Chronic Headache Education and Self-management Study (CHESS) – a study of the clinical and cost effectiveness of an education and self-management intervention for people with chronic headache
Chronic headaches
Feasibility study: An education and self-management support intervention for the management of chronic headaches, specifically, migraine, TTH and MOH will be designed and evaluated. The design of the intervention will be informed by systematic reviews on the lived experience of chronic headache, prognostic factors for people living with chronic headache, and style and content of intervention programmes. Randomised controlled trial: Participants will be randomised to either the relaxation group or self-management group and will receive written notification of the randomisation outcome. The same information will also be sent to the participant’s GP to notify them of randomisation into the study and a copy of the information provided to the participant for the patient notes. The randomisation will be stratified by geographical locality (Midlands and North-east London) and headache type (six possible headache types; tension type headache, probable chronic migraine and definite chronic migraine with or without medication overuse headache) using randomly permuted blocks, and implemented using a remote, independent telephone randomisation service at Warwick Clinical Trials Unit. Warwick CTU will manage randomisation ensuring allocation concealment. Staff responsible for follow-up data collection will be blinded to randomisation.Groups of 4-5 geographically close practices will be clustered with the aim to launch recruitment at around the same time in the practices. Participants ware then randomised whensufficient participants to populate a group in batches of around 20 participants are enrolled. This will help reduce any delay between randomisation and start of the intervention. Intervention arm: The intervention is a group education and self-management programme (around 10 participants per group) facilitated by a trained CHESS nurse and allied health professional. Those randomised to the intervention arm are asked to complete a paper headache diary for a period of up
1. Able and willing to comply with the study procedures and provision of written informed consent 2. Aged 18 years or above 3. Living with chronic headache; defined as headache for 15 or more days per month for at least three months. 4. Result of nurse classification interview confirms headache type to be definite or probable chronic migraine, or chronic tension type headache, and/or medication overuse headache 5. Fluent in written and spoken English
1. Unable to attend treatment programme 2. No access to a telephone 3. Has an underlying serious psychiatric or psychological disorder that precludes participation in the group intervention 4. Known secondary cause of headache other than medication overuse headache; e.g. primary or secondary brain tumour 5. Is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial