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Biopsychosocial Intervention for Stroke Carers (BISC): protocol for a feasibility randomized controlled trial

Walker, Marion F.; Thomas, Shirley A.; Whitehead, Phillip J.; Condon, Laura; Fisher, Rebecca J.; Kontou, Eirini; Benford, Penny; Cobley, Christine

Authors

Marion F. Walker

Phillip J. Whitehead

REBECCA FISHER rebecca.fisher@nottingham.ac.uk
Stroke Association Hrh The Princess Margaret Senior Lecturership (Principal Research Fellow)

Penny Benford

Christine Cobley



Abstract

Introduction

Reducing length of hospital stay for stroke survivors often creates a shift in the responsibility of care towards informal carers. Adjustment to the caregiving process is experienced by many carers as overwhelming, complex and demanding, and can have a detrimental impact on mental and physical health and wellbeing. National policy guidelines recommend that carers’ needs are considered and addressed; despite this, few interventions have been developed and empirically evaluated. We developed a biopsychosocial intervention in collaboration with carers of stroke survivors. Our aim is to determine whether the intervention can be delivered in a group setting and evaluated using a randomised controlled trial (RCT).

Methods and Analysis

Feasibility randomised controlled trial (RCT) and nested qualitative interview study. We aim to recruit up to 40 stroke carers within one year of the stroke onset. Carers are randomised to usual care or usual care plus biopsychosocial intervention. Each intervention group will consist of five stroke carers. The intervention will focus on: psychoeducation, psychological adjustment to stroke, strategies for reducing unwanted negative thoughts and emotions, and problem solving strategies. The main outcome is the feasibility of conducting an RCT. Carer outcomes at six months include: anxiety and depression, quality of life, and carer strain. Data is also collected from stroke survivors at baseline and six months including: level of disability, anxiety and depression, and quality of life.

Ethics and Dissemination

Favourable ethical opinion was provided by East Midlands – Nottingham2 Research Ethics Committee (14/EMI/1264). This study will determine whether delivery of the biopsychosocial intervention is feasible and acceptable to stroke carers within a group format. It will also determine whether it is feasible to evaluate the effects of the biopsychosocial intervention in an RCT. We will disseminate our findings through peer-reviewed publications and presentations at national and international conferences.

Citation

Walker, M. F., Thomas, S. A., Whitehead, P. J., Condon, L., Fisher, R. J., Kontou, E., …Cobley, C. (in press). Biopsychosocial Intervention for Stroke Carers (BISC): protocol for a feasibility randomized controlled trial. BMJ Open, 7, https://doi.org/10.1136/bmjopen-2017-018309

Journal Article Type Article
Acceptance Date Sep 20, 2017
Online Publication Date Oct 22, 2017
Deposit Date Sep 22, 2017
Publicly Available Date Oct 22, 2017
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 7
Article Number e018309
DOI https://doi.org/10.1136/bmjopen-2017-018309
Public URL http://eprints.nottingham.ac.uk/id/eprint/46621
Publisher URL http://bmjopen.bmj.com/content/7/10/e018309
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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