A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia

Fibromyalgia Clinical Trial

— Pain-LESS  

Official title:

Characterisation of Pain in Patients With Musculoskeletal Disease: a Prospective, Longitudinal, Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962138
• Other study ID #: 252762
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: University of Oxford
• Contact: Anushka Soni, Dr
• Phone: +441865 234829
• Email: anushka.soni[@]ndorms.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 30, 2025
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Digital Cognitive Behavioural Therapy for Insomnia
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.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Big Health Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	24 weeks
Secondary	Sleep quality	Changes in sleep pattern on actigraphy between treatment groups	12 weeks
Secondary	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.	52 weeks
Secondary	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.	12 weeks
Secondary	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.	24 weeks
Secondary	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.	52 weeks
Secondary	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.	12 weeks
Secondary	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.	24 weeks
Secondary	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.	52 weeks
Secondary	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 (£).	12 weeks
Secondary	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 (£).	24 weeks
Secondary	Changes in brain structure	Change in brain grey matter volume on structural MRI	12 weeks
Secondary	Changes in brain functional connectivity	Changes in brain resting state functional connectivity on resting-state functional MRI	12 weeks
Secondary	Changes in neurotransmitter concentration in the insular	Changes in neurotransmitter concentration in the insular on magnetic resonance spectroscopy	12 weeks
Secondary	Changes in brain function	Changes in brain resting state activity on arterial spin labelling (ASL) on brain MRI	12 weeks