A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia (Pain-LESS)

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:

• 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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Digital Cognitive Behavioural Therapy for Insomnia

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anushka Soni, Dr; Phone Number: +441865 234829; Email: anushka.soni@ndorms.ox.ac.uk
• Study Contact Backup: Name: Eoin Kelleher, Dr; Email: fibromyalgia@ndcn.ox.ac.uk

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Recruiting
    • University of Oxford
    • Contact: Eoin Kelleher, Dr; Email: fibromyalgia@ndcn.ox.ac.uk
    • Contact: Amanda Wall; Email: amanda.wall@ndcn.ox.ac.uk
    • Sub-Investigator: Amanda Wall
    • Sub-Investigator: Eoin Kelleher, Dr
    • Principal Investigator: Anushka Soni, Dr
    • Sub-Investigator: Tamsin Hughes
    • Sub-Investigator: Vishvarani Wanigasekera, Dr
    • Sub-Investigator: Irene Tracey, Prof
    • Sub-Investigator: Ben Seymour, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleepio (dCBT-I); 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.	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.; Other Names: Sleepio
No Intervention: Treatment as usual; Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Big Health Ltd.
• Investigators: Principal Investigator: Anushka Soni, Dr, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: pain; sleep; cognition; fibromyalgia; digital; cognitive behavioural therapy for insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 252762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data are available upon reasonable request
• IPD Sharing Time Frame: Following publication of results
• IPD Sharing Access Criteria: Available upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No