Background Two-thirds of people with dementia live at home supported mainly by family carers. These carers
frequently develop clinical depression or anxiety, which predicts care breakdown. We aimed to assess the clinical
eff ectiveness (long-term reduction of depression and anxiety symptoms in family carers) and cost-eff ectiveness of a
psychological intervention called START (STrAtegies for RelaTives).
Methods We did a randomised, parallel-group trial with masked outcome assessments in three UK mental-health
services and one neurological-outpatient dementia service. We included self-identifi ed family carers of people with
dementia who had been referred in the previous year and gave support at least once per week to the person with
dementia. We randomly assigned these carers, via an online computer-generated randomisation system from an
independent clinical trials unit, to either START, an 8-session, manual-based coping intervention delivered by
supervised psychology graduates, or treatment as usual (TAU). The primary long-term outcomes were aff ective
symptoms (Hospital Anxiety and Depression Scale total score [HADS-T]) 2 years after randomisation and costeff ectiveness (health and social care perspectives) over 24 months. Analysis was by intention to treat, excluding
carers with data missing at both 12 and 24 months. This trial is registered ISCTRN70017938.
Findings From November 4, 2009, to June 8, 2011, we recruited 260 carers. 173 carers were randomly assigned to
START and 87 to TAU. Of these 260 participants, 209 (80%) were included in the clinical effi cacy analysis
(140 START, 69 TAU). At 24 months, compared with TAU the START group was signifi cantly better for HADS-T
(mean diff erence –2·58 points, 95% CI –4·26 to –0·90; p=0·003). The intervention is cost eff ective for both carers
and patients (67% probability of cost-eff ectiveness at the £20 000 per QALY willingness-to-pay threshold, and 70%
at the £30 000 threshold).
Interpretation START is clinically eff ective, improving carer mood and anxiety levels for 2 years. Carers in the
control TAU group were seven times more likely to have clinically signifi cant depression than those receiving
START. START is cost eff ective with respect to carer and patient outcomes, and National Institute for Health and
Care Excellence (NICE) thresholds. The number of people with dementia is rapidly growing, and policy
frameworks assume that their families will remain the frontline providers of (unpaid) support. This cost-neutral
intervention, which substantially improves family-carers’ mental health and quality of life, should therefore be
widely available.