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

The frequency of dementia is rising as people live longer, meaning that there are more people with dementia, two-thirds of whom are cared for at home by their families. About 40% of those family carers of people with dementia have clinically significant depression or anxiety, often leading to them becoming unable to care so that the person with dementia has to be looked after in a care home. Although there have been some interventions which help reduce family carers’ depression and anxiety, they have neither been designed to be used routinely in the NHS nor had their cost-effectiveness tested. Our START (STrAtegies for RelaTives) study was a randomised controlled trial of an eight-session manual, adapted from an American programme called ‘Coping with Caregiving’. It was delivered by psychology graduates to carers individually. We compared it with usual treatment by using a computer program to decide randomly whether or not carers should be in the intervention or the control group. We found that START decreased carers’ anxiety and depression and improved their quality of life (QoL) in the short term (8 months after the study started) and that it was as effective on these measures in the longer term (2 years after the study started). The intervention was cost-effective at both times but did not improve the person with dementia’s QoL. After 2 years, there was a small, but not significant, decrease in the chance of people with dementia in the intervention group being admitted to a care home.