Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial

OBJECTIVE To assess whether a manual based coping strategy compared with treatment as usual reduces depression and anxiety symptoms in carers of family members with dementia. DESIGN Randomised, parallel group, superiority trial. SETTING Three mental health community services and one neurological outpatient dementia service in London and Essex, UK. PARTICIPANTS 260 carers of family members with dementia. INTERVENTION A manual based coping intervention comprising eight sessions and delivered by supervised psychology graduates to carers of family members with dementia. The programme consisted of psychoeducation about dementia, carers' stress, and where to get emotional support; understanding behaviours of the family member being cared for, and behavioural management techniques; changing unhelpful thoughts; promoting acceptance; assertive communication; relaxation; planning for the future; increasing pleasant activities; and maintaining skills learnt. Carers practised these techniques at home, using the manual and relaxation CDs. MAIN OUTCOME MEASURES Affective symptoms (hospital anxiety and depression total score) at four and eight months. Secondary outcomes were depression and anxiety caseness on the hospital anxiety and depression scale; quality of life of both the carer (health status questionnaire, mental health) and the recipient of care (quality of life-Alzheimer's disease); and potentially abusive behaviour by the carer towards the recipient of care (modified conflict tactics scale). RESULTS 260 carers were recruited; 173 were randomised to the intervention and 87 to treatment as usual. Mean total scores on the hospital anxiety and depression scale were lower in the intervention group than in the treatment as usual group over the eight month evaluation period: adjusted difference in means -1.80 points (95% confidence interval -3.29 to -0.31; P=0.02) and absolute difference in means -2.0 points. Carers in the intervention group were less likely to have case level depression (odds ratio 0.24, 95% confidence interval 0.07 to 0.76) and there was a non-significant trend towards reduced case level anxiety (0.30, 0.08 to 1.05). Carers' quality of life was higher in the intervention group (difference in means 4.09, 95% confidence interval 0.34 to 7.83) but not for the recipient of care (difference in means 0.59, -0.72 to 1.89). Carers in the intervention group reported less abusive behaviour towards the recipient of care compared with those in the treatment as usual group (odds ratio 0.47, 95% confidence interval 0.18 to 1.23), although this was not significant. CONCLUSIONS A manual based coping strategy was effective in reducing affective symptoms and case level depression in carers of family members with dementia. The carers' quality of life also improved. TRIAL REGISTRATION Current Controlled Trials ISCTRN70017938.