Individual Cognitive Stimulation Therapy for dementia
| ISRCTN | ISRCTN65945963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65945963 |
| Protocol serial number | HTA 08/116/06 |
| Sponsor | University College London (UCL) (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 30/04/2010
- Registration date
- 05/05/2010
- Last edited
- 30/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
m.orrell@ucl.ac.uk
Contact information
Scientific
Department of Mental Health Sciences
UCL
Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
| m.orrell@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre pragmatic single-blind two-arm randomised controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Individual Cognitive Stimulation Therapy vs treatment as usual for dementia: a multicentre, single-blind, randomised controlled trial |
| Study acronym | iCST |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | 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 | Other |
| Primary outcome measure(s) |
1. Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog) (Rosen et al., 1984) |
| Key secondary outcome measure(s) |
1. Client Service Receipt Inventory (Beecham & Knapp, 1992) |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 306 |
| Key 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. |
| Key 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). |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
W1W 7EJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/02/2015 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No | |
| Results article | results | 28/03/2017 | Yes | No | |
| Protocol article | protocol | 22/09/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/03/2017: Publication reference added.
20/04/2016: Plain English summary added.
19/04/2016: Publication reference added.
