RecruitingNAINTERVENTIONAL

The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia

This study aims to understand if a digital sleep therapy programme, specifically for insomnia, can improve the quality of life and physical activity levels of adults with fibromyalgia. Fibromyalgia often causes widespread pain, poor sleep, and fatigue, making it hard for people to move. Researchers want to see if better sleep can reduce the fear of movement and encourage more physical activity. They will compare a digital sleep programme called 'Sleepio' with general sleep education materials. Participants will use the programme or receive materials, wear devices to track sleep and activity, and complete questionnaires over about 6 months.

At a glance

Status

Recruiting

Phase

Sponsor

University of Oxford

Enrolment target

142

Start

01 Jan 2026

Estimated completion

31 Dec 2027

Fibromyalgia

What is this study about?

This study is investigating a link that many people with fibromyalgia know all too well: the connection between pain and sleep. It often feels like poor sleep makes pain worse, and increased pain makes it harder to sleep, creating a difficult cycle to break. This research is trying to figure out if improving sleep could be a key to helping people with fibromyalgia feel better overall. One of the main ideas behind this study is that when people are in pain, they might become afraid to move, fearing that activity will make their pain worse. This fear can lead to them moving less, which can then make their bodies weaker and potentially increase their pain even more. The study wants to see if better sleep might help to lessen this fear of movement, encouraging people to be more active. If people become more active, it could improve their general well-being and quality of life. The researchers are specifically looking at a digital programme called 'Sleepio', which is a type of Cognitive Behavioural Therapy designed for insomnia (dCBT-I). They are comparing this digital approach to simply providing educational materials about good sleep habits. By taking part, people could help us understand if a digital sleep programme can significantly improve symptoms like pain, fear of movement, and overall quality of life for those living with fibromyalgia.

Key takeaways

This study explores if a digital sleep program helps people with fibromyalgia.
It aims to improve sleep, reduce pain, and encourage more physical activity.
Participants will use a digital program or receive sleep advice for about 6 months.
Involves tracking sleep/activity at home and two visits for assessments.
You can stop participating at any time without affecting your healthcare.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over. You should have a diagnosis of fibromyalgia or chronic widespread pain and also experience problems sleeping, such as difficulty falling asleep, waking up frequently, or waking too early. You also need to have reliable internet access to use the digital programme. There are some reasons why you might not be able to join. For example, if you have certain neurological conditions (like advanced diabetes nerve damage) or major mental health conditions like bipolar disorder, or epilepsy. You also can't participate if you've had recent surgery or have one planned during the study, or if you work night shifts. If you have been diagnosed with other sleep disorders like sleep apnoea or restless leg syndrome, or if you're taking prescribed sleep medication frequently, you won't be able to join this study. Finally, you'll need to understand English well enough to follow the study instructions and materials. If you are pregnant or breastfeeding, you also wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of fibromyalgia or chronic widespread pain?
Do you have trouble sleeping (insomnia or frequent waking)?
Do you have reliable internet access at home?
Do you understand English well enough to follow instructions?
Are you *not* pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would last for about 6 months. Here's a rundown of what that would involve: You'd start by either using the 'Sleepio' digital programme at home for 10 weeks, which includes 6 sessions, each lasting about 20 minutes, or you'd receive standard sleep advice materials. You'll need to wear a small device in bed to monitor your sleep for a few nights at the very beginning of the study and again after 3 months. You'll also wear a special watch for one week to track your movement and activity, both at the start and after 3 months. Throughout the study, you'll fill out questionnaires about how you're feeling, including your pain, sleep, mood, and daily activities, at the beginning, after 3 months, and again after 6 months. There will be two visits to a study centre. During these visits, researchers will assess your pain sensitivity, ask you to participate in a virtual reality game that looks at how you move and make decisions, and record you doing some simple exercises, like marching and squats.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining new tools for managing your sleep through the digital therapy programme or educational materials, which might lead to improved sleep, reduced pain, and increased activity. However, there are no guarantees that you will personally benefit. Potential risks are generally low, mainly involving the time commitment for assessments, wearing monitoring devices, and answering questionnaires. Some people might find talking about their pain or sleep difficulties uncomfortable. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford Centre for Integrative Neuroimaging
Verified postcode
Oxford, United Kingdom· Not yet recruiting
University of Oxford
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is fibromyalgia?

Fibromyalgia is a long-term condition that causes widespread pain all over the body, along with extreme tiredness (fatigue) and problems with memory and concentration.

What is digital Cognitive Behavioural Therapy for Insomnia (dCBT-I)?

It's a digital programme designed to help you change thoughts and behaviours that prevent you from sleeping well, using methods taught in traditional therapy but delivered online.

Will I have to take any new medications for this study?

No, this study does not involve taking new medications. It focuses on a digital sleep programme or sleep education.

How often do I need to attend the study centre?

You will need to visit the study centre twice over the 6-month period for assessments.

What happens if I don't want to continue in the study?

You can withdraw from the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Amanda Wall, BSc MSc

amanda.wall@ndcn.ox.ac.uk +44 1865 611450 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.