title: Long-term clinical and cost-effectiveness of psychological intervention for family carers of people with dementia: a single-blind, randomised, controlled trial.
abstract: 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 effectiveness (long-term reduction of depression and anxiety symptoms in family carers) and cost-effectiveness 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-identified 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 affective symptoms (Hospital Anxiety and Depression Scale total score [HADS-T]) 2 years after randomisation and cost-effectiveness (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.
  
  
  RESULTS
  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 efficacy analysis (140 START, 69 TAU). At 24 months, compared with TAU the START group was significantly better for HADS-T (mean difference -2·58 points, 95% CI -4·26 to -0·90; p=0·003). The intervention is cost effective for both carers and patients (67% probability of cost-effectiveness at the £20 000 per QALY willingness-to-pay threshold, and 70% at the £30 000 threshold).
  
  
  CONCLUSIONS
  START is clinically effective, improving carer mood and anxiety levels for 2 years. Carers in the control TAU group were seven times more likely to have clinically significant depression than those receiving START. START is cost effective 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.
  
  
  BACKGROUND
  National Institute for Health Research Health Technology Assessment programme 08/14/06.
authors.affiliation: Division of Psychiatry, University College London, London, UK; Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, UK. Electronic address: g.livingston@ucl.ac.uk.
authors.forename: Gill
authors.initials: G
authors.lastname: Livingston
authors.affiliation: Statistical Science and PRIMENT Clinical Trials Unit, University College London, London, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Barber
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Penny
authors.initials: P
authors.lastname: Rapaport
authors.affiliation: Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Knapp
authors.affiliation: Statistical Science and PRIMENT Clinical Trials Unit, University College London, London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Griffin
authors.affiliation: Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
authors.forename: Derek
authors.initials: D
authors.lastname: King
authors.affiliation: Institute of Psychiatry, King's College London, London, UK.
authors.forename: Renee
authors.initials: R
authors.lastname: Romeo
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Debbie
authors.initials: D
authors.lastname: Livingston
authors.affiliation: Institute of Neurology, University College London, London, UK.
authors.forename: Cath
authors.initials: C
authors.lastname: Mummery
authors.affiliation: Division of Psychiatry, University College London, London, UK; North Essex Partnership University NHS Foundation Trust, Chelmsford, UK.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Walker
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Juanita
authors.initials: J
authors.lastname: Hoe
authors.affiliation: Division of Psychiatry, University College London, London, UK; Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, UK.
authors.forename: Claudia
authors.initials: C
authors.lastname: Cooper