Migraine is a common neurological problem associated with the highest burden amongst neurological conditions in terms of years lived with disability. Medications can be used as prophylaxis or rescue medicines, but are costly and not always effective. A range of psychological interventions have been developed to manage migraine.
The objective was to evaluate the efficacy and adverse events of psychological therapies for the prevention of migraine in adults.
We searched CENTRAL, MEDLINE, Embase, PsycINFO and CINAHL from their inception until July 2018, and trials registries in the UK, USA, Australia and New Zealand for randomised controlled trials of any psychological intervention for adults with migraine.
We included randomised controlled trials (RCTs) of a psychological therapy for people with chronic or episodic migraine, with or without aura. Interventions could be compared to another active treatment (psychological or medical), an attention‐placebo (e.g. supportive counselling) or other placebo, routine care, or waiting‐list control. We excluded studies where fewer than 15 participants completed each arm.
Data collection and analysis
We extracted study characteristics and outcome data at post‐treatment and the longest available follow‐up. We analysed intervention versus control comparisons for the primary outcome of migraine frequency. We measured migraine frequency using days with migraines or number of migraine attacks measured in the four weeks after treatment. In addition, we analysed the following secondary outcomes: responder rate (the proportion of participants with a 50% reduction in migraine frequency between the four weeks prior to and the four weeks after treatment); migraine intensity; migraine duration; migraine medication usage; mood; quality of life; migraine‐related disability; and proportion of participants reporting adverse events during the treatment. We included these variables, where available, at follow‐up, the timing of which varied between the studies. We used the GRADE approach to judge the quality of the evidence.
We found 21 RCTs including 2482 participants with migraine, and we extracted meta‐analytic data from 14 of these studies. The majority of studies recruited participants through advertisements, included participants with migraine according to the International Classification of Headache Disorders (ICHD) criteria and those with and without aura. Most intervention arms were a form of behavioural or cognitive‐behavioural therapy. The majority of comparator arms were no treatment, routine care or waiting list. Interventions varied from one 20‐minute session to 14 hours of intervention. No study had unequivocally low risk of bias; all had at least one domain at high risk of bias, and 20 had two to five domains at high risk. Reporting of randomisation procedures and allocation concealment were at high or unclear risk of bias. We downgraded the quality of evidence for outcomes to very low, due to very serious limitations in study quality and imprecision. Reporting in trials was poor; we found no preregistrations stipulating the outcomes, or demonstrating equivalent expectations between groups. Few studies reported our outcomes of interest, most only reported outcomes post treatment; follow‐up data were sparse.
We found no evidence of an effect of psychological interventions for migraine frequency in number of migraines or days with migraine (standardised mean difference (SMD) −0.02, 95% confidence interval (CI) −0.17 to 0.13; 4 studies, 681 participants; very low‐quality evidence).
The responder rate (proportion of participants with migraine frequency reduction of more than 50%) was greater for those who received a psychological intervention compared to control: 101/186 participants (54%) with psychological therapy; 37/152 participants (24%) with control (risk ratio (RR) 2.21, 95% CI 1.63 to 2.98; 4 studies, 338 participants; very low‐quality evidence). We found no effect of psychological therapies on migraine intensity (SMD −0.13, 95% CI −0.28 to 0.02; 4 studies, 685 participants). There were no data for migraine duration (hours of migraine per day). There was no effect on migraine medication usage (SMD −0.06, 95% CI −0.35 to 0.24; 2 studies, 483 participants), mood (mean difference (MD) 0.08, 95% CI −0.33 to 0.49; 4 studies, 432 participants), quality of life (SMD −0.02, 95% CI −0.30 to 0.26; 4 studies, 565 participants), or migraine‐related disability (SMD −0.67, 95% CI −1.34 to 0.00; 6 studies, 952 participants). The proportion of participants reporting adverse events did not differ between those receiving psychological treatment (9/107; 8%) and control (30/101; 30%) (RR 0.16, 95% CI 0.00 to 7.85; 2 studies, 208 participants). Only two studies reported adverse events and so we were unable to draw any conclusions.
We rated evidence from all studies as very low quality.
Only four studies reported any follow‐up data. Follow‐ups ranged from four months following intervention to 11 months following intervention. There was no evidence of an effect on any outcomes at follow‐up (very low‐quality evidence).
This review identified 21 studies of psychological interventions for the management of migraine. We did not find evidence that psychological interventions affected migraine frequency, a result based on four studies of primarily brief treatments. Those who received psychological interventions were twice as likely to be classified as responders in the short term, but this was based on very low‐quality evidence and there was no evidence of an effect of psychological intervention compared to control at follow‐up. There was no evidence of an effect of psychological interventions on medication usage, mood, migraine‐related disability or quality of life. There was no evidence of an effect of psychological interventions on migraine frequency in the short‐term or long‐term. In terms of adverse events, we were unable to draw conclusions as there was insufficient evidence. High and unclear risk of bias in study design and reporting, small numbers of participants, performance and detection bias meant that we rated all evidence as very low quality. Therefore, we conclude that there is an absence of high‐quality evidence to determine whether psychological interventions are effective in managing migraine in adults and we are uncertain whether there is any difference between psychological therapies and controls.
Plain language summary
Psychological therapies for the management of migraine in adults
There was an absence of good‐quality evidence that psychological therapy was effective or harmful in managing frequent migraine immediately following treatment or in the longer term.
Migraine is a condition of the nervous system that is common and associated with lower quality of life and disability. Although medications can help manage migraine, they do not work for all individuals and some individuals experience negative side‐effects (adverse events). Numerous psychological therapies have been evaluated for the management of migraine in adults. Psychological therapies deliver skills such as education, relaxation, or coping strategies to help adults change their behaviour or thoughts about migraine, to try to reduce their migraine‐related symptoms.
We evaluated psychological interventions for adults with chronic or episodic migraine with and without aura (a warning sign that precedes and predicts a migraine). We compared individuals who received psychological therapy for migraine with a ‘control’ group. Control groups included usual treatment (‘standard care’), or waiting to receive treatment, or receiving another type of intervention such as education. We extracted data on the frequency of migraines (i.e. number of days with migraines, or number of migraines, in the month following treatment) as our primary outcome. We also extracted data on the number of responders (people with a 50% reduction in migraine frequency), migraine intensity, migraine duration (number of hours of migraine per day), migraine medication usage, mood, quality of life, and migraine‐related disability. We recorded instances of harm (adverse events) associated with treatment.
We searched databases in July 2018 and found 21 studies with 2482 participants. Most studies investigated one of three interventions, namely a form of psychological therapy called cognitive‐behaviour therapy (CBT), which teaches skills to change thoughts and behaviours. Skills include coping strategies, or biofeedback or relaxation, which teaches people to reduce their tension either by concentrating on relaxing exercises or through a machine that gives feedback about muscle tension or body temperature. The remaining psychological treatments were examined in single studies; they included writing about emotions and eye movement desensitisation, and reprocessing, which uses eye movements to help people accept their pain and other negative experiences. We were interested in outcomes following treatment and at the longest available follow‐up.
We found no evidence that psychological treatments resulted in less migraine frequency in the four weeks following treatment. However, we could only include four studies in this analysis that were not high quality. Four studies reported the proportion of people whose migraines reduced in frequency by 50% or more, and in those studies, people who received psychological treatment were twice as likely to respond to treatment (i.e. 50% reduction in migraine frequency) as those in the control group.
There was no evidence that psychological treatments affected migraine intensity, medication use for migraine, mood or quality of life. Only two studies assessed adverse events, and so we were unable to draw conclusions.
We found very few follow‐up data, and no evidence to support or refute any long‐term effects of psychological treatment.
Quality of evidence
We rated the quality of the evidence using four levels: very low, low, moderate, or high. High‐quality evidence means that we are very confident in the results. Very low‐quality evidence means that we are very uncertain about the results. We judged the quality of evidence as very low.
There is no evidence that psychological treatments affect the frequency of migraine. More responders (i.e. those reporting a 50% reduction) received psychological treatment than control, but this was based on very low‐quality evidence and therefore we are uncertain of this result. In terms of adverse events, we were unable to draw conclusions as there was insufficient evidence. There were very few long‐term data available, and no indication that psychological interventions had any long‐term effects. Overall there was an absence of high‐quality evidence for the effect of psychological treatment on migraines and therefore we are uncertain whether there is any difference between psychological therapies and controls. Funding of high‐quality studies is needed and additional studies may change the conclusions of this review.