Study Results
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View full resultsBasic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2020-02-14
2022-01-01
Brief Summary
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Detailed Description
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"Sleepio" is an online Cognitive Behavioural Therapy for Insomnia (CBT-I) programme. The efficacy of this intervention has been demonstrated in people with chronic insomnia but has not yet been tested in people with stroke. The study therefore aims to determine whether digital CBT-I is effective for improving sleep quality in chronic stroke survivors. Participants will be randomised to receive either digital (online) CBT-I or a leaflet with sleep hygiene information. The primary outcome is the change in self-reported sleep quality, assessed using the Sleep Condition Indicator. Secondary outcomes include changes in sleep fragmentation and wake after sleep onset assessed with actigraphy, self-reported sleep onset latency from the sleep diaries, anxiety and depression using the PHQ9 and GAD7, quality of life using the SIS-8 and EQ-5D-5L as well as changes in healthcare costs during the 8 week follow up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Digital CBT-I
6 weeks digital (online) cognitive behavioural therapy for insomnia
Digital cognitive behavioural therapy for insomnia
6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online
Sleep hygiene information
Leaflet of sleep hygiene information
Sleep hygiene information
A leaflet detailing advice to improve sleep through changes in sleep hygiene
Interventions
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Digital cognitive behavioural therapy for insomnia
6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online
Sleep hygiene information
A leaflet detailing advice to improve sleep through changes in sleep hygiene
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* At least 3 months post stroke
* Interest in improving sleep
* Can understand verbal and written English well enough to engage with the programme and study procedures (with assistance from carer if needed).
* Reliable access to internet
* Currently living in the United Kingdom
* Current stable health
Exclusion Criteria
* Undergoing a psychological treatment programme for insomnia (with a health professional or online)
* Pregnancy
* Uncontrolled seizures
* Untreated diagnosed obstructive sleep apnoea
* Habitual night shift, evening or rotating shift-workers
* Other serious clinical condition that may affect participation in the study
18 Years
ALL
No
Sponsors
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Big Health Inc.
INDUSTRY
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Heidi Johansen-Berg, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford, UK
Locations
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Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, , United Kingdom
Countries
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References
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Fleming MK, Smejka T, Macey E, Luengo-Fernandez R, Henry AL, Robinson B, Kyle SD, Espie CA, Johansen-Berg H. Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia. J Sleep Res. 2024 Apr;33(2):e13971. doi: 10.1111/jsr.13971. Epub 2023 Jul 5.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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INSPIRES
Identifier Type: -
Identifier Source: org_study_id
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