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New treatment option for Fibromyalgia
Official title The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia
ClinicalTrials.gov ID: NCT07465991
What this study is testing
- What it's testing
- 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?
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Poor understanding of English
- Known neurological conditions (other than depression or anxiety) likely to independently affect pain assessment results (e.g., peripheral diabetic...
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.