The START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the effectiveness of a manual based coping strategy programme in promoting the mental health of carers of people with dementia

Family carers of people with dementia are a group at high risk of mental health problems. As they provide most of the care received by people with dementia in this country, and the number of people with dementia is projected to increase substantially, there is an urgent need within society to develop ways to decrease their distress. The UK government has recognised that family dementia carers need dedicated psychological therapies, and that this should be a key component of high quality dementia care, but in practice resources are not available. The only randomised controlled trials that have demonstrated efficacy of a manual based psychological therapy in this group were carried out in the USA and the therapy was conducted by clinical psychologists. Clinical psychologists are a highly trained and finite resource within the NHS. Programmes of stepped care, in which mental health workers deliver therapy supervised by clinical psychologists, have been devised to widen availability of psychological therapies. We plan to test the feasibility, effectiveness in terms of carer mental health and cost-effectiveness of an individual psychological manual based intervention for family carers, delivered by supervised graduate mental health workers as part of NHS care. This would be the first study to test a manual based therapy for dementia carers in an Randomised Controlled Trial (RCT) in the UK, and the first study worldwide to test the effectiveness of graduate mental health workers delivering therapy to this group PRIMARY RESEARCH QUESTION: Does a programme "helping family carers for people with dementia cope" in addition to usual care decrease carer anxiety and depression over two years when compared to usual care only? If so what is the difference in financial costs in relation to how well the intervention works? SECONDARY QUESTIONS: Does the therapy delay the person with dementia entering a care home or other 24-hour care, or improve the coping style the carer uses or their quality of life (QoL)? Is there an effect on the patient's QoL? Do demographic and illness characteristics of the carer and patient influence the outcome? HOW SUCCESS OF THE THERAPY WILL BE JUDGED: We will measure depression and anxiety at baseline, and at four timepoints after that: 4 and 8 months and 1 and 2 years. We will see whether anxiety and depression are lower in the carers who have had therapy. We will also compare the financial costs of delivering therapy and care to the two groups and report these in relation to how well the therapy works. We will look at whether carers who have had the therapy report caring better with the demands of caring,or having better quality of life and if they are able to keep the person they are looking after at home longer.