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

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 Criteria:

* 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 Criteria:

* 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

Conditions2

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