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

Plain English summary of protocol

Background and study aims
Pain and sleep share a complex bidirectional relationship. In both laboratory and clinical settings, pain demonstrates circadian rhythmicity and sensitivity to sleep deprivation. Poor sleep aggravates pain, and increasing pain worsens sleep disturbance, creating a potentially self-perpetuating cycle that may contribute to the development and maintenance of chronic pain. However, the mechanisms by which sleep
deprivation increases pain remain unclear, particularly in the context of fibromyalgia.One proposed mechanism involves kinesiophobia (fear of movement), which is central to the Fear Avoidance Model of chronic pain. This model proposes that excessive fear of movement, due to the expectation that moving will cause pain, prevents people from engaging in beneficial physical activities. This avoidance leads to physical deconditioning, which further amplifies pain by reducing the engagement of endogenous descending pain control mechanisms. Understanding the mechanistic link between sleep, pain, and physical activity
is particularly important in fibromyalgia, a debilitating chronic pain condition characterised by widespread pain, poor sleep, fatigue, and reduced motivation. Polysomnography studies in fibromyalgia have demonstrated specific EEG correlates of sleep fragmentation, including alpha intrusion into slow-wave sleep, which may reflect non-restorative sleep. Observational and laboratory studies have shown behavioural changes consistent with kinesiophobia in this population. Previous research by our group has found that 73% of fibromyalgia patients fulfil criteria for clinical insomnia, with strong correlations between sleep disturbance and pain severity, fear of movement, and quality of life measures. Additionally, patient partners have explicitly identified poor sleep as a barrier to participating in physical rehabilitation and regular exercise, both of which are mainstays of fibromyalgia treatment.

Who can participate?
Adults (aged 18 years or above) with a clinical diagnosis of fibromyalgia or chronic widespread pain who willing and able to provide informed consent for participation in the study, have concomitant insomnia, frequent night-time waking, or early morning waking and reliable internet access (required to access digital intervention).

What does the study involve?
If a participant consents to take part, they will be quired to attend two research visits, 12 weeks apart, lasting approximately two hours. They will undertake a number of assessments:
1. Questionnaires: they will be asked to complete a series of questionnaires prior to attending the research visit, which will focus on their pain experiences, and how it affects their mood, sleep and physical activity. The questionnaires can be completed securely online from any computer. They should take around 30 minutes to complete.
2. Quantitative sensory testing: at the research visit, the participant will undergo sensory testing on the skin of the back of the hand. This is a standard research method used to measure people’s ability to detect a number of different sensory inputs such as touch, pain and pressure triggers. The participant will always be able stop the testing at any point. This should take around 10 minutes to complete.
3. Movement analysis: the participant will be videoed whilst performing three repetitions of some basic physio-type exercises (whilst holding onto a chair for support: marching on the spot holding, mini-squats, bending forwards). This will take a few minutes. The video images will not be stored but transposed by specialist software to “stick man” figures from which joint angles can be calculated.
4. Virtual reality task: the participant will wear a virtual reality (VR) device (headset) and play a game developed by our research team. They will collect specific items to get points in a realistic environment, for example, collecting pineapples at varying heights in a virtual rainforest: the fruits win game points, and the objective is to maximise points. The entire game will be divided into small trials, and at the end of each trial, they will be asked to rate the intensity of the pain and fatigue they just experienced in the past trial. The part of the research visit is expected to be completed in 60 minutes.
To better understand responses to different types of pain, the participant will randomly receive an uncomfortable, mild electrical stimulus via an electrode attached to the finger whilst bending down to pick up certain pineapples. The stimulus feels a bit like a brief pin-prick sensation, which lasts for less than a second, and is mildly uncomfortable, but totally safe. It will be calibrated to the individual’s pain tolerance in a step-wise, increasing fashion and asking the participant to rate the pain felt. If at any point the participant feels the stimuli are too much then this part of the task will be stopped.

Home procedures:
5i. Sleep measurement: the participant will be asked to wear a forehead device (Somnomedic HST REM+) to record brain waves during sleep at home for a minimum of four nights.
5ii. Under-mattress sleep sensor: (Withings Sleep Analyser) will be used for the duration of the study. Once the device is set up via temporary use of a mobile phone app, the sensor will record sleep, breathing rate, heart rate, and snoring whenever the participant is lying on their bed.
6. Actigraphy device: the participant will be asked to wear a specialised watch (MotionWatch 8, CamNTech Ltd.), on their wrist for 7 days, 24 hours a day starting only after the baseline research visit. An actigraphy watch is a device similar to a Fitbit that measures movement, that allows estimation of sleep-wake and activity patterns. This should only be removed for showering, bathing, washing up, or water sport activities. This can be worn in combination with an existing watch or fitness tracker and should be worn on the non-dominant wrist or up on non-dominant arm when working in a role where the arm has to be bare below the elbow.
7. Online sleep intervention (Sleepio): Participants will be randomly allocate to either standard treatment of written materials produced by the charity Versus Arthritis, with evidence-based sleep hygiene advice alone, or this alongside Sleepio. Sleepio is an online program designed by sleep experts based on cognitive behavioural therapy. The program involves 6 personalised 20-minute sessions over 6 weeks. A period of sleep restriction is often recommended, which can temporarily increase daytime sleepiness. Access to Sleepio will be given free of charge, which can be used on a variety of electronic devices including as a mobile phone app or on a computer. Those allocated to Sleepio with receive a telephone check in at a mutually convenient time in weeks 1, 3 and 6.

What are the possible benefits and risks of participating?
The participant will not directly benefit from taking part in this study, but it is hoped that the information gained from this study will help to improve the treatment of sleep for those with fibromyalgia in the future.

The risks of taking part include:
The questionnaires, which ask about sensitive topics such as mood. Participants are under no obligation to answer these questions if they feel too uncomfortable to do so.
The sensory testing may cause minor, temporary discomfort but the participant will be in control of the triggers applied and free to stop the assessment at any point in time.
The VR device is a commonly seen consumer product and can be purchased in the UK. Generally, people are comfortable using this device. Some people experience motion sickness (dizziness and nausea) in VR.
The electrical pain stimulator used during the VR task is guaranteed to be safe by its circuitry design and has been approved for clinical research use. It will be calibrated to the individual’s pain tolerance, with the minimal intensity necessary to achieve goals of the research. Sometimes the electrodes can leave a small mark on the skin but this is temporary. The participant will be able to terminate a painful stimulus at will.
Occasionally, some people may become sensitive to the electrodes used for the sleep monitoring recordings. Sensitivity can include red marks on the skin, raised areas, or sores. The participant will be asked to stop wearing the device if sensitivity occurs.
Wearing the activity watch may cause minor skin irritation but the participant can choose not to wear it if this occurs.
One component of the Sleepio program is an intervention called ‘sleep restriction’. Sleep restriction increases sleep quality by reducing time in bed to the amount of time spent asleep. Sleep restriction may exacerbate sleepiness during the early stages of Sleepio. If the participant does feel sleepy during the study, it is advised to avoid activities that require a high degree of vigilance, such as driving long distance driving or operating heavy machinery. If sleepiness continues after several weeks, this may be a sign of another sleep disorder or medical condition.

Where is the study run from?
The study is being conducted from an Oxford University research facility at the Institute of Biomedical Engineering (UK)

When is the study starting and how long is it expected to run for?
The study started in April 2025 and will end in December 2027.

Who is funding the study?
The Medical Research Council is funding the study.

Who is the main contact?
Amanda Wall, amanda.wall@ndcn.ox.ac.uk

Contact information

Prof Ben Seymour
Principal investigator, Public, Scientific

Nuffiled Department of Clinical Neurosciences
Level 6, West Wing
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

ORCID ID	0000-0003-1724-5832
Phone	+44 7932655415
Email	amanda.wall@ndcn.ox.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centre

Results and Publications

Editorial Notes

09/03/2026: Trial's existence confirmed by NHS HRA.