Biopsychosocial Intervention for Stroke Carers (BISC study)
The aim of the BISC study is to evaluate whether a group intervention offering support and education based on biopsychosocial principles improves adjustment and mood outcomes in carers of stroke survivors.
However, we are not in a position to complete a large definitive trial until we have collected further information to inform the design of such a study. We are therefore undertaking the development of a manual for a group therapy intervention and will be applying this as part of a single-centre feasibility randomized controlled trial, to explore whether it is feasible and well tolerated.
Recruitment is taking place at the Stroke Unit of the Nottingham University Hospitals NHS Trust.
Project Lead: Professor Marion Walker
Co-Investigators: Dr Rebecca Fisher, Dr Penny Benford, Dr Eirini Kontou, Dr Shirley Thomas, Dr Joanna Fletcher-Smith, Dr Laura Condon
If you would like more information about the BISC study, please contact the Principal Investigator, Professor Marion Walker.
Background to the BISC study
Stroke survivors are leaving hospital earlier than ever before and returning home with support from a spouse or other informal carer. Evidence from previous research shows caring for stroke to be a demanding and complex time for carers. It can negatively impact their health, quality of life and mood, as they struggle to adjust to the consequences of what has happened to their loved one. We also know that deterioration in a carer’s health can negatively impact upon the stroke survivor’s mood and rehabilitation progress.
- To develop, tailor and target the delivery of a group intervention programme focusing on the various topics and issues that arise for carers following stroke and teaching strategies and skills to carers to reduce current and future distress, therefore aiding coping and adjustment following stroke (PHASE 1)
- Once the programme has been developed, we will then test how easy and possible it is to deliver the group treatment (PHASE 2)
The main purpose of the intervention is to improve the adjustment and mood of carers. Ultimately we would like to know if the intervention improves the long term outcome of carers of stroke patients and survivors themselves. However first, we must make sure that we can identify suitable people who would benefit from the intervention and that people are willing to complete all sessions provided.
How will we do this?/Study configuration:
This feasibility study involves two distinct phases:
PHASE 1: We will determine the content of the treatment programme by first running a number of focus groups with stroke carers to find out more about the specific and unique difficulties faced by carers, and ultimately, what they feel would be helpful to be included in the group intervention programme. A further series of focus groups with expert clinicians and researchers in this area will enable us to finalise the content of the treatment programme.
PHASE 2: We will recruit stroke survivors and their carers to this phase of study and randomly allocate half of the carers to receive the group intervention treatment and half of the carers to receive standard care. We will complete questionnaire measures with both the stroke survivor and carer pre and post random assignment to monitor the impact of the treatment programme. We will also conduct interviews with carers to explore their experiences of receiving the treatment, and also feedback on the experiences of carers receiving routine standard care.
How many trial participants do you need?
We will aim to recruit 40 participants for the main feasibility randomised controlled trial. Approximately 20 participants will be randomized to receive standard care, and 20 participants will receive group sessions, once a week for six weeks.
Am I eligible to take part?
For this single-centre feasibility study we will be recruiting carers of acute stroke patients from the Nottingham Stroke Unit. If your relative has recently had a stroke and is being treated on the Nottingham Stroke Unit then you may be approached on the ward to take part in this research.
How long will the study run for?
The BISC study will run for a total of 3 years. Participants enrolled in the trial will be involved for a total period of 6 months. Those randomly assigned to the intervention group will receive the BISC group therapy for 6 weeks. All participants will complete follow-up assessments at 6 months. Some participants will also be asked to participate in feedback interviews.
What treatment are you testing?
We aim to test a group intervention of education and support for carers of stroke survivors. Groups will be held in a non-clinical environment in the Nottingham area. An assistant psychologist (AP) will be trained to run the groups. The AP will receive direct clinical supervision from a qualified clinical psychologist. Each session will last approximately 2 hours and will include a 15-minute tea/coffee break which will allow participants to socialize and each session will end with a 15-minute relaxation exercise.
The group programme is based on a biopsychosocial framework, which proposes that personal wellbeing is determined by an interplay of biological (physical health), psychological (thoughts, emotions and behaviours) and social (relationships and roles, activities) factors. The sessions are designed to teach individuals to identify and use skills to reduce current future distress, thus aiding coping and adjustment to the impact of stroke and their role as a carer. For each session there will be a presentation containing information about a topic and exercises to aid group discussion. Participants will be encouraged to practice skills and strategies covered during the group sessions in their own time. The precise content of the sessions will be formalized following the findings of the focus groups with carers and nominal groups with experts.
Participants in the control group will not receive the group CBT intervention but will have access to all other usual services.
The study is being funded by a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) grant.
The BISC study is an independent research study funded by the National Institute for Health Research (Research for Patient Benefit Programme, Behavioural Intervention for Stroke Carers – a feasibility study, PB-PG-0613-31064). The views expressed in this webpage are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.