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ACTIVE NOT RECRUITING
NCT05962138
NA

A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia

Sponsor: University of Oxford

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-06-01

Completion Date

2025-11-30

Last Updated

2025-05-18

Healthy Volunteers

No

Conditions

Interventions

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 (1)

University of Oxford

Oxford, United Kingdom