The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia
Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
University of Oxford
142 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to learn if a digital sleep therapy program (digital Cognitive Behavioural Therapy for Insomnia or dCBT-I) works to improve quality of life and movement in adults with fibromyalgia who also have trouble sleeping. The main questions it aims to answer are: * Does digital sleep therapy improve quality of life for people with fibromyalgia? * Does digital sleep therapy improve sleep quality? * Does better sleep help reduce fear of movement and increase physical activity, assessed in a virtual reality (VR) environment? Researchers will compare digital sleep therapy (called 'Sleepio') to standard care with sleep advice materials. Participants will: * Use the Sleepio program at home for 10 weeks (6 sessions, 20 minutes each) * Wear a sleep monitoring device at home in bed for several nights at the start and after 3 months * Wear an activity watch for 1 week to track movement at the start and after 3 months * Complete questionnaires about pain, sleep, mood, and daily activities at the start, 3 months, and 6 months * Visit the study centre twice for assessments that include: * Pain sensitivity testing * A virtual reality game that measures how they move and make decisions * Recording of simple exercises like marching and squats Participation in the study lasts about 6 months.
Eligibility
Inclusion Criteria6
- Willing and able to provide informed consent for participation in the study
- Male or female, aged 18 years or above
- Clinical diagnosis of fibromyalgia or chronic widespread pain
- Concomitant insomnia, frequent nighttime waking, or early morning waking
- Self-reported difficulties with concentration or memory
- Reliable internet access (required to access digital intervention)
Exclusion Criteria11
- Poor understanding of English
- Known neurological conditions (other than depression or anxiety) likely to independently affect pain assessment results (e.g., peripheral diabetic neuropathy)
- Major neuropsychiatric disorder (bipolar disorder, schizophrenia, or psychotic spectrum disorders)
- Epilepsy
- Cognitive impairment, dementia, or neurodegenerative disorder
- Recent surgery (within past 3 months) or planned surgery during study period
- Current night-time shift work or planned night-time shift work during study period
- Diagnosed sleep disorders including sleep apnea, restless leg syndrome, circadian rhythm disorder, or parasomnia
- Taking prescribed sleep medications on more than 2 nights in the past 2 weeks
- Currently receiving other psychological therapy for insomnia
- Pregnant or lactating
Interventions
Sleepio is a digital cognitive behavioural therapy for insomnia program consisting of 6 automated sessions delivered over 10 weeks (approximately 20 minutes per session). The program features an animated virtual professor and includes evidence-based cognitive and behavioral interventions, sleep hygiene education, sleep restriction therapy, stimulus control, cognitive restructuring, and relaxation techniques. Participants access the program via web browser or smartphone app at their convenience. The program includes a daily sleep diary, access to an online community, and a library of resources. Adherence is supported through automated text reminders via REDCap and telephone/video check-ins with research staff at weeks 1, 3, and 6 of the intervention period.
Written educational materials produced by Versus Arthritis charity providing evidence-based advice on sleep hygiene for people with fibromyalgia. Materials include information booklets and links to video resources covering sleep management strategies, understanding the relationship between sleep and pain, and practical tips for improving sleep quality.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07465991