Title: Self-management migraine Headache Education (SHE): a pilot trial
Funder: Department of Health (England)

Abstract: Background Migraine headache is common, and causes disability and distress for patients. NHS treatment has focussed on medication. Those whose symptoms continue experience decreased participation in work, family and social life. In a review of the literature from around the world we found short courses of relaxation and cognitive behavioural therapy are effective in reducing the frequency and impact of headaches. These approaches work by helping patients address the triggers for their attacks and manage their condition. No such interventions are, however, available in the U.K. We have developed a short, manualised self-management headache intervention (SHE), delivered by a nurse over 5 weeks. We plan to pilot it in the NHS context comparing SHE (plus standard medical care -SMC) to SMC alone. Aims In line with MRC guidelines (1), a pilot study shall be conducted to address uncertainties that have been identified in the development of SHE and provide design information necessary for a future definitive trial of SHE. The objectives are to: 1. Calculate recruitment, consent and follow-up rates. 2. Test acceptability of randomisation to participants. 3. Describe questionnaire acceptability to participants, and their views of those which represent the most important outcomes. 4. Calculate estimates of the location of the mean and variability around the mean (standard deviation) for the outcome measures. A conservative estimate using the 95% upper confidence limit will be used to inform the sample size calculation of a future RCT. 5. Assess treatment fidelity of SHE. Plan of Investigation We plan to recruit 80 adults with migraine from Headache Clinics in Lambeth and Southwark, run by Practitioners with Special Interest in Headache. They will be fully informed and invited to participate in a randomised trial. At baseline, 5 weeks and 4 months, information will be collected on headache frequency, impact, disability, anxiety and depression, illness beliefs, health locus of control, quality of life and health service costs. We will invite participants to be interviewed after the intervention, to describe their views of it and the importance they attach to the measures in measuring outcome. Participants randomised to the comparison group will continue to receive SMC and will be offered the manual and relaxation computer disc on study completion. Potential Impact We will have information on measures of outcome to estimate how many participants are needed to demonstrate an important change in a particular measure or range of outcomes. We will have qualitative evidence on what participants value in terms of measures of change, and their views of a new approach to self-management education for migraine. Using this evidence we will be able to design a definitive trial. Two user groups have agreed to disseminate the results at meetings, and help us write up and publish our findings in journals targeted at policy makers, service providers and users. If SHE is effective in reducing headache frequency and distress, it will increase capacity for work for people with migraine, and employers, and reduce cost to the health and social services.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: NEUROLOGICAL