Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS).

Introduction: Chronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.
Methods and Analysis: Chronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.
Ethics and Dissemination: This trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West - Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.
Trial Registration Number: ISRCTN79708100.
Competing Interests: Competing interests: MU is a director and shareholder of Clinvivo Ltd. Use of this company was specified in original application for funding to NIHR. MU has recused himself from all discussion regarding the use of the app in this study. All contracting processes have been in accord with University of Warwick financial regulations. MU was chair of the National Institute for Health and Care Excellence accreditation advisory committee until March 2017 for which he received a fee. He is chief investigator or coinvestigator on multiple previous and current research grants from the UK NIHR, Arthritis Research UK and is a coinvestigator on grants funded by Arthritis Australia and Australian NHMRC. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is part of an academic partnership with Serco Ltd related to return to work initiatives. He is an editor of the NIHR journal series and a member of the NIHR Journal Editors group for which he receives a fee. He has published multiple papers on chronic pain some of which are referenced in this paper. MM serves on the advisory board for Allergan, Medtronic, Novartis and TEVA and has received payment for the development of educational presentations from Allergan, electroCore, Medtronic, Novartis and TEVA. ShP and HKS are directors of Health Psychology Services Ltd, which in part provides psychological treatments for those with chronic pain.
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