title: 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.
abstract: BACKGROUND
  Two-thirds of people with dementia live at home, receiving most care from family carers, about 40% of whom have clinically significant depression or anxiety. This impacts on the person with dementia, families and society, predicting care breakdown. There are currently no clinically effective and cost-effective NHS family carer interventions.
  
  
  OBJECTIVE
  To assess the STrAtegies for RelaTives (START) intervention in the short (4 and 8 months) and long term (1 and 2 years) compared with treatment as usual (TAU).
  
  
  METHODS
  Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2:1 (intervention to TAU) to allow for therapist clustering.
  
  
  METHODS
  Three UK mental health services and one neurological service.
  
  
  METHODS
  Family carers of people with dementia.
  
  
  METHODS
  Eight-session manual-based coping intervention delivered by supervised psychology graduates to individuals.
  
  
  METHODS
  Affective symptoms [Hospital Anxiety and Depression Scale-total (HADS-T)] and cost-effectiveness. Secondary measures: anxiety and depression symptoms and caseness, quality of life (QoL), abusive behaviour and long-term care home admission.
  
  
  RESULTS
  Two hundred and sixty participants were randomised (173 intervention, 87 TAU). We used intention-to-treat analysis in the short term (152 intervention, 77 TAU) and in the long term (140 intervention, 69 TAU). In the short term, the intervention group had lower HADS-T [mean difference -1.80, 95% confidence interval (CI) -3.29 to -0.31; p=0.02] and higher quality-adjusted life-years (QALYs) (mean difference 0.03, 95% CI -0.01 to 0.08). Costs were no different between groups [mean £ 252 (95% CI -£ 28 to £ 565) for intervention group]. The cost-effectiveness acceptability curve showed a greater than 99% chance of being cost-effectiveness at a £ 30,000/QALY willingness-to-pay threshold and a high probability of cost-effectiveness based on the HADS-T score. Carers in the intervention group had less case-level depression [odds ratio (OR) 0.24, 95% CI 0.07 to 0.76], a trend towards reduced case-level anxiety (OR 0.30, 95% CI 0.08 to 1.05), lower Hospital Anxiety and Depression Scale-anxiety (HADS-A) (-0.91, 95% CI -1.76 to -0.07; p = 0.03) and Hospital Anxiety and Depression Scale-depression (HADS-D) (-0.91, 95% CI -1.71 to -0.10; p = 0.03) and higher Health Status Questionnaire (HSQ) QoL (mean difference 4.09, 95% CI 0.34 to 7.83). Group differences in abusive behaviour (OR 0.48, 95% CI 0.18 to 1.27) and the person with dementia's quality of life-Alzheimer's disease (QoL-AD) (mean increase 0.59, 95% CI -0.72 to 1.89) were not significant. In the long term, the intervention group had lower HADS-T (mean difference -2.58, 95% CI -4.26 to -0.90; p = 0.03) and higher QALYs (mean difference 0.03, 95% CI -0.01 to 0.06). Carers in the intervention group had less case-level depression (OR 0.14, 95% CI 0.04 to 0.53), a trend towards reduced case-level anxiety (OR 0.57, 95% CI 0.26 to 1.24), lower HADS-A (-1.16, 95% CI -2.15 to -0.18) and HADS-D (1.45, 95% CI -2.32 to -0.57), and higher HSQ (mean difference 7.47, 95% CI 2.87 to 12.08). Thirty-two (18.7%) people with dementia in the intervention group and 17 (20.2%) in TAU were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56; p = 0.56). There were no significant differences between groups in abusive behaviour (OR 0.83, 95% CI 0.36 to 1.94), the person with dementia's QoL-AD (0.17, 95% CI -1.37 to 1.70) or costs (£ 336, 95% CI -£ 223 to £ 895) for intervention group. The probability that the intervention would be seen as cost-effective at £ 30,000/QALY threshold and cost-effectiveness on the HADS-T remained high.
  
  
  CONCLUSIONS
  The START intervention was clinically effective and cost-effective in the short and longer term. The results are robust to the sensitivity analyses performed. Future work is needed to consider mechanism of action; the effects on people with dementia in clinical terms (cognition, neuropsychiatric symptoms, longer-term care home admission); and on health and social care costs. In addition, we will explore the effects of carer abusive behaviour on the care recipient's care home admission and if this then reduces abusive behaviour. We would also like to implement START and evaluate this implementation in clinical practice.
  
  
  BACKGROUND
  Current Controlled Trials ISCTRN70017938.
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Gill
authors.initials: G
authors.lastname: Livingston
authors.affiliation: Department of 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: Division of Psychiatry, University College London, London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Griffin
authors.affiliation: Institute of Psychiatry, King's College London, London, UK.
authors.forename: Renee
authors.initials: R
authors.lastname: Romeo
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: Division of Psychiatry, University College London, London, UK.
authors.forename: Debbie
authors.initials: D
authors.lastname: Livingston
authors.affiliation: Division of Psychiatry, University College London, London, UK.
authors.forename: Elanor
authors.initials: E
authors.lastname: Lewis-Holmes
authors.affiliation: Queen Square, University College London Hospitals NHS Foundation Trust, London, UK.
authors.forename: Cath
authors.initials: C
authors.lastname: Mummery
authors.affiliation: Division of Psychiatry, University College London, London, 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.
authors.forename: Claudia
authors.initials: C
authors.lastname: Cooper
mesh_terms: D000223:Adaptation, Psychological; D000368:Aged; D000369:Aged, 80 and over; D001008:Anxiety Disorders / Q000191:economics / Q000209:etiology / Q000628:therapy*; D017028:Caregivers / Q000191:economics / Q000523:psychology*; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000191:economics / Q000628:therapy*; D003866:Depressive Disorder / Q000191:economics / Q000209:etiology / Q000628:therapy*; D005190:Family / Q000523:psychology*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011613:Psychotherapy / Q000191:economics / Q000379:methods*; D019057:Quality-Adjusted Life Years; D012044:Regression Analysis; D013222:State Medicine / Q000191:economics; D006113:United Kingdom