Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962138
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-06-26
Brief Title:
A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Characterisation of Pain in Patients With Musculoskeletal Disease a Prospective Longitudinal Observational Study With an Embedded Feasibility Window of Opportunity Sleep Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pain-LESS
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 andor 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
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 andor 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 Sleepios 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 11 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 andor 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
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 Sleepios 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 11 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None