Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia: A Randomised Trial Assessing Efficacy and Exploring Mechanisms

Fibromyalgia is one of the most debilitating and poorly understood causes of chronic pain, affecting up to one-in-twenty British adults. It involves disabling symptoms including persistent widespread pain, poor sleep, fatigue, and low mood, leading to significant disability and reduced quality-of-life. This places significant costs on the healthcare system and society as up to one-in-four people with fibromyalgia cannot work. The current mainstay of treatment is a combination of physiotherapy and psychological therapy, however sleep disturbance is often neglected. This is an important gap, as poor sleep may aggravate fear of movement and affect patients' abilities to engage with physical activity which is known to be beneficial in the disorder. Preliminary evidence in fibromyalgia, as well as other chronic pain conditions, supports targeting sleep alongside pain. Recently, the James Lind alliance, a priority-setting partnership which brings together patients and clinicians, alongside recent recommendations by the National Institute for Health and Care Excellence (NICE), have highlighted the study of sleep therapies in chronic pain as a priority for research. Previous studies have shown that sleep therapy may improve sleep and pain in chronic pain conditions like fibromyalgia, but we do not know if it improves quality-of-life. Moreover, we do not know how sleep therapy works in chronic pain. This project has two aims. The first is to test if improving sleep can improve quality-of-life, and so offer a significant improvement on current fibromyalgia treatment. The second is to understand through which mechanisms sleep therapy affects pain, movement, and quality-of-life in fibromyalgia. A better understanding of the underlying mechanisms linking sleep, pain, and movement may enable us to refine and tailor sleep therapies for patients with chronic pain conditions like fibromyalgia. This project has been co-designed with patients with fibromyalgia, and we will perform a randomised controlled trial of an online cognitive behavioural therapy program for insomnia (CBTi) in 142 fibromyalgia patients in Oxfordshire. We will use a program called 'Sleepio', which is a NICE-recommended form of digital CBTi developed by colleagues at Oxford. This can be performed by patients at home without requiring the presence of a therapist. We will monitor sleep and movement over a 12-week period in patients randomised to either CBTi or conventional care. We will monitor sleep using easy to use home-based devices which measure brain activity (EEG) and physical activity (actigraphy). We will measure movement using at-home video analysis of physiotherapy exercises, and lab-based virtual reality movement tasks. Our project team brings together core expertise in sleep and the management of insomnia; and in the clinical neuroscience of chronic pain. We have substantial experience in clinical trials, technology development and testing, basic and clinical neuroscience, and working with patient partners and other stakeholders. If successful, the project could greatly improve how fibromyalgia is managed in the NHS, helping to refine sleep therapy for chronic pain conditions. This could be particularly beneficial for women and underserved groups, such as those from more deprived backgrounds, who are more frequently affected by fibromyalgia. This will help address longstanding inequalities in the delivery of care for pain and sleep problems. Chronic pain is the leading global cause of disability; CBT for both pain and sleep delivered using digital platforms further allows for scalable translation to other chronic pain disorders, as well as application in low- and middle-income settings