title: Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial.
abstract: BACKGROUND
  Group cognitive stimulation therapy programmes can benefit cognition and quality of life for people with dementia. Evidence for home-based, carer-led cognitive stimulation interventions is limited.
  
  
  OBJECTIVE
  To evaluate the clinical effectiveness and cost-effectiveness of carer-delivered individual cognitive stimulation therapy (iCST) for people with dementia and their family carers, compared with treatment as usual (TAU).
  
  
  METHODS
  A multicentre, single-blind, randomised controlled trial assessing clinical effectiveness and cost-effectiveness. Assessments were at baseline, 13 weeks and 26 weeks (primary end point).
  
  
  METHODS
  Participants were recruited through Memory Clinics and Community Mental Health Teams for older people.
  
  
  METHODS
  A total of 356 caregiving dyads were recruited and 273 completed the trial.
  
  
  METHODS
  iCST consisted of structured cognitive stimulation sessions for people with dementia, completed up to three times weekly over 25 weeks. Family carers were supported to deliver the sessions at home.
  
  
  METHODS
  Primary outcomes for the person with dementia were cognition and quality of life. Secondary outcomes included behavioural and psychological symptoms, activities of daily living, depressive symptoms and relationship quality. The primary outcome for the family carers was mental/physical health (Short Form questionnaire-12 items). Health-related quality of life (European Quality of Life-5 Dimensions), mood symptoms, resilience and relationship quality comprised the secondary outcomes. Costs were estimated from health and social care and societal perspectives.
  
  
  RESULTS
  There were no differences in any of the primary outcomes for people with dementia between intervention and TAU [cognition: mean difference -0.55, 95% confidence interval (CI) -2.00 to 0.90; p-value = 0.45; self-reported quality of life: mean difference -0.02, 95% CI -1.22 to 0.82; p-value = 0.97 at the 6-month follow-up]. iCST did not improve mental/physical health for carers. People with dementia in the iCST group experienced better relationship quality with their carer, but there was no evidence that iCST improved their activities of daily living, depression or behavioural and psychological symptoms. iCST seemed to improve health-related quality of life for carers but did not benefit carers' resilience or their relationship quality with their relative. Carers conducting more sessions had fewer depressive symptoms. Qualitative data suggested that people with dementia and their carers experienced better communication owing to iCST. Adjusted mean costs were not significantly different between the groups. From the societal perspective, both health gains and cost savings were observed.
  
  
  CONCLUSIONS
  iCST did not improve cognition or quality of life for people with dementia, or carers' physical and mental health. Costs of the intervention were offset by some reductions in social care and other services. Although there was some evidence of improvement in terms of the caregiving relationship and carers' health-related quality of life, iCST does not appear to deliver clinical benefits for cognition and quality of life for people with dementia. Most people received fewer than the recommended number of iCST sessions. Further research is needed to ascertain the clinical effectiveness of carer-led cognitive stimulation interventions for people with dementia.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN65945963.
  
  
  BACKGROUND
  This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 19, No. 64. See the NIHR Journals Library website for further information.
authors: Division of Psychiatry, University College London, London, UK.
authors: Vasiliki
authors: V
authors: Orgeta
authors: Division of Psychiatry, University College London, London, UK.
authors: Phuong
authors: P
authors: Leung
authors: Division of Psychiatry, University College London, London, UK.|School of Medicine, Institute of Mental Health, Nottingham, UK.
authors: Lauren
authors: L
authors: Yates
authors: North Wales Organisation for Randomised Trials in Health, Institute of Medical and Social Care Research, Bangor, UK.
authors: Sujin
authors: S
authors: Kang
authors: North Wales Organisation for Randomised Trials in Health, Institute of Medical and Social Care Research, Bangor, UK.
authors: Zoe
authors: Z
authors: Hoare
authors: Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
authors: Catherine
authors: C
authors: Henderson
authors: North Wales Organisation for Randomised Trials in Health, Institute of Medical and Social Care Research, Bangor, UK.
authors: Chris
authors: C
authors: Whitaker
authors: Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.
authors: Alistair
authors: A
authors: Burns
authors: Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.
authors: Martin
authors: M
authors: Knapp
authors: Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.
authors: Iracema
authors: I
authors: Leroi
authors: Institute of Rehabilitation, University of Hull, Hull, UK.
authors: Esme D
authors: ED
authors: Moniz-Cook
authors: Devon Partnership NHS Trust, Exeter, UK.
authors: Stephen
authors: S
authors: Pearson
authors: Dorset Healthcare University NHS Foundation Trust, Dorset, UK.
authors: Stephen
authors: S
authors: Simpson
authors: Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.
authors: Aimee
authors: A
authors: Spector
authors: Lincolnshire Partnership NHS Foundation Trust, Lincoln, UK.
authors: Steven
authors: S
authors: Roberts
authors: College of Medicine, Swansea University, Swansea, UK.
authors: Ian T
authors: IT
authors: Russell
authors: Norfolk and Suffolk NHS Foundation Trust, Norwich, UK.|South London and Maudsley NHS Foundation Trust, Health Innovation Network South London, London, UK.
authors: Hugo
authors: H
authors: de Waal
authors: Dementia Services Development Centre Wales, Bangor University, Bangor, UK.
authors: Robert T
authors: RT
authors: Woods
authors: School of Medicine, Institute of Mental Health, Nottingham, UK.
authors: Martin
authors: M
authors: Orrell
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000523:psychology; D017028:Caregivers / Q000523:psychology*; D015928:Cognitive Behavioral Therapy / Q000191:economics* / Q000379:methods*; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000523:psychology* / Q000628:therapy*; D003863:Depression / Q000523:psychology; D004739:England; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008603:Mental Health; D011788:Quality of Life; D019057:Quality-Adjusted Life Years