A Study of Digital Cognitive Behavioural Therapy for Insomnia in Fibromyalgia

NCT ID: NCT05962138

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-11-30

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.

Detailed Description

Fibromyalgia patients commonly experience cognitive issues such as concentration and memory difficulties and sleep disorders. Despite the prevalence of these symptoms, no established treatments currently exist. Traditional in-person Cognitive Behavioural Therapy (CBT), which focuses on modifying unhelpful thoughts and behaviours, is both expensive and challenging to deliver on a broad scale. New digital forms of CBT, specifically for insomnia (CBT-I), have shown promise in improving cognitive symptoms and sleep quality, but their effect on fibromyalgia patients is yet to be explored.

The study will investigate the efficacy of 'Sleepio', an established digital CBT-I (dCBT-I) tool. Sleepio has shown effectiveness in treating insomnia and its cognitive symptoms, offering a promising approach to address similar issues in fibromyalgia. Sleepio's approach involves six 20-minute sessions over 10 weeks with a virtual therapist who employs key cognitive and behavioural strategies to enhance sleep quality.

Participants in this study will be randomised in a 1:1 ratio to either treatment with Sleepio treatment or standard care with standard sleep hygiene advice. The primary outcome is quality of life measured on the Revised Fibromyalgia Impact Questionnaire (FIQR), 12 weeks following randomisation. Secondary outcomes include subjective cognition (British Columbia Cognitive Complaints Inventory, BC-CCI), objective cognitive function (tests of reaction time, working memory, processing speed), quantitative cognitive avoidance testing (QCAT), sleep quality (actigraphy, insomnia severity index (ISI), Pittsburgh Sleep Quality Index (PSQI), pain (NRS), fear of movement (Tampa Scale of Kinesiophobia) and quantitative movement assessment. Assessments will be carried out using online tools.

Additionally, a subset of participants will undergo sleep actigraphy and/or neuroimaging using MRI scans for a more detailed analysis.

Primary Objectives:

• Assess the impact of Sleepio (dCBT-I) on quality of life (FIQR) in fibromyalgia patients.

Secondary Objectives:

• Assess the impact of Sleepio (dCBT-I) on subjective (BC-CCI) and objective cognitive function in fibromyalgia patients.
• Investigate the effect of Sleepio on sleep quality (ISI & PSQI) in fibromyalgia patients.
• Investigate cost-effectiveness of Sleepio (dCBT-I)
• Does Sleepio improve subjective and objective measures of motor function in fibromyalgia?

As part of the study, participants will also be invited to join a research database for potential inclusion in future studies conducted by the research group.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sleepio (dCBT-I)

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.

Group Type: EXPERIMENTAL

Digital Cognitive Behavioural Therapy for Insomnia

Intervention Type: 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.

Treatment as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Sleepio

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Big Health Ltd.

UNKNOWN

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anushka Soni, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

University of Oxford

Oxford, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

252762

Identifier Type: -

Identifier Source: org_study_id