FibromyalgiaPain-LESSNCT05962138
A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia
A study testing Digital Cognitive Behavioural Therapy for Insomnia in people with Fibromyalgia, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Digital Cognitive Behavioural Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 31 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
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:
Read more
- 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.
Read the detailed description
Fibromyalgia patients commonly experience cognitive issues such as concentration and memory difficulties and sleep disorders. Despite the prevalence of these symptoms, no established treatments currently exist. Traditional in-person Cognitive Behavioural Therapy (CBT), which focuses on modifying unhelpful thoughts and behaviours, is both expensive and challenging to deliver on a broad scale. New digital forms of CBT, specifically for insomnia (CBT-I), have shown promise in improving cognitive symptoms and sleep quality, but their effect on fibromyalgia patients is yet to be explored.
The study will investigate the efficacy of 'Sleepio', an established digital CBT-I (dCBT-I) tool. Sleepio has shown effectiveness in treating insomnia and its cognitive symptoms, offering a promising approach to address similar issues in fibromyalgia. Sleepio's approach involves six 20-minute sessions over 10 weeks with a virtual therapist who employs key cognitive and behavioural strategies to enhance sleep quality.
Participants in this study will be randomised in a 1:1 ratio to either treatment with Sleepio treatment or standard care with standard sleep hygiene advice. The primary outcome is quality of life measured on the Revised Fibromyalgia Impact Questionnaire (FIQR), 12 weeks following randomisation. Secondary outcomes include subjective cognition (British Columbia Cognitive Complaints Inventory, BC-CCI), objective cognitive function (tests of reaction time, working memory, processing speed), quantitative cognitive avoidance testing (QCAT), sleep quality (actigraphy, insomnia severity index (ISI), Pittsburgh Sleep Quality Index (PSQI), pain (NRS), fear of movement (Tampa Scale of Kinesiophobia) and quantitative movement assessment. Assessments will be carried out using online tools.
Additionally, a subset of participants will undergo sleep actigraphy and/or neuroimaging using MRI scans for a more detailed analysis.
Primary Objectives:
- Assess the impact of Sleepio (dCBT-I) on quality of life (FIQR) in fibromyalgia patients.
Secondary Objectives:
- Assess the impact of Sleepio (dCBT-I) on subjective (BC-CCI) and objective cognitive function in fibromyalgia patients.
- Investigate the effect of Sleepio on sleep quality (ISI \& PSQI) in fibromyalgia patients.
- Investigate cost-effectiveness of Sleepio (dCBT-I)
- Does Sleepio improve subjective and objective measures of motor function in fibromyalgia?
As part of the study, participants will also be invited to join a research database for potential inclusion in future studies conducted by the research group.
- Conditions
- Fibromyalgia
- Being tested
- Digital Cognitive Behavioural Therapy for Insomnia
- Keywords
- sleep, digital, cognitive behavioural therapy for insomnia, fibromyalgia, pain, cognition
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioural Therapy for InsomniaBehavioural
Also called Sleepio
6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. In addition participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Sleepio (dCBT-I) | Experimental | 6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.
Participants will also receive a booklet with general advice for patients with fibromyalgia, including sleep hygiene. Receives: Behavioral: Digital Cognitive Behavioural Therapy for Insomnia |
| Treatment as usual | No intervention | Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the 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. Higher scores indicate more severe symptoms.
Measured: 12 weeks
Secondary outcomes (15)
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the 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. Higher scores indicate more severe symptoms.
Measured: 24 weeks
Sleep quality
Changes in sleep pattern on actigraphy between treatment groups
Measured: 12 weeks
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the 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. Higher scores indicate more severe symptoms.
Measured: 52 weeks
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.
Measured: 12 weeks
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.
Measured: 24 weeks
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
The British Columbia Cognitive Complaints Inventory (BC-CCI), range 0-18, is a rapid screening tool that assesses perceived cognitive difficulties. Higher scores indicate more severe symptoms.
Measured: 52 weeks
Change in Tampa Scale of Kinesiophobia (TSK) from baseline
The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.
Measured: 12 weeks
Change in Tampa Scale of Kinesiophobia (TSK) from baseline
The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.
Measured: 24 weeks
Change in Tampa Scale of Kinesiophobia (TSK) from baseline
The Tampa Scale of Kinesiophobia (TSK), range 17-68, is a patient-reported outcome measure designed to quantify kinesiophobia or fear of movement. Higher scores indicate greater fear of movement.
Measured: 52 weeks
Cost-effectiveness of dCBT-I
Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£).
Measured: 12 weeks
Cost-effectiveness of dCBT-I
Health-related quality of life measured with EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) at baseline, 3- and 6-months. Healthcare resource use data collected at 3- and 6-months. This will be evaluated using cost-effectiveness analysis looking at cost per quality adjusted life year (QALY) with the treatment. QALYs will be estimated using EQ-5D-3L, with higher values indicating better health outcomes. The EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health. QALYs will be calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale) from the EQ-5D-3L. Healthcare resource use will be evaluated in the local currency (£).
Measured: 24 weeks
Changes in brain structure
Change in brain grey matter volume on structural MRI
Measured: 12 weeks
Changes in brain functional connectivity
Changes in brain resting state functional connectivity on resting-state functional MRI
Measured: 12 weeks
Changes in neurotransmitter concentration in the insular
Changes in neurotransmitter concentration in the insular on magnetic resonance spectroscopy
Measured: 12 weeks
Changes in brain function
Changes in brain resting state activity on arterial spin labelling (ASL) on brain MRI
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jun 2023
- Primary completion28 Feb 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled trial with two parallel study arms: (1) digital cognitive behavioural therapy for insomnia (experimental condition), and (2) treatment as usual (control condition). Randomisation will be using a 1:1 ratio (experimental:control), within minimisation of between group differences in sex, and inclusion status in imaging sub-study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Big Health Ltd.
- Responsible party
- Sponsor
- Investigators
- Anushka Soni, Dr, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962138
- Sponsor's protocol ID
- 252762
- Acronym
- Pain-LESS
- Status last verified
- May 2026
- First submitted
- 26 Jun 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data are available upon reasonable request