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.

Objectives:

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).

Design:

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).

Setting:

Participants were recruited through Memory Clinics and Community Mental Health Teams for older people.

Participants:

A total of 356 caregiving dyads were recruited and 273 completed the trial.

Intervention:

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.

Main outcome measures:

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.

Trial registration:

Current Controlled Trials ISRCTN65945963.

Funding:

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.

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 08/116/06. The contractual start date was in July 2010. The draft report began editorial review in October 2014 and was accepted for publication in April 2015. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Dr Aimee Spector reports personal fees from NHS trusts, outside the submitted work. Professor Alistair Burns reports personal fees from the International Journal of Geriatric Psychiatry, personal fees from NHS England, non-financial support from King’s College London and non-financial support from the Driver and Vehicle Licensing Agency, outside the submitted work. Professor Robert Woods reports royalties for group cognitive stimulation therapy manuals paid to Dementia Services Development Centre Wales, Bangor University (Hawker Publication and Freiberg Press, USA) outside the submitted work. Professor Ian Russell reports grants from University College London, both for the submitted work and outside the submitted work. Lauren Yates, Professor Martin Orrell, Phuong Leung, Dr Aimee Spector, Professor Robert Woods and Dr Vasiliki Orgeta have a patent on the individual cognitive stimulation therapy manual.