title: Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Improving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer.
  
  
  METHODS
  This multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks.For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective.
  
  
  CONCLUSIONS
  The UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.
authors.affiliation: Mental Health Sciences Unit, University College, London, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Orrell
authors.forename: Lauren A
authors.initials: LA
authors.lastname: Yates
authors.forename: Alistair
authors.initials: A
authors.lastname: Burns
authors.forename: Ian
authors.initials: I
authors.lastname: Russell
authors.forename: Robert T
authors.initials: RT
authors.lastname: Woods
authors.forename: Zoe
authors.initials: Z
authors.lastname: Hoare
authors.forename: Esme
authors.initials: E
authors.lastname: Moniz-Cook
authors.forename: Catherine
authors.initials: C
authors.lastname: Henderson
authors.forename: Martin
authors.initials: M
authors.lastname: Knapp
authors.forename: Aimee
authors.initials: A
authors.lastname: Spector
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Orgeta
mesh_terms: D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003704:Dementia / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D010349:Patient Compliance; D011897:Random Allocation; D018401:Sample Size; D016037:Single-Blind Method