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Maintenance Cognitive Stimulation Therapy groups for dementia
ISRCTN ISRCTN26286067
DOI 10.1186/ISRCTN26286067
ClinicalTrials.gov identifier
EudraCT number
Public title Maintenance Cognitive Stimulation Therapy groups for dementia
Scientific title A multicentre randomised control trial of Maintenance Cognitive Stimulation Therapy (CST) vs CST only for dementia
Acronym MCST, SHIELD
Serial number at source RP-PG-0606-1083
Study hypothesis Maintenance Cognitive Stimulation Therapy (CST) groups for dementia will be more effective in the long-term than CST only groups.
Lay summary Lay summary under review 2
Ethics approval Barking and Havering Research Ethics Committee, approved on 14/10/2008 (ref: 08/H0702/68)
Study design Multicentre, single-blind, randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Dementia
Participants - 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
Participants - exclusion criteria Participants not meeting the inclusion criteria
Anticipated start date 01/11/2008
Anticipated end date 01/11/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 230
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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)
Sources of funding National Institute for Health Research (NIHR) (UK) (ref: RP-PG-0606-1083)
Trial website
Publications 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20426866
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24628705
Contact name Prof  Martin  Orrell
  Address University College London
Department of Mental Health Sciences
Bloomsbury Campus
67-73 Riding House Street
2nd Floor
Charles Bell House
  City/town London
  Zip/Postcode W1W 7EJ
  Country United Kingdom
Sponsor National Institute for Health Research (NIHR) (UK)
  Address Room 132
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Sponsor website: http://www.nihr.ac.uk
Date applied 26/08/2008
Last edited 10/10/2014
Date ISRCTN assigned 12/11/2008
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