The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia

Summary

The goal of this clinical trial is to learn if a digital sleep therapy program (digital Cognitive Behavioural Therapy for Insomnia or dCBT-I) works to improve quality of life and movement in adults with fibromyalgia who also have trouble sleeping. The main questions it aims to answer are:

* Does digital sleep therapy improve quality of life for people with fibromyalgia?
* Does digital sleep therapy improve sleep quality?
* Does better sleep help reduce fear of movement and increase physical activity, assessed in a virtual reality (VR) environment?

Researchers will compare digital sleep therapy (called 'Sleepio') to standard care with sleep advice materials.

Participants will:

* Use the Sleepio program at home for 10 weeks (6 sessions, 20 minutes each)
* Wear a sleep monitoring device at home in bed for several nights at the start and after 3 months
* Wear an activity watch for 1 week to track movement at the start and after 3 months
* Complete questionnaires about pain, sleep, mood, and daily activities at the start, 3 months, and 6 months
* Visit the study centre twice for assessments that include:

* Pain sensitivity testing
* A virtual reality game that measures how they move and make decisions
* Recording of simple exercises like marching and squats

Participation in the study lasts about 6 months.

Conditions

• Fibromyalgia

Interventions

BEHAVIORAL

Digital Cognitive Behavioural Therapy for Insomnia

Sleepio is a digital cognitive behavioural therapy for insomnia program consisting of 6 automated sessions delivered over 10 weeks (approximately 20 minutes per session). The program features an animated virtual professor and includes evidence-based cognitive and behavioral interventions, sleep hygiene education, sleep restriction therapy, stimulus control, cognitive restructuring, and relaxation techniques. Participants access the program via web browser or smartphone app at their convenience. The program includes a daily sleep diary, access to an online community, and a library of resources. Adherence is supported through automated text reminders via REDCap and telephone/video check-ins with research staff at weeks 1, 3, and 6 of the intervention period.

BEHAVIORAL

Sleep Hygiene Education Materials

Written educational materials produced by Versus Arthritis charity providing evidence-based advice on sleep hygiene for people with fibromyalgia. Materials include information booklets and links to video resources covering sleep management strategies, understanding the relationship between sleep and pain, and practical tips for improving sleep quality.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• Ben Seymour, PhD · University of Oxford

• Anushka Soni, DPhil · [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United Kingdom

Study Locations