Stroke
Conditions
Keywords
Sleep, Rehabilitation, Digital, Cognitive Behavioural Therapy for Insomnia
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.
Interventions
6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online
BEHAVIORALSleep hygiene information
A leaflet detailing advice to improve sleep through changes in sleep hygiene
Sponsors
Big Health Inc.
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be told that they will be assigned to one of two groups but will not be told whether one is hypothesised to be superior over another
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score | 16 weeks | Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance. |
| Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline | 8 weeks | Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software which does the calculation the definition of sleep fragmentation index is the sum of the Mobile time (%)' and the 'Immobile bouts \<=1min (%).There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance. |
| Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline | 16 weeks | Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software that does the calculation, the definition of sleep fragmentation index is the sum of the Mobile time (%)' and the 'Immobile bouts \<=1min (%).There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance |
| Wake After Sleep Onset at Post-intervention Adjusted for Baseline | 8 weeks | Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance |
| Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline | 16 weeks | Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance. |
| Change in Sleep Onset Latency | 8 weeks | Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality |
| Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline | 16 weeks | PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance |
| Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline | 8 weeks | GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance |
| Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline | 16 weeks | GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance |
| Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline | 8 weeks | SIS-8 index, range 0-100, higher values less impact of stroke on quality of life. Assessed at baseline and post-interventin. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance |
| Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline | 16 weeks | SIS-8 index, range 0-100, higher values indicate less impact of stroke on quality of life. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance |
| Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline | 8 weeks | PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness | 16 weeks | Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems |
Countries
United Kingdom
Participant flow
Pre-assignment details
2 participants failed to undergo the baseline assessment following consent, and were not randomised to group. Therefore, although 86 participants consented, the total started in the study when divided by group is 84
Participants by arm
| Arm | Count |
|---|---|
| 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 | 48 |
| Sleep Hygiene Information Leaflet of sleep hygiene information
Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene | 36 |
| Total | 84 |
Baseline characteristics
| Characteristic | Digital CBT-I | Total | Sleep Hygiene Information |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 12.7 | 58.6 years STANDARD_DEVIATION 13.5 | 58.7 years STANDARD_DEVIATION 14.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 48 participants | 84 participants | 36 participants |
| Sex: Female, Male Female | 17 Participants | 39 Participants | 22 Participants |
| Sex: Female, Male Male | 31 Participants | 45 Participants | 14 Participants |
| Time since most recent stroke, years | 6 years STANDARD_DEVIATION 5 | 6 years STANDARD_DEVIATION 5 | 6 years STANDARD_DEVIATION 5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 |
| other Total, other adverse events | 0 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 |
Outcome results
Primary
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
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
Time frame: 8 weeks
Population: Intention to treat population, using multiple imputation. Mean and standard deviation are pooled across original (complete case) data and 5 imputations
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex | 18.06 score on a scale |
| Sleep Hygiene Information | Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex | 14.72 score on a scale |
p-value: <0.021ANCOVA
Secondary
Change in Sleep Onset Latency
Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality
Time frame: 8 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Change in Sleep Onset Latency | 18 minutes |
| Sleep Hygiene Information | Change in Sleep Onset Latency | 28 minutes |
p-value: 0.01495% CI: [2, 18]ANCOVA
Secondary
Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline
GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Time frame: 16 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline | 5.66 score on a scale |
| Sleep Hygiene Information | Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline | 6.75 score on a scale |
p-value: 0.22995% CI: [-0.7, 2.87]ANCOVA
Secondary
Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline
GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Time frame: 8 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline | 5.28 score on a scale |
| Sleep Hygiene Information | Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline | 6.90 score on a scale |
p-value: 0.05495% CI: [-0.03, 3.25]ANCOVA
Secondary
Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline
PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Time frame: 16 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline | 5.93 score on a scale |
| Sleep Hygiene Information | Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline | 8.22 score on a scale |
p-value: 0.03695% CI: [0.149, 4.44]ANCOVA
Secondary
Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline
PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Time frame: 8 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline | 5.9 score on a scale |
| Sleep Hygiene Information | Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline | 7.7 score on a scale |
p-value: 0.0395% CI: [0.18, 3.5]ANCOVA
Secondary
Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score
Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance.
Time frame: 16 weeks
Population: Complete case analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score | 18.9 score on a scale |
| Sleep Hygiene Information | Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score | 16.0 score on a scale |
p-value: 0.05995% CI: [-0.106, 5.822]ANCOVA
Secondary
Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline
Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software which does the calculation the definition of sleep fragmentation index is the sum of the Mobile time (%)' and the 'Immobile bouts \<=1min (%).There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance.
Time frame: 8 weeks
Population: Complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline | 30.8 index (no units) |
| Sleep Hygiene Information | Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline | 32.1 index (no units) |
p-value: 0.59695% CI: [-3.5, 6]ANCOVA
Secondary
Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline
Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software that does the calculation, the definition of sleep fragmentation index is the sum of the Mobile time (%)' and the 'Immobile bouts \<=1min (%).There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Time frame: 16 weeks
Population: Complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline | 29.3 index (no units) |
| Sleep Hygiene Information | Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline | 33.8 index (no units) |
p-value: 0.03195% CI: [0.431, 8.612]ANCOVA
Secondary
Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline
SIS-8 index, range 0-100, higher values less impact of stroke on quality of life. Assessed at baseline and post-interventin. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Time frame: 8 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline | 51.8 score on a scale |
| Sleep Hygiene Information | Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline | 50.4 score on a scale |
p-value: 0.50295% CI: [-5.51, 2.73]ANCOVA
Secondary
Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline
SIS-8 index, range 0-100, higher values indicate less impact of stroke on quality of life. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Time frame: 16 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline | 52.0 score on a scale |
| Sleep Hygiene Information | Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline | 52.1 score on a scale |
p-value: 0.92495% CI: [-3.63, 4]ANCOVA
Secondary
Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline
Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance.
Time frame: 16 weeks
Population: complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline | 49 minutes |
| Sleep Hygiene Information | Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline | 57 minutes |
p-value: 0.07795% CI: [-1, 17]ANCOVA
Secondary
Wake After Sleep Onset at Post-intervention Adjusted for Baseline
Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Time frame: 8 weeks
Population: Complete case analysis population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Digital CBT-I | Wake After Sleep Onset at Post-intervention Adjusted for Baseline | 53 minutes |
| Sleep Hygiene Information | Wake After Sleep Onset at Post-intervention Adjusted for Baseline | 54 minutes |
p-value: 0.88595% CI: [-7.8, 9.1]ANCOVA
Other Pre-specified
Cost Effectiveness
Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems
Time frame: 16 weeks