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HomeMental HealthThe Effect of Digital Cognitive Behavioural Therapy for…

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

25 March 2026 Read original ↗
🅇 This trial is currently recruiting participants in the UK
Speak to your GP or specialist first. They can help you understand if you might be eligible and what taking part would involve.
🅇 This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
NA
Participants
ALL
Age Range
18 Years+

About This Trial

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.

Who Can Join?

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…

⚠ Always speak to your doctor before applying to any clinical trial.

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