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

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

Trial website

Contact information



Primary contact

Prof Martin Orrell


Contact details

University College London
Department of Mental Health Sciences
Bloomsbury Campus
67-73 Riding House Street
2nd Floor
Charles Bell House
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A multicentre randomised control trial of Maintenance Cognitive Stimulation Therapy (CST) vs CST only for dementia



Study hypothesis

Maintenance Cognitive Stimulation Therapy (CST) groups for dementia will be more effective in the long-term than CST only groups.

Ethics approval

Barking and Havering Research Ethics Committee, 14/10/2008, ref: 08/H0702/68

Study design

Multicentre single-blind randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




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 ( 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



Drug names

Primary 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. 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 trial start date


Overall trial end date


Reason abandoned


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 type


Age group




Target number of participants


Participant exclusion criteria

Participants not meeting the inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University College London
United Kingdom

Sponsor information


National Institute for Health Research (NIHR) (UK)

Sponsor details

Room 132
Richmond House
79 Whitehall
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) (ref: RP-PG-0606-1083)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

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

Results - basic reporting

Publication summary

2010 protocol in:
2014 results in:
2014 results in:
2015 economic evaluation in:

Publication citations

  1. Protocol

    Aguirre E, Spector A, Hoe J, Russell IT, Knapp M, Woods RT, Orrell M, Maintenance Cognitive Stimulation Therapy (CST) for dementia: a single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia., Trials, 2010, 11, 46, doi: 10.1186/1745-6215-11-46.

  2. Results

    Aguirre E, Hoare Z, Spector A, Woods RT, Orrell M, The effects of a Cognitive Stimulation Therapy [CST] programme for people with dementia on family caregivers' health., BMC Geriatr, 2014, 14, 31, doi: 10.1186/1471-2318-14-31.

  3. Results

    Orrell M, Aguirre E, Spector A, Hoare Z, Woods RT, Streater A, Donovan H, Hoe J, Knapp M, Whitaker C, Russell I, Maintenance cognitive stimulation therapy for dementia: single-blind, multicentre, pragmatic randomised controlled trial, Br J Psychiatry, 2014 , 204, 6, 454-461, doi: 10.1192/bjp.bp.113.137414.

  4. Economic evaluation

    D'Amico F, Rehill A, Knapp M, Aguirre E, Donovan H, Hoare Z, Hoe J, Russell I, Spector A, Streater A, Whitaker C, Woods RT, Orrell M, Maintenance cognitive stimulation therapy: an economic evaluation within a randomized controlled trial, J Am Med Dir Assoc, 2015 , 16, 1, 63-70, doi: 10.1016/j.jamda.2014.10.020.

Additional files

Editorial Notes

16/05/2016: Publication reference added.