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

• Published in: BMJ open 2017-10, Vol.7 (10), p.e018309-e018309
• Main Authors: Walker, Marion F, Thomas, Shirley A, Whitehead, Phillip J, Condon, Laura, Fisher, Rebecca J, Kontou, Eirini, Benford, Penny, Cobley, Christine
• Format: Article
• Language: English
• Subjects: Adaptation, Psychological; Anxiety; Anxiety - psychology; Anxiety - therapy; Caregivers; Caregivers - psychology; Depression - psychology; Depression - therapy; Evidence-based medicine; Feasibility Studies; Female; Health care policy; Health Services Research; Humans; Intervention; Male; Mental depression; Mental disorders; Mental health care; Psychotherapy; Qualitative research; Quality of Life; R&D; Rehabilitation; Research & development; Research Design; Stroke; Stroke - therapy; Well being
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2017-018309

IntroductionReducing 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 well-being. 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 analysisFeasibility RCT and nested qualitative interview study. We aim to recruit up to 40 stroke carers within 1 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 6 months include: anxiety and depression, quality of life and carer strain. Data are also collected from stroke survivors at baseline and 6 months including: level of disability, anxiety and depression, and quality of life.Ethics and disseminationFavourable 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.Trial registration number ISRCTN15643456; Pre-results.