Improving Sleep in Rehabilitation After Stroke

Study 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.

Official Title
-----------------
An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia (Sleepio) to Improve Sleep After Stroke.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Digital cognitive behavioural therapy for insomnia
* Behavioral: Sleep hygiene information


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomised (1:1 ratio) to the intervention or control group, using a computer generated minimisation method, with minimisation of between groups differences in age and baseline self-reported sleep quality (sleep condition indicator score)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital CBT-I<br>6 weeks digital (online) cognitive behavioural therapy for insomnia | Behavioral: Digital cognitive behavioural therapy for insomnia<br>* 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online<br>* Other names: Sleepio;|
| Active Comparator: Sleep hygiene information<br>Leaflet of sleep hygiene information | Behavioral: Sleep hygiene information<br>* A leaflet detailing advice to improve sleep through changes in sleep hygiene<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Condition Indicator score | Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of change in Sleep Condition Indicator score | Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality | 16 weeks | 
| Change in sleep fragmentation | Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep | 8 weeks | 
| Maintenance of change in sleep fragmentation | Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep | 16 weeks | 
| Change in wake after sleep onset | Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep | 8 weeks | 
| Maintenance of change in wake after sleep onset | Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep | 16 weeks | 
| Change in sleep onset latency | Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality | 8 weeks | 
| Maintenance of change in sleep onset latency | Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality | 16 weeks | 
| Change in self-reported depression | Change in PHQ9, range 0-20, higher values indicate more depressive symptoms | 8 weeks | 
| Maintenance of change in self-reported depression | Change in PHQ9, range 0-20, higher values indicate more depressive symptoms | 16 weeks | 
| Change in self-reported anxiety | Change in GAD7, range 0-21, higher values indicate more anxiety symptoms | 8 weeks | 
| Maintenance of change in self-reported anxiety | Change in GAD7, range 0-21, higher values indicate more anxiety symptoms | 16 weeks | 
| Change in stroke specific quality of life | Change in SIS-8, range 0-40, higher values less impact of stroke on quality of life | 8 weeks | 
| Maintenance of change in stroke specific quality of life | Change in SIS-8, range 0-40, higher values indicate less impact of stroke on quality of life | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Rehabilitation, Digital, Cognitive Behavioural Therapy for Insomnia