Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
In the UK, over 700,000 older people have dementia. This leads to progressive intellectual deterioration, problems carrying out daily activities such as self-care, social isolation, and increasing difficulty interacting and communicating. Dementia also has an immense social and economic impact on health and social care services, and on family carers. Drug treatments have an important role in dementia care but in the UK they are limited to people with Alzheimer's disease with moderately severe dementia, have a limited impact on the illness, and are not suitable for all patients. Psychological treatments for dementia such as reality orientation are widely used in the UK and internationally for several decades, but there has been little high quality research on their effectiveness. There is an urgent need to find useful interventions to help reduce the impact of dementia on people with dementia, carers and society. In the UK there is increasing recognition that psychological therapies for dementia should be made more available and the National Institute of Clinical Excellence has recommended that cognitive stimulation approaches should be made widely available for people with mild to moderate dementia. A new approach known as Cognitive Stimulation Therapy (CST) has been developed and has been found to improve memory, quality of life, and cognition. CST may also potentially reduce costs of care, for example by delaying institutionalisation. We have spoken to people with dementia and their carers who are keen on having a version of CST which can be delivered by the carer, particularly for people who are unable or unwilling to go out of the house and/or to attend groups. They also felt it could help the relationship between the carer and the person with dementia. Previous research has also shown that involving carers in delivering interventions can be beneficial for both. The aim of this study is to find out whether individual home-based CST improves cognition and quality of life in people with dementia.

Who can participate?
Patients with dementia

What does the study involve?
Participants are randomly allocated to receive either usual care or individual CST sessions delivered by their caregiver. Individual CST sessions last for 30 minutes each and take place three times a week over 25 weeks. We then assess cognition, quality of life, and costs of care in both groups.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University College London (UCL) (UK)

When is the study starting and how long is it expected to run for?
July 2010 to June 2014

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof Martin Orrell

Trial website

Contact information



Primary contact

Prof Martin Orrell


Contact details

Department of Mental Health Sciences
Charles Bell House
67-73 Riding House Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 08/116/06

Study information

Scientific title

Individual Cognitive Stimulation Therapy vs treatment as usual for dementia: a multicentre, single-blind, randomised controlled trial



Study hypothesis

1. Individual home-based CST (iCST) will benefit cognition and quality of life in people with dementia over six months relative to a control (treatment as usual) group
2. iCST will be cost-effective relative to treatment as usual

Ethics approval

Not provided at time of registration

Study design

Multicentre pragmatic single-blind two-arm randomised controlled clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact information to request a patient information




Individualised CST vs no treatment (control)
iCST sessions will last for 30 minutes and take place 3 times a week for 25 weeks.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog) (Rosen et al., 1984)
2. Quality of Life-Alzheimer's disease Scale (QoL-AD) (Logsdon et al., 1999)
3. Short Form-12 (SF-12) (Ware, Kosinski, and Keller, 1996)
Assessments will take place at baseline (pre iCST), 13 weeks (to safeguard loss to follow-up) and 26 weeks.

Secondary outcome measures

1. Client Service Receipt Inventory (Beecham & Knapp, 1992)
2. Dementia-related Quality of Life (DEMQOL) (Smith et al., 2005)
3. Behaviour
4. Neuropsychiatric Inventory (NPI) (Cummings et al. 1994)
5. Bristol Activities of Daily Living Scale (BADLS) (Bucks et al, 1996)
6. Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983)
7. EQ-5D (EuroQol group, 1990)
Assessments will take place at baseline, 13 and 26 weeks.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Meet Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM IV) criteria for dementia
2. Score 10 or above on the Mini Mental State Examination (MMSE)
3. Some ability to communicate and understand
4. See/hear well enough to participate
5. No major physical illness or disability affecting their participation
6. Male or female, no age restrictions

Additional criteria will include living in the community and regular availability of a carer (or friend or befriender) to participate in the sessions.

Participant type


Age group




Target number of participants


Participant exclusion criteria

People with dementia not meeting the criteria for individual work (living in a care home, no available family carer) but who are eligible for group CST will be linked up with the trial of maintenance group CST (NIHR programme).

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London (UCL) (UK)
United Kingdom

Sponsor information


University College London (UCL) (UK)

Sponsor details

Gower Street
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2012 protocol in:
2015 results in:
2015 results in:
2017 results in:

Publication citations

Additional files

Editorial Notes

30/03/2017: Publication reference added. 20/04/2016: Plain English summary added. 19/04/2016: Publication reference added.