A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia

NCT05962138 | Active Not Recruiting

• 1 other identifier: 252762
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep; digital; cognitive behavioural therapy for insomnia; fibromyalgia; pain; cognition

Outcome Measures

Primary Outcomes (1)

• Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline

  The revised Fibromyalgia Impact Questionnaire (FIQR), range 0-100, is a self-reported measure designed to assess the overall impact of fibromyalgia on patients' lives, capturing domains such as physical impairment, overall well-being, and the intensity of symptoms like pain, fatigue, stiffness, sleep disturbances, and cognitive problems. Higher scores indicate more severe symptoms.

  12 weeks

Secondary Outcomes (15)

• Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline

  24 weeks

• Sleep quality

  12 weeks

• Change in Revised Fibromyalgia Impact Questionnaire (FIQR) from baseline

  52 weeks

• Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline

  12 weeks

• Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline

  24 weeks

Study Arms (2)

Sleepio (dCBT-I)

EXPERIMENTAL

6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. Participants will also receive a booklet with general advice for patients with fibromyalgia, including sleep hygiene.

Behavioral: Digital Cognitive Behavioural Therapy for Insomnia

Treatment as usual

NO INTERVENTION

Participants will receive a booklet published by Versus Arthritis designed for patients with fibromyalgia with general advice, including sleep hygiene.

Interventions

Digital Cognitive Behavioural Therapy for Insomnia BEHAVIORAL

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.

Also known as: Sleepio

Sleepio (dCBT-I)

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of fibromyalgia
• Concomitant insomnia, frequent waking in the night or early morning waking
• Self-reported difficulties with concentration or memory
• Reliable internet access

You may not qualify if:

• Patients with a poor understanding of English.
• Patients with known neurological or psychiatric conditions (other than depression or anxiety) likely to independently affect the results of pain assessment, for example peripheral diabetic neuropathy in the opinion of the research team
• Major neuropsychiatric disorder (bipolar disorder, schizophrenia or psychotic spectrum disorders)
• Epilepsy
• Cognitive impairment, dementia or neurodegenerative disorder
• Recent or planned surgery
• Current or planned night-time shift work
• Sleep disorders such as sleep apnoea, restless leg syndrome, circadian rhythm disorder, or parasomnia
• Taking prescribed sleep medications on more than 2 nights in past 2 weeks
• Currently receiving other psychological therapy for insomnia
• Pregnant or lactating

Sponsors & Collaborators

• University of Oxford: lead
• Big Health Ltd.: collaborator

Study Sites (1)

University of Oxford

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anushka Soni, Dr

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Baseline assessment, randomisation and facilitation of the intervention will be performed by members of the research team who will be blinded to group allocation. The investigators analysing the data will be blinded to group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised controlled trial with two parallel study arms: (1) digital cognitive behavioural therapy for insomnia (experimental condition), and (2) treatment as usual (control condition). Randomisation will be using a 1:1 ratio (experimental:control), within minimisation of between group differences in sex, and inclusion status in imaging sub-study

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 27, 2023
• Study Start: June 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: November 30, 2025
• Last Updated: May 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of results
• Access Criteria: Available upon reasonable request

Locations

GB (1)