An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Oxford
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
This study evaluates the efficacy of digital cognitive behavioural therapy for insomnia (Sleepio) in chronic stroke survivors. Half of the participants will receive access to the digital (online) programme, half will receive a leaflet with sleep hygiene information. The primary outcome will be changes in sleep quality, assessed as the score on the Sleep Condition Indicator.
Detailed Description
Stroke is one of the leading causes of adult disability. Many stroke survivors report difficulties with sleep and our current research confirms this, indicating that chronic community dwelling stroke survivors experience poorer self-reported and objective sleep quality than age matched healthy controls. "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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is willing and able to give informed consent for participation in the study.
- •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
- •Serious physical health concerns with surgery scheduled in the next 5 months
- •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
Outcomes
Primary Outcomes
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
Time Frame: 8 weeks
Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score and sex using Analysis of Covariance
Secondary Outcomes
- Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score(16 weeks)
- Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline(8 weeks)
- Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Wake After Sleep Onset at Post-intervention Adjusted for Baseline(8 weeks)
- Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Change in Sleep Onset Latency(8 weeks)
- Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline(8 weeks)
- Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline(8 weeks)
- Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline(8 weeks)
- Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline(16 weeks)