A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia (NCT05962138) | Clinical Trial Compass
CompletedNot Applicable
A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia
United Kingdom80 participantsStarted 2023-06-01
Plain-language summary
The goal of this clinical trial is to investigate the potential benefits of a digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) platform, Sleepio, in individuals suffering from fibromyalgia, a condition commonly associated with cognitive issues and sleep disorders.
The main questions this study aims to answer are:
* Does the application of Sleepio improve quality of life in individuals with fibromyalgia?
* Does the use of Sleepio improve cognitive function in individuals with fibromyalgia?
* Does the use of Sleepio enhance sleep quality in these same individuals?
* Does the use of Sleepio improve motor function in this group?
Participants will be randomly assigned to either use the Sleepio platform or standardised health advice, including sleep hygiene material. Those assigned to Sleepio will undergo a series of six 20-minute sessions over 10 weeks with a virtual therapist focusing on cognitive and behavioural strategies for improving sleep.
Participants' quality of life, cognitive function, sleep quality, and pain levels will be monitored and evaluated using online assessment tools. Additionally, a subset of participants will undergo further testing via sleep actigraphy and/or neuroimaging with MRI scans.
Researchers will compare the two groups to determine if the use of Sleepio has a positive effect on quality of life, cognitive function, and sleep quality.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of fibromyalgia
* Concomitant insomnia, frequent waking in the night or early morning waking
* Self-reported difficulties with concentration or memory
* Reliable internet access
Exclusion Criteria:
* Patients with a poor understanding of English.
* Patients with known neurological or psychiatric conditions (other than depression or anxiety) likely to independently affect the results of pain assessment, for example peripheral diabetic neuropathy in the opinion of the research team
* Major neuropsychiatric disorder (bipolar disorder, schizophrenia or psychotic spectrum disorders)
* Epilepsy
* Cognitive impairment, dementia or neurodegenerative disorder
* Recent or planned surgery
* Current or planned night-time shift work
* Sleep disorders such as sleep apnoea, restless leg syndrome, circadian rhythm disorder, or parasomnia
* Taking prescribed sleep medications on more than 2 nights in past 2 weeks
* Currently receiving other psychological therapy for insomnia
* Pregnant or lactating
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline