Maintenance Cognitive Stimulation Therapy groups for dementia
| ISRCTN | ISRCTN26286067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26286067 |
| Secondary identifying numbers | RP-PG-0606-1083 |
- Submission date
- 26/08/2008
- Registration date
- 12/11/2008
- Last edited
- 13/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Background and study aims
The population is rapidly ageing and with this syndromes such as dementia are on the increase. The symptoms of dementia include memory loss and difficulties with thinking, problem-solving and language. Treatments such as Cognitive Stimulation Therapy (CST) have been developed to help people with dementia. CST is a 45-minute group therapy running twice weekly over 7 weeks that has been shown to improve cognition and quality of life for people with mild to moderate dementia. The aim of this study is to see whether an additional 24 weeks of maintenance CST sessions improves cognition in people with dementia .
Who can participate?
Patients with mild to moderate dementia
What does the study involve?
All participants will receive the initial CST programme consisting of 14, 45-minute twice weekly sessions. Participants will then be randomly allocated either to receive treatment as usual for 24 weeks or to attend weekly maintenance CST sessions for 24 weeks.
What are the potential benefits and risks of participating?
Reported benefits include feelings of validation, self worth and overall enjoyment of the sessions. There are no known risks to participants.
Where is the study run?
The study will take place in a variety of dementia care settings and NHS Trusts in the UK
When is the study starting and how long is it expected to run for?
Participants have been in the study since August 2011 and recruitment is expected to continue up until July 2012. Follow-up examinations will continue until July 2013.
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Amy Streater
a.streater@ucl.ac.uk
Contact information
Prof Martin Orrell
Scientific
Scientific
University College London
Department of Mental Health Sciences
Bloomsbury Campus
67-73 Riding House Street
2nd Floor
Charles Bell House
London
W1W 7EJ
United Kingdom
Study information
| Study design | Multicentre single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A multicentre randomised control trial of Maintenance Cognitive Stimulation Therapy (CST) vs CST only for dementia |
| Study acronym | MCST, SHIELD |
| Study hypothesis | Maintenance Cognitive Stimulation Therapy (CST) groups for dementia will be more effective in the long-term than CST only groups. |
| Ethics approval(s) | Barking and Havering Research Ethics Committee, 14/10/2008, ref: 08/H0702/68 |
| Condition | Dementia |
| Intervention | Although the first phase of the trial consists of identifying people with dementia that are taking cholinesterase inhibitors and the potential candidates suitable for taking cholinesterase inhibitor, only part of the trial consists of referring people to the appropriate health care teams in order to prescribe and monitor the medication. This randomised control trial is not a drug trial therefore all clinical responsibilities remain within the clinical team in charge of prescribing and monitoring medication. All participants received the initial CST programme. The CST programme aims to create an environment where people learn and strengthen their existing resources, hence functioning at their maximum capacity. This is achieved through implicit learning rather than explicit teaching. For example, people are asked of their opinions rather than to provide factual answers; and multi-sensory stimulation is used to stimulate all the senses. Reminiscence is integrated into the programme, partly used as a means to orientate to the here and now. The programme consisted of 14, 45-minute sessions which ran twice weekly for groups of approximately 5 people. Topics of the 14 sessions are as follows: 1. Physical games 2. Sound 3. Childhood 4. Food 5. Current affairs 6. Faces/scenes 7. Word association 8. Being creative 9. Categorising objects 10. Orientation 11. Using money 12. Number games 13. Word games 14. Team quiz The programme included an 'RO board', displaying both personal and orientation information, including the group name (chosen by participants). The guiding principles of CST are the principles of person-centred care, treating people as unique individuals with their own personality and preferences. This is an essential aspect when delivering CST therapy for people with dementia. For this reason, group members are often assigned a role within the group, according to their interests and abilities. After completion of the initial CST programme participants will be randomised into either the CST only control group (treatment as usual for 24 weeks) or maintenance CST group (Maintenance CST weekly for 24 weeks). The original maintenance CST of 16 sessions described in the pilot study (http://www.ncbi.nlm.nih.gov/pubmed/15852436) will be revised and further developed for this trial. The topics of the 16 sessions of the maintenance CST in the pilot study were as follows: 1. Childhood 2. Current affairs 3. Current affairs 4. Using objects 5. Number Games 6. Quiz 7. Music session 8. Physical games 9. Categorizing objects 10. Using objects 11. Useful tips 12. Discussion topics 13. Discussion topics 14. Discussion topics 15. Famous faces 16. Word completion The participants randomly allocated to the control group will receive treatment as usual and will naturally vary between and within centres and may change over time. In general, the interventions that could possibly been offered to this group will also be available to those in the active treatment groups, so that we will be examining the additional effects of maintenance CST. The only exception to this would be where the active treatment is scheduled at the same time as an alternative intervention. Our approach to costing the services and interventions received should allow us to monitor whether the usual treatment group is receiving alternative interventions in this way. Changes and developments in the availability of medications for Alzheimer's and other dementias will affect both groups equally, and will be recorded as part of the costing information collected. It is entirely feasible that participants in the usual treatment group may be involved in some form of cognitive stimulation work during the 24 weeks of the study period. It is a popular approach in day-care centres. However, it is very unlikely that, in our experience, such a structured approach to CST will be offered in any of the centres. It is this systematic group-based approach, rather than a general exhortation to cognitive stimulation activity to improve cognition and quality of life, that is the concern of this evaluation. |
| Intervention type | Behavioural |
| Primary outcome measure | The following will be assessed at baseline, after CST (7 weeks), after 3 and 6 months from the beginning of the maintenance sessions: 1. Cognition, assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) 2. Quality of Life: Alzheimer's disease Scale (QoL-AD), EQ-5D, Dementia Quality of Life (DemQol) |
| Secondary outcome measures | The following will be assessed at baseline, after CST (7 weeks), after 3 and 6 months from the beginning of the maintenance sessions: 1. Communication, assessed by the Holden Communication Scale 2. Severity of dementia, assessed by the Clinical Dementia Rating (CDR) 3. Depression, assessed by the Cornell Scale for Depression in Dementia 4. Anxiety, assessed by the Rating Anxiety in Dementia (RAID) tool 5. Behaviour, assessed by the Neuropsychiatric Inventory (NPI) 6. Activities of daily living, assessed by Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL) 7. Short Form-12 Health Survey (SF-12) |
| Overall study start date | 01/11/2008 |
| Overall study end date | 01/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 230 |
| Participant inclusion criteria | Both males and females are eligible, and there is no age limit for participation in this trial. People will be considered suitable for full assessment and participation if they: 1. Meet the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for dementia 2. Score between 0.5 and 2 on the Clinical Dementia Rating (CDR) 3. Have some ability to communicate and understand communication - a score of 1 or 0 in questions 12 and 13 of the Clifton Assessment Procedures for the Elderly - Behaviour Rating Scale (CAPE-BRS) 4. Are able to see and hear well enough to participate in the group and make use of most of the material in the programme, as determined by the researcher 5. Do not have major physical illness or disability which could affect participation 6. Do not have a diagnosis of a learning disability 7. Are able to communicate in English |
| Participant exclusion criteria | Participants not meeting the inclusion criteria |
| Recruitment start date | 01/08/2011 |
| Recruitment end date | 01/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
W1W 7EJ
United Kingdom
W1W 7EJ
United Kingdom
Sponsor information
National Institute for Health Research (NIHR) (UK)
Government
Government
Room 132
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.nihr.ac.uk |
|---|---|
"ROR" |
https://ror.org/0187kwz08 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) (ref: RP-PG-0606-1083)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/04/2010 | Yes | No | |
| Results article | results | 14/03/2014 | Yes | No | |
| Results article | results | 01/06/2014 | Yes | No | |
| Other publications | economic evaluation | 01/01/2015 | Yes | No | |
| Other publications | cost effectiveness analysis | 01/05/2019 | Yes | No |
Editorial Notes
13/03/2018: Publication reference added.
16/05/2016: Publication reference added.
