The effect of digital cognitive behavioural therapy for insomnia on physical activity in fibromyalgia

This study is looking for adults aged 18 or older who have been diagnosed with fibromyalgia or long-lasting widespread pain. It's important that you also experience difficulties with sleep, such as insomnia, waking up often during the night, or waking up too early. You'll also need to have reliable internet access to take part in the study.

There are some reasons why you might not be able to join. For example, if you have certain other neurological conditions (apart from anxiety or depression) or a major mental health condition like bipolar disorder or schizophrenia. You also can't take part if you have epilepsy or problems with your memory or thinking. If you've had recent surgery, have surgery planned during the study, or work night shifts, you won't be able to join. The study also can't include people who have other diagnosed sleep disorders like sleep apnea, use sleep medication very often, or are already getting other therapy for their insomnia. Lastly, if you are pregnant or breastfeeding, you won't be able to participate.

If you decide to take part, you'll have two in-person visits at the research centre in Oxford, 12 weeks apart, each lasting about two hours. Before these visits, you'll complete some online questionnaires about your pain, mood, sleep, and physical activity, which should take about 30 minutes.

During your visits, you'll have some tests done. This includes 'sensory testing' on your hand to see how you react to different touches or pressures (about 10 minutes). You'll also be videoed doing a few simple exercises like marching or mini-squats, but the videos are only used to create 'stick-man' figures for analysis, not stored as actual footage. You'll also wear a virtual reality (VR) headset to play a game for about an hour, rating your pain and tiredness during it. During this game, you might feel a mild, brief electrical tingle on your finger, which is harmless and will be adjusted to your comfort level.

At home, you'll wear a small device on your forehead for at least four nights to record your brain activity during sleep. You'll also use a sensor placed under your mattress for the whole study to track your sleep, breathing, and heart rate. Additionally, you'll wear a special watch, similar to a Fitbit, on your wrist for 7 days, 24 hours a day (except when showering or swimming) to measure your movement and sleep patterns. When it comes to the main part of the study, you'll be randomly put into one of two groups: either you'll receive standard written information about good sleep habits, or you'll get access to the Sleepio online programme, which involves 6 personalised sessions over 6 weeks. If you're in the Sleepio group, you'll also have telephone check-ins.