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

NCT07465991 | Recruiting

• 1 other identifier: 252762-2
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

fibromyalgia; CBT-I; Cognitive behavioural therapy for insomnia; fear of movement; insomnia; actigraphy; virtual reality; chronic pain

Outcome Measures

Primary Outcomes (1)

• Change in Fibromyalgia-Related Quality of Life (FIQR)

  Change in fibromyalgia-related quality of life measured by the Revised Fibromyalgia Impact Questionnaire (FIQR) at 3 and 6 months. The FIQR is a 21-item validated questionnaire assessing the impact of fibromyalgia on physical function, overall impact, and symptom severity. Total scores range from 0 to 100, with higher scores indicating greater impact of fibromyalgia on quality of life.

  From enrollment to the end of follow up at 6 months

Secondary Outcomes (10)

• Sleep Quality (Pittsburgh Sleep Quality Index)

  From enrollment to the end of follow up at 6 months

• Change in Pain Severity (Numerical Rating Scale)

  From enrollment to end of follow up at 6 months

• Fear of Movement (Tampa Scale of Kinesiophobia)

  From enrollment to the end of follow up at 6 months

• Fatigue (Chalder Fatigue Scale)

  From enrollment to the end of follow up at 6 months

• Depression Symptoms (PHQ-9)

  From enrollment to the end of follow up at 6 months

Other Outcomes (11)

• Sleep continuity on EEG

  From enrolment to three months' follow-up

• Sleep architecture on EEG

  From enrolment to three months' follow-up

• Sleep spectral power on EEG

  From enrolment to three months' follow-up

Study Arms (2)

Digital Cognitive Behavioural Therapy for Insomnia

EXPERIMENTAL

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

Behavioral: Digital Cognitive Behavioural Therapy for Insomnia; Behavioral: Sleep Hygiene Education Materials

Standard Care with Sleep Hygiene Education

ACTIVE COMPARATOR

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.

Behavioral: Sleep Hygiene Education Materials

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.

Also known as: Sleepio, dCBT-I

Digital Cognitive Behavioural Therapy for Insomnia

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.

Digital Cognitive Behavioural Therapy for Insomnia; Standard Care with Sleep Hygiene Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent for participation in the study
• Male or female, aged 18 years or above
• Clinical diagnosis of fibromyalgia or chronic widespread pain
• Concomitant insomnia, frequent nighttime waking, or early morning waking
• Self-reported difficulties with concentration or memory
• Reliable internet access (required to access digital intervention)

You may not qualify if:

• Poor understanding of English
• Known neurological conditions (other than depression or anxiety) likely to independently affect pain assessment results (e.g., peripheral diabetic neuropathy)
• Major neuropsychiatric disorder (bipolar disorder, schizophrenia, or psychotic spectrum disorders)
• Epilepsy
• Cognitive impairment, dementia, or neurodegenerative disorder
• Recent surgery (within past 3 months) or planned surgery during study period
• Current night-time shift work or planned night-time shift work during study period
• Diagnosed sleep disorders including sleep apnea, restless leg syndrome, circadian rhythm disorder, or parasomnia
• Taking prescribed sleep medications on more than 2 nights in the past 2 weeks
• Currently receiving other psychological therapy for insomnia
• Pregnant or lactating

Sponsors & Collaborators

• University of Oxford: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (2)

Oxford Centre for Integrative Neuroimaging

Oxford, OX3 9DU, United Kingdom

NOT YET RECRUITING

University of Oxford

Oxford, OX3 9DU, United Kingdom

RECRUITING

Related Publications (4)

• Pathak A, Kelleher EM, Brennan I, Amarnani R, Wall A, Murphy R, Lee H, Fordham B, Irani A. Treatments for enhancing sleep quality in fibromyalgia: a systematic review and meta-analysis. Rheumatology (Oxford). 2025 Aug 1;64(8):4495-4516. doi: 10.1093/rheumatology/keaf147.

  PMID: 40084994 RESULT

• Choy EHS. The role of sleep in pain and fibromyalgia. Nature Reviews Rheumatology. 2015;11(9):513-20.

  RESULT

• Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, et al. A randomized, placebocontrolled trial of online cognitive behavioural therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012;35(6):769-81.

  RESULT

• Selvanathan J, Pham C, Nagappa M, Peng PWH, Englesakis M, Espie CA, et al. Cognitive behavioural therapy for insomnia in patients with chronic pain - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2021;60:101460.

  RESULT

MeSH Terms

Conditions

Fibromyalgia; Kinesiophobia; Sleep Initiation and Maintenance Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Seymour, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Anushka Soni, DPhil

  anushka.soni@ndorms.ox.ac.uk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Wall, BSc MSc

CONTACT

+44 1865 611450; amanda.wall@ndcn.ox.ac.uk

Eoin Kelleher, MB BCh DPhil

CONTACT

eoin.kelleher@ndcn.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

GB (2)