Fibromyalgia Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 31/10/2023:
Digital Cognitive Behavioural Therapy for Insomnia
6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. In addition, pa
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 31/10/2023: 1. Participant is willing and able to give informed consent for participation in the study. 2. Clinical diagnosis of fibromyalgia/chronic widespread pain 3. For feasibility study 3.1. Concomitant insomnia, frequent waking in the night or early morning waking 3.2. Self-reported difficulties with concentration or memory 3.3. Reliable Internet access Previous participant inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Clinical diagnosis of either inflammatory arthritis or fibromyalgia/chronic widespread pain
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 31/10/2023: 1. Patients from vulnerable groups 2. Patients with a poor understanding of English 3. 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. 4. For feasibility study 4.1. Major neuropsychiatric disorder (bipolar disorder, schizophrenia or psychotic spectrum disorders), however, participants with depression and anxiety will be eligible 4.2. Epilepsy 4.3. Cognitive impairment, dementia or neurodegenerative disorder 4.4. Recent or planned surgery 4.5. Current or planned night-time shift work 4.6. Sleep disorders such as sleep apnoea, restless leg syndrome, circadian rhythm disorder, or parasomnia 4.7. Taking prescribed sleep medications on more than 2 nights in past 2 weeks 4.8. Currently receiving other psychological therapy for insomnia 4.9. Pregnant or lactating Previous participant exclusion criteria: 1. Patients from vulnerable groups 2. Patients with a poor understanding of English 3. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 01/11/2023: Overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems, measured using the Revised Fibromyalgia Impact Questionnaire (FIQR) at baseline and 12, 24 and 52 weeks Previous primary outcome measure: Percentage achieving Disease Activity Score <2.6, assessed using a combination of the patient report and clinical assessment, 3 and 6 months after commencing treatment respectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 01/11/2023: 1. Cognitive difficulty, measured using the British Columbia Cognitive Complaints Inventory, at baseline and 12, 24 and 52 weeks 2. Kinesiophobia, measured using the Tampa Scale of Kinesiophobia, at baseline and 12, 24 and 52 weeks 3. Cost-effectiveness of Sleepio, measured using the EQ-5D-5L, at baseline and 12 and 24 weeks 4. Sleep quality, measured using actigraphy, at baseline and 12 weeks 5. Changes in brain structure, measured using brain grey matter volume on structural MRI, at baseline and 12 weeks 6. Changes in brain functional connectivity, measured using brain resting state functional connectivity on resting-state functional MRI, at baseline and 12 weeks 7. Changes in neurotransmitter concentration in the insular, measured using neurotransmitter concentration in the insular on magnetic resonance spectroscopy, at baseline and 12 weeks 8. Changes in brain function, measured using brain resting state activity on arterial spin labelling (ASL) on brain MRI, at baseline and 12 weeks Previous secondary outcome measure: Scoring according to: Central Sensitivity Inventory, Fibromyalgia survey criteria, PainDETECT questionnaire alongside neuroimaging findings, collected over a 12-month period. | — |
Countries
England, United Kingdom
Contacts
Public ContactAnushka Soni
Outcome results
None listed