coping.