MedTrace Logo

A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia

NCT05962138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

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.

Sponsors & Collaborators

  • Big Health Ltd.

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Anushka Soni, Dr · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-02-28
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962138 on ClinicalTrials.gov