Digital cognitive behavioural therapy for insomnia in fibromyalgia: a randomised trial assessing efficacy and exploring mechanisms
Fibromyalgia/chronic widespread pain
Participants will be randomised 1:1 to either Sleepio or standard care after a 4-week run-in period. Intervention: The digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) program Sleepio consists 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. Control: Sleep hygiene education materials. 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.
1. Clinical diagnosis of fibromyalgia/chronic widespread pain 2. Concomitant insomnia, frequent waking in the night or early morning waking 3. Reliable internet access
1. Poor understanding of English 2. Known neurological conditions (other than depression or anxiety) likely to independently affect pain assessment results (for example, peripheral diabetic neuropathy) 3. Major neuropsychiatric disorder (bipolar disorder, schizophrenia, or psychotic spectrum disorders) 4. Epilepsy 5. Cognitive impairment, dementia, or neurodegenerative disorder 6. Recent surgery within past 3 months or planned surgery during study period 7. Current night-time shift work or planned night-time shift work during study period 8. Diagnosed sleep disorders including sleep apnea, restless leg syndrome, circadian rhythm disorder, or parasomnia 9. Taking prescribed sleep medications on more than 2 nights in the past 2 weeks 10. Currently receiving other psychological therapy for insomnia 11. Pregnant or lactating