The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia
RecruitingNot applicableNCT07465991
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
- Conditions
- Interventions
- Behavioral: Digital Cognitive Behavioural Therapy for Insomnia
- Behavioral: Sleep Hygiene Education Materials
- Sponsor
- University of Oxford
- Collaborators
- Oxford University Hospitals NHS Trust
- Start date
- 2026-01-01
- Primary completion
- 2027-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07465991