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

Sponsor
University of Oxford
Study ID
NCT07465991
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital Cognitive Behavioural Therapy for Insomnia — BEHAVIORAL
    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.
  • Sleep Hygiene Education Materials — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Mar 12, 2026
Start date
Jan 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital Cognitive Behavioural Therapy for Insomnia
    Participants in this arm will receive access to Sleepio, a digital cognitive behavioural therapy for insomnia (dCBT-I) program. The intervention consists of 6 automated sessions (approximately 20 minutes each) delivered over 10 weeks via web browser or smartphone app. Sessions include evidence-based cognitive and behavioral interventions, sleep hygiene education, time-in-bed restriction, and relaxation exercises. Participants have access to a daily online sleep diary, an online community, and library of resources. SMS reminders will be sent to encourage compliance, and participants will receive telephone or video check-ins from a study investigator at weeks 1, 3, and 6. Participants will also be provided with written sleep hygiene materials from Versus Arthritis, and continue to receive their standard NHS care
  • Active Comparator: Standard Care with Sleep Hygiene Education
    Participants in this arm will be provided with written sleep hygiene materials from Versus Arthritis, and continue to receive their standard NHS care. Materials include information booklets and video resources on managing fibromyalgia and improving sleep. Participants do not receive access to the Sleepio digital CBT-I program but continue with routine clinical care during the study period.

Primary Outcome Measure

Change in Fibromyalgia-Related Quality of Life (FIQR) [ Time Frame: From enrollment to the end of follow up at 6 months ]

Central Contacts

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