Clinical trial NCT05962138: A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia
Official title: Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: sleep
digital
cognitive behavioural therapy for insomnia
fibromyalgia
pain
cognition
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Big Health Ltd.
First posted: 2023-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
timeFrame: 24 weeks
measure: Sleep quality
timeFrame: 12 weeks
measure: Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
timeFrame: 52 weeks
measure: Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
timeFrame: 12 weeks
measure: Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
timeFrame: 24 weeks
measure: Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
timeFrame: 52 weeks
measure: Change in Tampa Scale of Kinesiophobia (TSK) from baseline
timeFrame: 12 weeks
measure: Change in Tampa Scale of Kinesiophobia (TSK) from baseline
timeFrame: 24 weeks
measure: Change in Tampa Scale of Kinesiophobia (TSK) from baseline
timeFrame: 52 weeks
measure: Cost-effectiveness of dCBT-I
timeFrame: 12 weeks
measure: Cost-effectiveness of dCBT-I
timeFrame: 24 weeks
measure: Changes in brain structure
timeFrame: 12 weeks
measure: Changes in brain functional connectivity
timeFrame: 12 weeks
measure: Changes in neurotransmitter concentration in the insular
timeFrame: 12 weeks
measure: Changes in brain function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: University of Oxford
name: Anushka Soni, Dr
role: PRINCIPAL_INVESTIGATOR
References: