Improving sleep and learning in rehabilitation after stroke, part 2 (INSPIRES2): study protocol for a home-based randomised control trial of digital cognitive behavioural therapy (dCBT) for insomnia

Matthew Weightman; Barbara Robinson; Ricky Fallows; Alasdair L Henry; Simon D Kyle; Emma Garratt; Anton Pick; Rachel Teal; Sara Ajina; Nele Demeyere; Colin A Espie; Ben Seymour; Heidi Johansen-Berg; Melanie K Fleming

doi:10.1136/bmjopen-2023-071764

Improving sleep and learning in rehabilitation after stroke, part 2 (INSPIRES2): study protocol for a home-based randomised control trial of digital cognitive behavioural therapy (dCBT) for insomnia

BMJ Open. 2023 Apr 6;13(4):e071764. doi: 10.1136/bmjopen-2023-071764.

Authors

Matthew Weightman¹, Barbara Robinson², Ricky Fallows³, Alasdair L Henry^{4

5}, Simon D Kyle⁵, Emma Garratt⁶, Anton Pick⁷, Rachel Teal⁸, Sara Ajina^{9

10}, Nele Demeyere^{11

12}, Colin A Espie^{4

5}, Ben Seymour², Heidi Johansen-Berg², Melanie K Fleming²

Affiliations

¹ Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK matthew.weightman@ndcn.ox.ac.uk.
² Wellcome Centre For Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
³ Patient and Public Involvement (PPI) Author, Oxford, UK.
⁴ Big Health Ltd, London, UK.
⁵ Sir Jules Thorn Sleep & Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
⁶ Oxfordshire Stroke Rehabilitation Unit (OSRU), Oxford Health NHS Foundation Trust, Oxford, UK.
⁷ Oxford Centre for Enablement (OCE), Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
⁸ MRC Stroke Unit, Oxford Centre for Enablement (OCE), Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
⁹ Department of Rehabilitation and Therapy Services, National Hospital for Neurology and Neurosurgery, University College London NHS Foundation Trust, London, UK.
¹⁰ Wellcome Centre for Human Neuroimaging, Queen Square Institute of Neurology, University College London (UCL), London, UK.
¹¹ Wolfson Centre for the Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
¹² Cognitive Neuropsychology Centre, Department of Experimental Psychology, Oxford University, Oxford, UK.

Abstract

Introduction: Consolidation of motor skill learning, a key component of rehabilitation post-stroke, is known to be sleep dependent. However, disrupted sleep is highly prevalent after stroke and is often associated with poor motor recovery and quality of life. Previous research has shown that digital cognitive behavioural therapy (dCBT) for insomnia can be effective at improving sleep quality after stroke. Therefore, the aim of this trial is to evaluate the potential for sleep improvement using a dCBT programme, to improve rehabilitation outcomes after stroke.

Methods and analysis: We will conduct a parallel-arm randomised controlled trial of dCBT (Sleepio) versus treatment as usual among individuals following stroke affecting the upper limb. Up to 100 participants will be randomly allocated (2:1) into either the intervention (6-8 week dCBT) or control (continued treatment as usual) group. The primary outcome of the study will be change in insomnia symptoms pre to post intervention compared with treatment as usual. Secondary outcomes include improvement in overnight motor memory consolidation and sleep measures between intervention groups, correlations between changes in sleep behaviour and overnight motor memory consolidation in the dCBT group and changes in symptoms of depression and fatigue between the dCBT and control groups. Analysis of covariance models and correlations will be used to analyse data from the primary and secondary outcomes.

Ethics and dissemination: The study has received approval from the National Research Ethics Service (22/EM/0080), Health Research Authority (HRA) and Health and Care Research Wales (HCRW), IRAS ID: 306 291. The results of this trial will be disseminated via presentations at scientific conferences, peer-reviewed publication, public engagement events, stakeholder organisations and other forms of media where appropriate.

Trial registration number: NCT05511285.

Keywords: REHABILITATION MEDICINE; SLEEP MEDICINE; Stroke.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cognitive Behavioral Therapy* / methods
Humans
Quality of Life
Randomized Controlled Trials as Topic
Sleep
Sleep Initiation and Maintenance Disorders* / etiology
Sleep Initiation and Maintenance Disorders* / therapy
Stroke Rehabilitation*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT05511285

Abstract

Publication types

MeSH terms

Associated data

Grants and funding