NCT07465991 The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia
| NCT ID | NCT07465991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2026-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Ben Seymour, PhD
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT07465991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07465991 currently recruiting?
Yes, NCT07465991 is actively recruiting participants. Contact the research team at amanda.wall@ndcn.ox.ac.uk for enrollment information.
Where is the NCT07465991 trial being conducted?
This trial is being conducted at Oxford, United Kingdom, Oxford, United Kingdom.
Who is sponsoring the NCT07465991 clinical trial?
NCT07465991 is sponsored by University of Oxford. The principal investigator is Ben Seymour, PhD at University of Oxford. The trial plans to enroll 142 participants.
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