search
Back to results

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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Digital Cognitive Behavioural Therapy for Insomnia
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring sleep, digital, cognitive behavioural therapy for insomnia, fibromyalgia, pain, cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of OxfordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sleepio (dCBT-I)

Treatment as usual

Arm Description

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.

Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2023
Last Updated
July 18, 2023
Sponsor
University of Oxford
Collaborators
Big Health Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05962138
Brief Title
A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Big Health Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
sleep, digital, cognitive behavioural therapy for insomnia, fibromyalgia, pain, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
Baseline assessment, randomisation and facilitation of the intervention will be performed by members of the research team who will be blinded to group allocation. The investigators analysing the data will be blinded to group allocations.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleepio (dCBT-I)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.
Intervention Type
Behavioral
Intervention Name(s)
Digital Cognitive Behavioural Therapy for Insomnia
Other Intervention Name(s)
Sleepio
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Description
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.
Time Frame
24 weeks
Title
Sleep quality
Description
Changes in sleep pattern on actigraphy between treatment groups
Time Frame
12 weeks
Title
Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Description
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.
Time Frame
52 weeks
Title
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
Description
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.
Time Frame
12 weeks
Title
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
Description
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.
Time Frame
24 weeks
Title
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline
Description
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.
Time Frame
52 weeks
Title
Change in Tampa Scale of Kinesiophobia (TSK) from baseline
Description
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.
Time Frame
12 weeks
Title
Change in Tampa Scale of Kinesiophobia (TSK) from baseline
Description
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.
Time Frame
24 weeks
Title
Change in Tampa Scale of Kinesiophobia (TSK) from baseline
Description
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.
Time Frame
52 weeks
Title
Cost-effectiveness of dCBT-I
Description
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 (£).
Time Frame
12 weeks
Title
Cost-effectiveness of dCBT-I
Description
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 (£).
Time Frame
24 weeks
Title
Changes in brain structure
Description
Change in brain grey matter volume on structural MRI
Time Frame
12 weeks
Title
Changes in brain functional connectivity
Description
Changes in brain resting state functional connectivity on resting-state functional MRI
Time Frame
12 weeks
Title
Changes in neurotransmitter concentration in the insular
Description
Changes in neurotransmitter concentration in the insular on magnetic resonance spectroscopy
Time Frame
12 weeks
Title
Changes in brain function
Description
Changes in brain resting state activity on arterial spin labelling (ASL) on brain MRI
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anushka Soni, Dr
Phone
+441865 234829
Email
anushka.soni@ndorms.ox.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Eoin Kelleher, Dr
Email
fibromyalgia@ndcn.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anushka Soni, Dr
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eoin Kelleher, Dr
Email
fibromyalgia@ndcn.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Amanda Wall
Email
amanda.wall@ndcn.ox.ac.uk
First Name & Middle Initial & Last Name & Degree
Amanda Wall
First Name & Middle Initial & Last Name & Degree
Eoin Kelleher, Dr
First Name & Middle Initial & Last Name & Degree
Anushka Soni, Dr
First Name & Middle Initial & Last Name & Degree
Tamsin Hughes
First Name & Middle Initial & Last Name & Degree
Vishvarani Wanigasekera, Dr
First Name & Middle Initial & Last Name & Degree
Irene Tracey, Prof
First Name & Middle Initial & Last Name & Degree
Ben Seymour, Prof

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia

We'll reach out to this number within 24 hrs