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Cognitive stimulation to improve cognitive functioning in

people with dementia (Review)

Woods B, Aguirre E, Spector AE, Orrell M

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2012, Issue 2

http://www.thecochranelibrary.com

Cognitive stimulation to improve cognitive functioning in people with dementia (Review)

Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Figure 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Figure 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Figure 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Figure 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Figure 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Figure 12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Figure 13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Figure 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Figure 15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Figure 16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Figure 17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

21DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

24AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

51DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analysis 1.1. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 1

Cognition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Analysis 1.2. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 2 MMSE. 55

Analysis 1.3. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 3 ADAS-

Cog. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Analysis 1.4. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 4 Other

cognitive measure: Information/Orientation. . . . . . . . . . . . . . . . . . . . . . . . 57


Comunication and social interaction. . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Analysis 1.6. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 6 Well-being

& Quality of Life. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Analysis 1.7. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 7 Mood: Self-

reported. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Analysis 1.8. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 8 Mood:

Staff-reported. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Analysis 1.9. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 9 ADL

scales. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62


Behaviour, general. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

iCognitive stimulation to improve cognitive functioning in people with dementia (Review)



Behaviour, problem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Analysis 1.12. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment, Outcome 12 Caregiver

outcome. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Analysis 2.1. Comparison 2 Cognitive stimulation versus no cognitive stimulation: follow-up, Outcome 1 Cognition. 66

Analysis 2.2. Comparison 2 Cognitive stimulation versus no cognitive stimulation: follow-up, Outcome 2 Well-being &

Quality of Life. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Analysis 2.3. Comparison 2 Cognitive stimulation versus no cognitive stimulation: follow-up, Outcome 3 Behaviour,

general. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Analysis 2.4. Comparison 2 Cognitive stimulation versus no cognitive stimulation: follow-up, Outcome 4 Behaviour,

problem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Analysis 2.5. Comparison 2 Cognitive stimulation versus no cognitive stimulation: follow-up, Outcome 5 Communication

and social interaction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

70APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

76HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

76CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

77DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

77SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

77NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

77INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iiCognitive stimulation to improve cognitive functioning in people with dementia (Review)


[Intervention Review]

Cognitive stimulation to improve cognitive functioning inpeople with dementia

Bob Woods1 , Elisa Aguirre2, Aimee E Spector3, Martin Orrell4

1Dementia Services Development Centre Wales, Bangor University, Bangor, UK. 2University College London, London, UK. 3Research

Department of Clinical, Educational and Health Psychology, University College, London, London, UK. 4Research Department of

Mental Health Sciences, University College London, London, UK

Contact address: Bob Woods, Dementia Services Development Centre Wales, Bangor University, 45 College Road, Bangor, Gwynedd,

LL57 2DG, UK. [email protected].

Editorial group: Cochrane Dementia and Cognitive Improvement Group.

Publication status and date: New, published in Issue 2, 2012.

Review content assessed as up-to-date: 6 December 2011.

Citation: Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia.

Cochrane Database of Systematic Reviews 2012, Issue 2. Art. No.: CD005562. DOI: 10.1002/14651858.CD005562.pub2.


A B S T R A C T

Background

Cognitive stimulation is an intervention for people with dementia which offers a range of enjoyable activities providing general

stimulation for thinking, concentration and memory usually in a social setting, such as a small group. Its roots can be traced back to

Reality Orientation (RO), which was developed in the late 1950s as a response to confusion and disorientation in older patients in

hospital units in the USA. RO emphasised the engagement of nursing assistants in a hopeful, therapeutic process but became associated

with a rigid, confrontational approach to people with dementia, leading to its use becoming less and less common.

Cognitive stimulation is often discussed in normal ageing as well as in dementia. This reflects a general view that lack of cognitive

activity hastens cognitive decline. With people with dementia, cognitive stimulation attempts to make use of the positive aspects of

RO whilst ensuring that the stimulation is implemented in a sensitive, respectful and person-centred manner.

There is often little consistency in the application and availability of psychological therapies in dementia services, so a systematic

review of the available evidence regarding cognitive stimulation is important in order to identify its effectiveness and to place practice

recommendations on a sound evidence base.

Objectives

To evaluate the effectiveness and impact of cognitive stimulation interventions aimed at improving cognition for people with dementia,

including any negative effects.

Search methods

The trials were identified from a search of the Cochrane Dementia and Cognitive Improvement Group Specialized Register, called ALOIS

(updated 6 December 2011). The search termsused were: cognitive stimulation, reality orientation, memory therapy, memory groups,

memory support, memory stimulation, global stimulation, cognitive psychostimulation. Supplementary searches were performed in a

number of major healthcare databases and trial registers to ensure that the search was up to date and comprehensive.

Selection criteria

All randomised controlled trials (RCTs) of cognitive stimulation for dementia which incorporated a measure of cognitive change were

included.

1Cognitive stimulation to improve cognitive functioning in people with dementia (Review)


mailto:[email protected]

http://www.medicine.ox.ac.uk/alois

Data collection and analysis

Data were extracted independently by two review authors using a previously tested data extraction form. Study authors were contacted

for data not provided in the papers. Two review authors conducted independent assessments of the risk of bias in included studies.

Main results

Fifteen RCTs were included in the review. Six of these had been included in the previous review of RO. The studies included participants

from a variety of settings, interventions that were of varying duration and intensity, and were from several different countries. The

quality of the studies was generally low by current standards but most had taken steps to ensure assessors were blind to treatment

allocation. Data were entered in the meta-analyses for 718 participants (407 receiving cognitive stimulation, 311 in control groups). The

primary analysis was on changes that were evident immediately at the end of the treatment period. A few studies provided data allowing

evaluation of whether any effects were subsequently maintained. A clear, consistent benefit on cognitive function was associated with

cognitive stimulation (standardised mean difference (SMD) 0.41, 95% CI 0.25 to 0.57). This remained evident at follow-up one to

three months after the end of treatment. In secondary analyses with smaller total sample sizes, benefits were also noted on self-reported

quality of life and well-being (standardised mean difference: 0.38 [95% CI: 0.11, 0.65]); and on staff ratings of communication and

social interaction (SMD 0.44, 95% CI 0.17 to 0.71). No differences in relation to mood (self-report or staff-rated), activities of daily

living, general behavioural function or problem behaviour were noted. In the few studies reporting family caregiver outcomes, no

differences were noted. Importantly, there was no indication of increased strain on family caregivers in the one study where they were

trained to deliver the intervention.

Authors’ conclusions

There was consistent evidence from multiple trials that cognitive stimulation programmes benefit cognition in people with mild to

moderate dementia over and above any medication effects. However, the trials were of variable quality with small sample sizes and

only limited details of the randomisation method were apparent in a number of the trials. Other outcomes need more exploration but

improvements in self-reported quality of life and well-being were promising. Further research should look into the potential benefits

of longer term cognitive stimulation programmes and their clinical significance.

P L A I N L A N G U A G E S U M M A R Y

Can cognitive stimulation benefit people with dementia?

People with dementia and their caregivers are often advised that ’mental exercise’ may be helpful in slowing down the decline in memory

and thinking experienced by many people with dementia. This review examined the evidence for one form of mental exercise, described

as cognitive stimulation. This involves a wide range of activities that aim to stimulate thinking and memory generally, including

discussion of past and present events and topics of interest, word games, puzzles, music and practical activities such as baking or indoor

gardening. Typically this is carried out by trained staff with a small group of four or five people with dementia for around 45 minutes

at least twice a week. Family caregivers have also been trained to provide cognitive stimulation to their relative on a one-to-one basis.

This review included 15 trials with a total of 718 participants. The findings suggested that cognitive stimulation has a beneficial effect

on the memory and thinking test scores of people with dementia. Although based on a smaller number of studies, there was evidence

that the people with dementia who took part reported improved quality of life. They were reported to communicate and interact better

than previously. No evidence was found of improvements in the mood of participants or their ability to care for themselves or function

independently, and there was no reduction in behaviour found difficult by staff or caregivers. Family caregivers, including those who

were trained to deliver the intervention, did not report increased levels of strain or burden.

The trials included people in the mild to moderate stages of dementia and the intervention does not appear to be appropriate for people

with severe dementia. More research is needed to find out how long the effects of cognitive stimulation last and for how long it is

beneficial to continue the stimulation. Involving family caregivers in the delivery of cognitive stimulation is an interesting development

and merits further evaluation.



B A C K G R O U N D

Interventions with a cognitive focus have long been used in de-

mentia care. They have been developed in parallel with approaches

emphasising the stimulation of the senses (Woods 1977). Reality

Orientation (RO) (Taulbee 1966) was developed in the late 1950s

as a response to confusion and disorientation in older patients in

hospital units in the USA, and was the prototype of the cognitive

stimulation approach. Classes were held for 30 minutes once or

twice per day. Basic personal and current information was pre-

sented to the patient and a variety of materials used, such as in-

dividual calendars, word-letter games, building blocks and large-

piece puzzles. A Reality Orientation board would be used in each

session and would list the name of the unit and its location, the

day, date, weather, current events etc. The approach emphasised

the engagement of nursing assistants in a hopeful, therapeutic pro-

cess.

The first controlled evaluation of RO was reported in the UK by

Brook et al (Brook 1975). They found positive benefits on ratings

of intellectual and social functioning in patients attending RO

group sessions for 30 minutes per day, five days per week for four

months compared with a control group who visited a special RO

room daily but were not given any encouragement to engage with

the materials or each other. A spate of controlled studies followed

(Holden 1995), with outcome measures typically including assess-

ments of orientation, other aspects of cognitive functioning and

level of independent functioning. A Cochrane review specifically

examining Reality Orientation (Spector 2000a; Spector 2000b)

concluded that there was some evidence that RO had benefits for

people with dementia on both cognition and behaviour. How-

ever, outside of a few countries (notably Italy), RO has been little

practised or researched since 1990 and has attracted some crit-

icism (Burton 1982; Dietch 1989; Powell-Proctor 1982), espe-

cially for being applied in a mechanical, inflexible, insensitive and

confrontational manner. Doubts were also raised about the clin-

ical significance of any improvements; the person with dementia

might now know what day of the week it was but would this have

any meaningful impact on the person’s life? Such was the concern

regarding the insensitive use of RO and other cognitive approaches

that one influential set of guidelines on the management of de-

mentia (APA 1997) cautioned against their use with the possibility

of a negative impact on the person’s well-being that outweighed

any small cognitive improvements.

In addition to the ’classroom’ element of RO, from the early days

’24 hour RO’ was also advocated. This involves staff taking every

opportunity to provide current information to the person, outside

of the formal setting of the RO group, as well as using environ-

mental features such as sign-posting and orientation boards to as-

sist orientation. There have been some positive evaluations of the

effects of training and sign-posting on orientation around a care

facility (for example Hanley 1981; McGilton 2003) but the effects

of 24 hour RO per se have been more difficult to evaluate. This

is not least of all because of the difficulty in monitoring its imple-

mentation, with informal interactions being much more difficult

to document than a formal group meeting. Williams 1987 reports

using a modified form of 24 hour RO where staff were trained to

respond appropriately to residents’ requests for information, and

found that 90% of staff responses to residents’ requests complied

with the treatment protocol. This study reported improvements

in cognition, independent functioning and orientation, compared

with a control group on a separate ward, when this form of 24

hour RO was implemented.

Alongside the RO literature, in recent years there has been increas-

ing discussion of ’cognitive stimulation’. In part this reflects a gen-

eral view that lack of cognitive activity hastens cognitive decline,

in normal ageing as well as in dementia (Breuil 1994; Small 2002),

and in part it is an attempt to make use of the positive aspects of

RO whilst ensuring that it is implemented in a properly sensitive

and respectful manner (Spector 2001; Woods 2002). There has

also been growing interest in the application of various forms of

cognitive training and in teaching individual people with demen-

tia to use memory aids and strategies to assist with their particular

difficulties that have been identified with the person. A Cochrane

review of cognitive training and cognitive rehabilitation in early

stage dementia has been completed (Clare 2003) and it is impor-

tant to ensure that clear definitions are used to avoid confusion

between the various cognition-based approaches, as in the past

’training’, ’stimulation’ and ’rehabilitation’ have been used almost

interchangeably.

Clare and Woods (Clare 2004) proposed the following definitions.

Cognitive stimulation is engagement in a range of activities and

discussions (usually in a group) aimed at general enhancement of

cognitive and social functioning.

Cognitive training is guided practice on a set of standard tasks

designed to reflect particular cognitive functions; a range of diffi-

culty levels may be available within the standard set of tasks to suit

the individual’s level of ability. It may be offered in individual or

group sessions, with pencil and paper or computerised exercises.

Cognitive rehabilitation is an individualised approach where per-

sonally relevant goals are identified and the therapist works with

the person and his or her family to devise strategies to address

these. The emphasis is on improving performance in everyday life

rather than on cognitive tests, building on the person’s strengths

and developing ways of compensating for impairments

Using these definitions, this review included studies on RO group

sessions but not on 24 hour RO or direct training in spatial orien-

tation. The primary outcomes examined will be in relation to the

person’s cognitive functioning. It is considered that this is the min-

imum expectation of a general approach with this focus. However,



given the concerns discussed above of a possible negative effect,

measures of quality of life, mood and well-being are highly per-

tinent secondary outcome measures. The effects on the person’s

general level of function in everyday life also need to be considered

in evaluating the meaning of any changes observed for the individ-

ual and his or her supporters. The impact on family caregivers and

careworkers is also important to consider as they are key partners

in the process of care.

O B J E C T I V E S

• To evaluate the effectiveness and impact of cognitive

stimulation interventions aimed at improving cognition for

people with dementia, including any negative effects.

• To indicate the nature and quality of the evidence available

on this topic.

• To assist in establishing the appropriateness of offering

cognitive stimulation interventions to people with dementia and

identifying the factors associated with their efficacy.

M E T H O D S

Criteria for considering studies for this review

Types of studies

This review focused on randomised controlled trials (RCTs) for

which adequate information was provided or could be obtained

from the researchers. The studies included must have been pub-

lished, written in English and presented in a peer-reviewed journal

article.

Types of participants

• Participants with a diagnosis of dementia. The main

diagnostic categories that were included were Alzheimer’s disease,

vascular dementia or mixed Alzheimer’s and vascular dementia.

These diagnostic categories were considered together. Older

studies, included from the previous review of RO, used other

terms for this population but were included where the review

authors were satisfied that the included population would now

be described as having a dementia. Participants with mild

cognitive impairment, where the extent of cognitive impairment

or its effects on day-to-day function were insufficient to justify a

dementia diagnosis, were not included.

• Severity of dementia was indicated through group mean

scores, range of scores, or individual scores on a standardised

scale such as the Mini-Mental State Examination (MMSE)

(Folstein 1975) or Clinical Dementia Rating (CDR) (Hughes

1982). All levels of severity were included.

• Qualifying participants received the intervention in a range

of settings, including their own home, as outpatients and in day-

care and residential settings.

• No specific restrictions regarding age were applied.

• Data from family caregivers were included where this was

available and where the relationship between the caregiver and

the person with dementia was specified, including whether they

were co-resident.

• The number of participants receiving concurrent treatment

with acetylcholinesterase inhibitors was documented, where

possible.

Types of interventions

• Studies were considered for this review if they described a

cognitive stimulation intervention targeting cognitive and social

functioning. These interventions may also have been described as

RO groups, sessions or classes.

• The definition of cognitive stimulation as proposed by

Clare 2004 was adopted. This meant that some studies which

described their intervention as ’cognitive stimulation’ were

excluded. Interventions needed to offer exposure to generalised

cognitive activities rather than training in a specific modality.

• Interventions were typically conducted in a group to

enhance social functioning, or could involve family caregivers.

• Studies were included if a comparison was made to ’no

treatment’, ’standard treatment’ or placebo. Standard treatment

was understood to be the treatment that was normally provided

to patients with dementia in the study setting and could include

provision of medication, clinic consultations, contact with a

community mental health team, day care, or support from

voluntary organisations. Placebo conditions could consist, for

example, of an equivalent number of sessions in which general

support, but no structured intervention, was offered.

• The minimum duration of intervention for inclusion of a

study was one month. There were no restrictions on the number

of treatment sessions, although this was noted.

Types of outcome measures

• Outcomes were considered in relation to the impact of the

intervention on the person with dementia and on the primary

family caregiver. Studies could present data in both these

categories.

• Short term (immediately after the intervention) and

medium term (follow-up one month to one year after the

intervention finished) outcomes were considered.

• Outcomes for the person with dementia and the caregiver

were considered where these were assessed using scores on

standardised tests, rating scales and questionnaires.



• Rates of attrition and reasons for participants dropping out

from the study were noted.

Outcomes for the person with dementia

Outcome measures for the person with dementia sought to identify

whether changes were observed following the intervention. The

following variables were considered as outcome measures for the

person with dementia.

• Performance on at least one test of cognitive functioning

(including tests of memory and orientation).

• Self-reported, clinically-rated or carer-reported measures for

mood of the person with dementia.

• Self-reported or carer-reported quality of life or well-being

measures for the person with dementia.

• Observer or carer ratings of everyday functioning (activities

of daily living) of the person with dementia.

• Carer ratings of the participant’s behaviour.

• Clinician or carer ratings of neuropsychiatric symptoms or

behaviour problems of the person with dementia.

• Clinician or carer ratings of the social engagement of the

person with dementia.

’Carer’ in this context included care staff as well as family care-

givers.

Outcomes for the family caregiver

The outcomes for the family caregiver that were considered in-

cluded any of the following.

• Self-reported well-being, depression and anxiety.

• Self-reported burden, strain and coping.

• Satisfaction with the intervention.

Search methods for identification of studies

We searched ALOIS (

www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cog-

nitive Improvement Group Specialized Register, on 6 December

2011. The search terms used were: cognitive stimulation, reality

orientation, memory therapy, memory groups, memory support,

memory stimulation, global stimulation, cognitive psychostimu-

lation.

ALOIS is maintained by the Trials Search Co-ordinator of the

Cochrane Dementia and Cognitive Improvement Group and con-

tains studies in the areas of dementia prevention, dementia treat-

ment and cognitive enhancement in healthy populations. The

studies are identified from:

1. monthly searches of a number of major healthcare

databases: MEDLINE, EMBASE, CINAHL, PsycINFO and

LILACS;

2. monthly searches of a number of trial registers: meta

Register of Controlled Trials; Umin Japan Trial Register; WHO

portal (which covers ClinicalTrials.gov; ISRCTN; Chinese

Clinical Trials Register; German Clinical Trials Register; Iranian

Registry of Clinical Trials and the Netherlands National Trials

Register, plus others);

3. quarterly search of the Cochrane Central Register of

Controlled Trials (CENTRAL) (The Cochrane Library);4. six-monthly searches of a number of grey literature sources:

ISI Web of Knowledge Conference Proceedings; Index to

Theses; Australasian Digital Theses.

To view a list of all sources searched for ALOIS see About ALOIS

on the ALOIS website.

Details of the search strategies used for the retrieval of reports of

trials from the healthcare databases, CENTRAL and conference

proceedings can be viewed in the ‘methods used in reviews’ sec-

tion within the editorial information about the Dementia and

Cognitive Improvement Group (CDCIG).

Additional searches in each of the sources listed above, to cover

the timeframe from the last searches performed for the Specialized

Register to December 2011, were run to ensure that the search for

the review was as up to date as possible. The search strategies used

can be seen in Appendix 1.

A total of 804 references were retrieved from the December 2011

search. After de-duplication and a first assessment, authors were

left with 41 references to further assess for either inclusion, exclu-

sion or discarding.

Data collection and analysis

Searches were conducted as detailed above to identify all relevant

published studies. The date and time of each search, together with

details of the version of the database used, were recorded. Addi-

tional information was sought, as outlined above, and hard copies

of articles were obtained.

Quality assessment

RCTs were identified and the two review authors (BW and EA)

worked independently to determine which studies met the criteria

for inclusion. Trials that did not meet the criteria were excluded,

and reasons for exclusion were noted in the table ’Characteristics

of excluded studies’. Review authors’ selections of trials were com-

pared and the final list of included studies was reached by consen-

sus.

The selected RCTs were described in tabular form, permitting an

evaluation of their methodological quality. Studies were assessed

against a checklist of quality requirements using the Cochrane

approach (see risk of bias tables).

• Grade A, ’Low risk’: adequate concealment (randomisation;

concealed allocation).





http://www.medicine.ox.ac.uk/alois/content/about-alois

http://www.medicine.ox.ac.uk/alois/content/about-alois

http://mrw.interscience.wiley.com/cochrane/clabout/articles/DEMENTIA/frame.html





• Grade B, ’Unclear risk’: “randomised”, but methods

uncertain.

• Grade C, ’High risk’: inadequate concealment of allocation

or no randomisation, or both.

Only trials with a grade A or B ranking were included in the re-

view. Again, the review authors worked independently to ascertain

which studies met the quality criteria, and consensus was reached

through discussion. Attempts were made to obtain additional in-

formation from the study authors when further data were needed.

Data extraction

Data from the RCTs selected for inclusion were extracted, recorded

and entered into RevMan. The summary statistics required for

each trial and each outcome for continuous data were the mean

change from baseline, the standard error of the mean change, and

the number of patients for each treatment group at each assess-

ment point. Where changes from baseline were not reported, the

review authors extracted the mean, standard deviation and the

number of patients for each treatment group at each time point,

if available. The review authors calculated the required summary

statistics from the baseline and post-treatment group means and

standard deviations, assuming in this case a zero correlation be-

tween the measurements at the baseline and follow-up time points.

This method overestimates the standard deviation of the change

from baseline but this conservative approach was chosen as it is

preferable in a meta-analysis. For binary data, the review authors

sought the numbers in each treatment group and the numbers

experiencing the outcome of interest. The baseline assessment was

defined as the latest available assessment prior to randomisation,

but no longer than two months prior.

For each outcome measure, data were sought on every patient

randomised. To allow an intention-to-treat analysis, the data were

sought irrespective of compliance and whether or not the patient

was subsequently deemed ineligible or otherwise excluded from

treatment or follow-up. If intention-to-treat data were not avail-

able in the publications, ’on-treatment’ data or the data of those

who completed the trial were sought and were indicated as such.

In studies where a cross-over design was used, only data from the

first treatment phase after randomisation were eligible for inclu-

sion.

As the outcomes measured in clinical trials of dementia and cog-

nitive impairment often arise from ordinal rating scales, where the

rating scales had a reasonably large number of categories (more

than 10) the data were treated as continuous outcomes arising

from a normal distribution.

Data analysis

The meta-analyses included the combination of data from trials

that may not use the same rating scale to assess an outcome. There-

fore, the measure of the treatment difference for any outcome used

was the weighted mean difference when the pooled trials used the

same rating scale or test and the standardised mean difference (the

absolute mean difference divided by the standard deviation) when

they used different rating scales or tests. The duration of the trials

may vary considerably. If the review authors considered the range

too great to combine all trials into one meta-analysis, they divided

it into smaller time periods and conducted a separate meta-analy-

sis for each period. Some trials may have contributed data to more

than one time period if multiple assessments were made.

The meta-analyses presented overall estimates of the treatment

difference from a fixed-effect model and a test for heterogeneity

was performed using a standard Chi2 statistic. Where there was

evidence of heterogeneity of the treatment effect between trials

then a random-effects model was utilised (which results in broader

confidence intervals than for those of a fixed-effect model).

The review authors discussed and reached consensus on the in-

terpretation of the statistical analyses, seeking specialist statistical

advice from CDCIG as required. The review authors discussed

and reached consensus on the presentation of the findings in the

background to the review.

R E S U L T S

Description of studies

See: Characteristics of included studies; Characteristics of

excluded studies; Characteristics of studies awaiting classification;

Characteristics of ongoing studies.

From the initial set of references identified by the updated sys-

tematic searches (since our last review, Spector 2000a), 53 po-

tentially relevant studies were identified. Of these, seven studies

met the inclusion criteria (Baldelli 2002; Bottino 2005; Chapman

2004; Onder 2005; Requena 2006; Spector 2001; Spector 2003)

and were included in this review. Our previous review (Spector

2000a) included eight studies in the meta-analysis, six of which

were included in this replacement review (Baines 1987; Baldelli

1993a; Breuil 1994; Ferrario 1991; Wallis 1983; Woods 1979).

For the two studies excluded at this stage, the data needed for the

current analyses were not available (Gerber 1991; Hanley 1981).

Full details of included studies and reasons for exclusion of ex-

cluded studies are presented in the tables ’Characteristics of in-

cluded studies’ and ’Characteristics of excluded studies’. The pre-

publication search in December 2011 identified 41 further stud-

ies for consideration. Two further studies (Buschert 2011; Coen

2011) met the inclusion criteria and have been added to the re-

view, with three further studies awaiting classification (Buettner

2011; Fernandez-Calvo 2010; Niu 2010).

Overall, 718 participants, 407 in the treatment groups and 311

in the control groups, were included in the analyses of the 15 in-

cluded studies. The included studies varied in many aspects: (1)



participant characteristics; (2) number and duration of cognitive

stimulation sessions; (3) activities which defined cognitive stim-

ulation; (4) the activity of the control group; and (5) outcome

measures. These factors will be considered in turn.

1) Participant characteristics

Diagnosis: eight of the nine new studies specified the diagnostic

criteria used. Coen 2011 simply described their participants as hav-

ing mild to moderate dementia; Spector 2001 and Spector 2003

used DSM-IV criteria, but did not break the participants down

by dementia subtype; Baldelli 2002 included similar numbers of

participants with “Degenerative senile dementia of the Alzheimer’s

type (SDAT)” (N = 46) and “vascular multi-infarct dementia”

(N = 41), although all had experienced at least one cerebrovascu-

lar accident resulting in motor deficits; Bottino 2005, Buschert

2011, Chapman 2004, Onder 2005 and Requena 2006 all speci-

fied a diagnosis of probable Alzheimer’s disease (AD) according to

NINCDS-ADRDA criteria linked with either ICD-10 or DSM-

IIIR criteria. In these studies, participants were on a stable dose

of an acetylcholinesterase inhibitor (ACHEI) (rivastigmine in the

Bottino 2005 study; donepezil in the remaining studies apart from

Buschert 2011 where a variety of medications including meman-

tine were being taken). Amongst the earlier studies, Breuil 1994

specified DSM-III criteria for dementia and Baldelli 1993a stated

that their participants were diagnosed with “Alzheimer’s (SDAT)

”. The four studies from 1991 and earlier specified more general

criteria using cognitive measures that indicated that dementia di-

agnoses were justifiable (Baines 1987; Ferrario 1991; Wallis 1983;

Woods 1979).

Ten of the 11 most recent studies provided mean baseline scores

on the Mini-Mental State Examination (MMSE), and the 11th

(Ferrario 1991) provided the MMSE score range for participants.

Coen 2011, Spector 2001 and Spector 2003 were the only studies

with a mean MMSE score in the moderate range (10 to 20), per-

haps reflecting the upper limit of 24 for participants to be included

in these studies. The mean scores (16.9, 13.1 and 14.4 respec-

tively) were several points lower than those in the eleven studies

reporting mean scores (mean average 19.7), and outside the range

of 18 to 25 specified by Ferrario 1991. However, those studies

where the mean score was in the mild range (> 20) may well have

included participants in the moderate or even the severe range, for

example the lowest score in the Breuil 1994 study was reported to

be 9. In general, however, it can be said that the studies included

in this review had targeted participants in the mild to moderate

range of cognitive impairment.

The average age of participants was over 70 years in all studies

(except Wallis 1983 where it was 69.8 years); in 6 studies it was

over 80 years. The average mean age across the 15 studies was

78.8 years, with the range of ages that were reported from 38 to

97 years. Over half the studies reported inclusion of participant(s)

aged 90 years and above.

Participants were resident in care homes, nursing homes or hospi-

tals, apart from six studies (Bottino 2005; Breuil 1994; Buschert

2011; Chapman 2004; Onder 2005; Requena 2006) where all the

participants were outpatients living in the community. The par-

ticipants included in the Spector 2001 and Spector 2003 studies

were recruited from both residential care homes and day centres,

with the former being in the majority.

2) Length, number and duration of sessions

The length of the intervention varied from four weeks (the min-

imum for inclusion in the review) to 24 months, with the stated

length of sessions varying from 30 minutes to 90 minutes. In

general, the sessions of longer duration were associated with the

lowest frequency (once a week). The median session length across

the studies was 45 minutes, and the median frequency was three

times a week, ranging from once to five times a week. The total

possible exposure to the intervention varied dramatically, from 10

to 12 hours (Baines 1987; Breuil 1994; Chapman 2004; Coen

2011; Spector 2001; Spector 2003) to 375 hours in the two-year

(Requena 2006) study. Across the 15 studies, the median exposure

time was 30 hours. Requena 2006 presented data from both the

12 month and 24 months time point in their study. As there was

less attrition at the 12 month time point, and this was more com-

parable (although still longer) in duration to the other studies, the

12 month data were used in combination with other studies in the

meta-analyses, with the 24 month data reported separately.

3) Activities during cognitive stimulation

The level of detail provided in the published papers regarding the

activities undertaken varied greatly. All studies used small group

sessions, typically with groups of five to seven participants, with

the exception of Onder 2005 where family caregivers were taught

to carry out cognitive stimulation with the person with dementia

on an individual basis. These individual sessions, led by family

caregivers, included current information, topics of general interest,

historical events and famous people, attention, memory and visuo-

spatial exercises and the use of clocks, calendars and notes.

Early studies described the use of an RO board and discus-

sion of current orientating information through newspapers, pho-

tographs, calendars and clocks etc., with materials selected to stim-

ulate all five senses (for example Baines 1987; Wallis 1983; Woods

1979). Breuil 1994 introduced a number of more specific cogni-

tive activities including drawing, associating words, object nam-

ing and categorising. Spector 2006 provided a detailed session by

session treatment manual for the approach used in their studies.

Activities in their sessions were designed with four themes: (1) the

senses, (2) remembering the past, (3) people and objects, and (4)

everyday practical issues. Activities included naming objects and

people, association of words, remembering the past, discussion of



hobbies, activities and current affairs, using money, knowing the

way around and orientation topics. This treatment manual was

also used by Coen 2011. Chapman 2004 reported topics includ-

ing current events, discussion of hobbies and activities, education

regarding Alzheimer’s disease, life story work, and links with daily

life with groups of six to seven participants. Bottino 2005 described

temporal and spatial orientation, discussion of interesting themes,

reminiscence activities, naming people, planning of daily activities

and use of calendars and clocks and other external memory aids.

Requena 2006 described, for groups of five people with dementia,

visual images being shown on a TV screen from a computer and

that reflected seven themes: orientation, bodily awareness, family

and society, caring for oneself, reminiscing, household activities,

animals, people and objects. These were accompanied by ques-

tions for discussion.

None of the included trials adopted 24 hour RO in addition to

group sessions, although Bottino 2005 described involving family

caregivers in encouraging the use of external memory aids at home,

Buschert 2011 described the use of exercises and tasks to be carried

out at home between sessions and Onder 2005 encouraged family

caregivers to informally engage in reality-based communication

with the person with dementia two or three times a day.

4) Control group(s) activities

In the earlier studies, alternative group activities were offered that

were of a social (Woods 1979) or diversional (Wallis 1983) na-

ture. Baines 1987 offered an alternative treatment, reminiscence

groups, but for the purposes of this review it was the no-treatment

group that was included in the analyses. ’Treatment as usual’ or

no treatment was the control condition in a number of studies

(Baldelli 1993a; Breuil 1994; Coen 2011; Ferrario 1991; Spector

2001; Spector 2003). In those studies where participants were also

taking ACHEIs, the control group were typically monitored in

relation to the medication (Chapman 2004; Bottino 2005; Onder

2005; Requena 2006). Requena 2006 reported that their control

participants watched TV whilst the cognitive stimulation groups

were in session. Baldelli 2002 engaged both the control and cog-

nitive stimulation participants in a physical therapy programme.

Buschert 2011 asked control participants to complete pencil and

paper tasks at home, encouraged by monthly group meetings.

5) Outcome measures

As a condition of inclusion, cognitive tests were used in all the

studies. Eleven studies used the MMSE (Folstein 1975) and eight

of the more recent studies also used the Alzheimer’s Disease As-

sessment Scale - Cognitive (ADAS-Cog) (Rosen 1984). Unfortu-

nately, only the 10 month follow-up data on these and other mea-

sures could be utilised from Chapman 2004 as it has not proved

possible to obtain their data at earlier time points in an extractable

form. Four studies used a self-report quality of life measure with

participants with dementia (Buschert 2011; Chapman 2004; Coen

2011; Spector 2003), but again the Chapman 2004 data was not

in a useable form. Five studies used a self-report depression mea-

sure (four making use of a version of the Geriatric Depression

Scale: Yesavage 1983), and four studies used a depression or anx-

iety scale completed from carer reports as well as from interviews

with the participants (such as the Cornell Scale for Depression in

Dementia: Alexopoulos 1988). A variety of scales have been used

to evaluate behaviour, with activities of daily living (ADL) scales

used in four studies, general behaviour ratings in seven studies

and problem behaviour scales used in three studies. Family care-

giver outcome measures were used in three studies (Bottino 2005;

Onder 2005; Spector 2001).

A full list of the outcome measures used in the included studies

can be found in the table Characteristics of included studies’.

Risk of bias in included studies

Details for each study are provided in the ’Characteristics of in-

cluded studies’ table.

Allocation

For a study to be included in this review, the review authors had

to be satisfied that random allocation to treatment conditions had

been used. To ascertain this, in several cases it was necessary to seek

further information from the study authors (for example Baldelli

1993a; Baldelli 2002; Ferrario 1991; Requena 2006). Remote or

computerised randomisation was only used in four of the most

recent studies (Bottino 2005; Chapman 2004; Buschert 2011).

Earlier studies described drawing names from a hat or a sealed

container, where it was possible to obtain details of the randomi-

sation procedure.

Blinding

Performance bias

With psychological interventions, unlike drug trials, it is impos-

sible to totally blind participants and staff to treatment. Partici-

pants will often be aware that they are being treated preferentially

and the staff involved may have different expectations of treat-

ment groups. There may also be ’contamination’ between groups

in terms of group sessions not being held in separate rooms and

staff bringing ideas from one group to another, so that control

participants receive elements of cognitive stimulation. The latter

effect would be reduced with clear therapeutic protocols, the ex-

istence of which was not clear in most study reports.



In relation to contamination, Wallis 1983 and Baines 1987 both

stated that the staff were unaware of the allocation of participants

to groups, as they were removed from the ward setting for treat-

ment, and several other studies described the groups being run in

a separate or specific room (for example Ferrario 1991; Spector

2001; Spector 2003; Woods 1979).

Detection bias

Most studies took steps to ensure that at least part of the assessment

of outcomes was carried out by assessors blind to treatment allo-

cation. Only three studies (Baldelli 1993a; Baldelli 2002; Ferrario

1991) did not report blinding of assessors. Of course, even inde-

pendent assessors may be given clues from participants during the

assessments, but this was not reported as an issue in the studies

reviewed here. Using independent assessors works well for evalu-

ating changes in cognition or self-reported mood, well-being and

quality of life. Ratings of day-to-day behaviour and function are

typically carried out by care staff, who may be more difficult to

keep blind to group allocation, unless the group sessions were car-

ried out in a separate location to which all participants were taken.

Incomplete outcome data

Only two studies described following an intention-to-treat analy-

sis plan (Chapman 2004; Spector 2003). In contrast, Breuil 1994

stated that “All those who for any reason did not attend all eval-

uation and training sessions were eliminated”, with five partici-

pants excluded on this basis (three from the cognitive stimulation

group).

All studies reported data on attrition. Given the nature of the con-

dition and the age of the participants, attrition in several stud-

ies was remarkably small, with zero attrition recorded in six stud-

ies (Baines 1987; Baldelli 1993a; Baldelli 2002; Bottino 2005;

Buschert 2011; Coen 2011), out of 180 participants. The largest

attrition rate was reported by Wallis 1983 where there was 39%

attrition in the group of participants with dementia. In this study

patients who attended less than 20% of the group sessions were

eliminated from the study. Requena 2006 reported 32% attrition

but this was over a two year period. The two largest studies had

rates of 19% (Onder 2005) and 17% (Spector 2003) over periods

of six months and two months respectively.

Other potential sources of bias

The absence of detailed treatment protocols raised queries regard-

ing the extent to which the cognitive stimulation was delivered

as intended (having noted that there may have been differences

in emphases between studies in any case). Several studies noted

that staff received training or supervision, or both, in running the

groups and, from an early study, Woods 1979 stated in a personal

communication that “A sample of sessions were tape-recorded and

rated to ensure compliance with the therapeutic protocol”. More

recently, Chapman 2004 described weekly meetings to ensure their

treatment programme was implemented as designed. Subgroups

were led by a licensed speech-language pathologist and three mas-

ter’s level speech-language pathology students; all underwent two

hour training before the groups started and weekly meetings were

held to ensure that the programme was implemented as designed.

Onder 2005 described how family caregivers were trained by a

multi-disciplinary team and given a manual and specific schedules

for each session. No records were made, however, of how often

caregivers did deliver the sessions, or how closely the manual was

followed.

Effects of interventions

For meta-analyses we used RevMan 5.1.

Cognition

(See Figure 1)



Figure 1. Forest plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation, outcome:

Cognition.



For the overall evaluation of the effects of cognitive stimulation

on cognitive function, all 14 RCTs which included useable data

immediately post-treatment were included, including a total of

658 people with dementia of whom 377 received cognitive stim-

ulation and 281 received no treatment or a placebo treatment. As

most studies included more than one measure of cognitive func-

tion, this analysis was conducted on the most extensive assessment

included. For seven studies this was the ADAS-Cog, and for two

each it was the MMSE and CAPE Information/Orientation scales.

The overall effect size, the standardised mean difference (SMD)

was 0.41 (95% CI 0.25 to 0.57). This was a statistically significant

finding (Z = 5.04, P < 0.00001). For the seven studies, including

434 participants, using the ADAS-Cog as an outcome measure

(Figure 2), the mean difference between the cognitive stimulation

and control groups was 2.27 points (95% CI 0.99 to 3.55), a

statistically significant difference (Z = 3.48, P < 0.0005). In to-

tal, 10 studies involving 600 participants used the MMSE (Figure

3). The overall mean difference was 1.74 points (95% CI 1.13

to 2.36). Again, this was a statistically significant difference (Z =

5.57, P < 0.00001). These analyses were strongly influenced by

two of the more recent studies, Spector 2003 and Onder 2005,

which were relatively large and had smaller confidence intervals

around their reported mean differences. Five of the older studies

involving 81 participants used other measures of information or

orientation (Figure 4); here the SMD was no smaller (SMD 0.45,

95% CI -0.01 to 0.90) and was just statistically significant despite

the much smaller numbers involved (Z = 1.93, P = 0.05).

Figure 2. Forest plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation, outcome: ADAS-

Cog.



Figure 3. Forest plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation, outcome: MMSE.

Figure 4. Forest plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation, outcome: Other

cognitive measure: Information/Orientation.



The largest effect sizes were seen at the 12 month time point in the

Requena 2006 study (SMD 0.70 on ADAS-Cog) and the Baldelli

1993a study (SMD 0.99 on MMSE), both of which offered above

average durations of exposure to cognitive stimulation. However,

Breuil 1994, which offered only 10 hours exposure, also had an

above average effect size (0.63 on global cognitive score) and other

studies with longer exposure (for example Ferrario 1991) had be-

low average effect sizes. The 24 month data from Requena 2006

indicated that effect sizes appeared to be maintained through con-

tinued exposure (ADAS-Cog SMD 0.66: MD 11.94 points, 95%

CI -0.97 to 24.85; MMSE SMD 0.56: MD 5.99 points, 95% CI

-1.58 to 13.56). However, these effects require replication as the

confidence intervals were broad and crossed zero.

Communication and social interaction

(See Figure 5)

Figure 5. Forest plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation: post-treatment,

outcome: Comunication and social interaction.

Four studies, involving 223 participants, included staff ratings of

the person’s communication and social interaction (outside of the

cognitive stimulation group), three using the Holden Commu-

nication Scale. The overall effect size (SMD) was 0.44 (95% CI

0.17 to 0.71) with participants in the cognitive stimulation groups

showing a significant improvement in this area (Z = 3.15, P =

0.002). Spector 2003 was the most influential study in this anal-

ysis, although the effect was not reported as significant in the pri-

mary study report.

Well-being and quality of life

(See Figure 6)



Figure 6. Forest plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation, outcome: QoL-

AD.

Four studies, involving 219 participants, included relevant self-

report measures. Baines 1987 used the Life Satisfaction Index and

Spector 2003, Buschert 2011 and Coen 2011 used the QoL-AD.

The meta-analysis indicated that cognitive stimulation was asso-

ciated with a significant benefit to well-being and quality of life

compared with no treatment (SMD 0.38, 95% CI 0.11 to 0.65)

(Z = 2.76, P = 0.006). The Spector 2003 findings were again a

major influence.

Mood

(See Figure 7; Figure 8)




Geriatric Depression Scale (GDS-30)


outcome: Mood: Staff-reported.



Five studies, involving 201 participants, used a self-report measure

of mood (the Geriatric Depression Scale or the MADRS). Cog-

nitive stimulation was not associated with a clear improvement in

mood across these studies. The SMD was 0.22 (95% CI -0.09 to

0.53) (Z = 1.42, P = 0.16).

Staff ratings of mood and anxiety similarly did not show any bene-

fit from cognitive stimulation. Four studies, involving 239 partici-

pants, contributed to this analysis, two using the Cornell Scale for

Depression in Dementia, a third using a subscale of the MOSES

scale and the fourth the Rating of Anxiety in dementia. The SMD

was close to zero in this domain (SMD 0.05, 95% CI -0.21 to

0.31).

Behaviour

(See Figure 9; Figure 10; Figure 11)

Figure 9. Forest plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation, outcome: ADL.


Behavior, Other.




outcome: Behaviour, problem.

Three separate meta-analyses were conducted in this domain. One

focused on activities of daily living (ADL) and basic self-care skills;

a second focused on behaviours seen as a problem, such as irritabil-

ity, being demanding and difficult. The third included ’general’

behaviour rating scales, which may include some of the previous

two aspects, together with some higher level daily living skills.

Four studies, involving 160 participants, used ADL scales. There

was no benefit identified with cognitive stimulation (SMD 0.21,

95% CI -0.05 to 0.47) (Z = 1.56, P = 0.12). Three studies, in-

cluding 166 participants, used scales evaluating behaviour prob-

lems. Again there was no difference related to cognitive stimula-

tion (SMD -0.14, 95% CI -0.44 to 0.17) (Z = 0.86, P = 0.39).

General behaviour rating scales showed a similar picture, with no

difference emerging. Eight studies, including 416 participants, re-

ported data on relevant scales (SMD 0.13, 95% CI -0.07 to 0.32)

(Z = 1.30, P = 0.20).

Caregiver outcomes

(See Figure 12)




outcome: Caregiver outcome.

Three studies reported on outcomes for family caregivers. The

largest of these (Onder 2005) taught family caregivers to deliver the

cognitive stimulation, so the effects on caregivers were especially

pertinent for that study. The effect sizes for anxiety, depression and

caregiver burden were all close to zero (SMDs 0.11, 0.04, -0.03

respectively), with confidence intervals crossing zero indicating

no differences between the caregivers in the cognitive stimulation

condition and those in the control conditions.

Only one study (Baines 1987) reported outcomes for care staff, so

no meta-analysis was possible. The results of this study indicated

a significant increase in staff knowledge about residents partici-

pating in the cognitive stimulation intervention compared with

knowledge of residents in the control condition.

Follow-up

The analyses for assessments carried out after the intervention had

been completed were reported in two groups: Baines 1987 and

Wallis 1983 had a one month follow-up, and Baldelli 1993a a

three month follow-up on certain measures. These three studies

represent a short term follow-up; whereas Chapman 2004 reported

useable data only from a 10 month follow-up, a much longer

period in the context of the progression of dementia.

For cognitive measures (Figure 13), the three older studies with

short term follow-up reported data for 52 participants. The signif-

icant advantage for cognitive stimulation on cognitive measures

seen immediately post-treatment remained at this point (SMD

0.57, 95% CI 0.01 to 1.14) (Z = 2.00, P = 0.05). For the 54

participants included by Chapman 2004, there was no significant

effect on either the MMSE (SMD 0.18) or the ADAS-Cog (SMD

0.12) at the 10 month follow-up.



Figure 13. Forest plot of comparison: 2 Cognitive stimulation vs No Cognitive Stimulation: follow-up,

outcome: Cognition.

For self-report well-being and quality of life measures (Figure

14), the only short term follow-up data came from Baines 1987,

with only 10 participants, and showed no differences. The longer

term follow-up from Chapman 2004 showed a SMD of 0.34 for

the QoL-AD measure but this difference was not significant. No

measures of mood were included in the studies reporting follow-

up.


outcome: Well-being & Quality of Life.



For general behaviour rating scales (Figure 15), two studies re-

ported short term follow-up, with 29 participants. The SMD of

0.44 was not significant. Similarly at 10 months the scale used by

Chapman 2004 showed a non-significant SMD of 0.43. A similar

picture appeared in relation to problem behaviour (Figure 16),

where there was only one small study in the short term follow-

up group (Baines 1987) and the longer term follow-up reported

by Chapman 2004 did not show a significant difference on either

the Neuropsychiatric Inventory (NPI) severity score (SMD 0.29)

or the caregiver distress score related to the problem behaviour

(SMD 0.41).


outcome: Behaviour, general.


outcome: Behaviour, problem.



Finally, there were no differences in measures of communication

and interaction (Figure 17) at either short term (Baines 1987) or

longer term follow-up (Chapman 2004).


outcome: Communication and social interaction.

D I S C U S S I O N

In total, 15 RCTs with a total of 718 participants (407 receiving

cognitive stimulation, 311 in control groups) met the inclusion

criteria for the meta-analyses. The most striking finding reflects

the effects of cognitive stimulation on performance in tests of cog-

nitive function. The results of the meta-analyses reported here in-

dicate that cognitive stimulation programmes for dementia have

a significant positive effect on cognition, which is evident in the

post-2000 studies included in this review as well as in the older

studies which were included in our previous review of Reality Ori-

entation. This is perhaps the most consistent finding in the liter-

ature on psychological interventions with people with dementia.

The studies included here came from a variety of countries and

contexts, from France, the UK, Italy, Spain and Brazil; from hospi-

tal, care home, nursing home, day centre and outpatient settings;

and administered in groups by staff or volunteers, or individually

by family caregivers.

The extent to which these changes in cognitive function are clini-

cally important has not been generally addressed. An average ben-

efit of 1.74 points on the MMSE or 2.27 points on the ADAS-

Cog can be taken to indicate a slowing down of the rate of de-

cline, which has been estimated, in mild to moderate dementia,

to be between 2 and 4 points on the MMSE per annum (Mohs

2000). In relation to the number needed to treat (NNT) for one

more participant in the treatment group than in the control group

to benefit by a certain amount, Spector 2003 and Onder 2005

provide some evidence. For an improvement of 4 or more points

on the ADAS-Cog, Spector 2003 calculated an NNT of 6, and

Onder 2005 14, figures broadly comparable to those seen in trials

of the ACHEIs.

However, as has been pointed out repeatedly over the years (Woods

2006), changes in cognition are not sufficient to justify an exten-

sive programme of intervention, unless they are accompanied by

other changes, in behaviour and well-being. Here there are two

positive findings. Firstly, results from four RCTs (with 223 par-

ticipants) indicated that positive changes in communication and

social interaction were evident in staff ratings outside the context

of the cognitive stimulation group sessions. Secondly, results from

four RCTs (219 participants) identified a benefit on quality of life

and well-being associated with cognitive stimulation.

In contrast, there was no indication that cognitive stimulation was

associated with changes in mood, whether self-rated or rated by

staff, or in behaviour including activities of daily living and self-



care and problem behaviour. It is notable that in general there is

much less evidence available regarding these domains compared

with that available for changes in cognition. No benefits to family

caregivers were identified in terms of mood or caregiver burden.

However, it is important to note that in the study where the re-

sponsibility for delivering the cognitive stimulation fell on famiy

caregivers (Onder 2005), this additional task did not appear to

add to their stress and strain. One study showed an improvement

in care home staff knowledge of residents following participation

in cognitive stimulation.

There is little evidence available on the cost-effectiveness of cog-

nitive stimulation (CST). Knapp 2006 reported cost-effective-

ness acceptability curves for cognition and quality of life from the

Spector 2003 trial and conclude that, for both outcomes, ’under

reasonable assumptions, there is a high probability that CST is

more cost-effective than treatment as usual’.

These findings all relate to the assessment point immediately af-

ter the treatment period has been completed. Only four relatively

small studies reported data on whether any changes were main-

tained after a period of follow-up without further intervention.

Here, again, cognition stands out with three RCTs showing a pos-

itive effect evident at a follow-up of one to three months after

the intervention; this was not evident in the one RCT reporting a

10 month follow-up. Other follow-up data were limited in their

extent and scope but there were no indications of benefits in the

areas of behaviour and well-being that were evaluated.

A key area of difference between studies relates to the duration

and frequency of the cognitive stimulation offered, leading to a

wide variation in the ’dosage’ of cognitive stimulation received, as

indicated by the total number of hours of stimulation offered. As

pointed out previously, there does not appear to be a clear relation-

ship between dosage and the effect size on cognitive function in the

various studies; the Spearman’s correlation was 0.25 (N = 14, P =

0.392). It is difficult to ascertain whether the frequency of sessions

per week makes a difference as the study with the largest effect

sizes (Requena 2006) has five 45-minute sessions per week and

has the longest duration. As the duration increases, the anticipated

decline associated with dementia should tend to reduce the effects

of cognitive stimulation, and so a simple linear relationship is un-

likely to hold. One study (Requena 2006) continued cognitive

stimulation for two years. The decision was made to include one

year data from this study in the primary meta-analyses reported

here, to reduce the impact of attrition. However, the effects on

cognition and self-reported mood appeared to be sustained over a

further one year period, although the effects were not statistically

significant in our analyses. There is a need for further research

on maintenance cognitive stimulation, looking at whether lower-

intensity input maintains gains from an initial period of cognitive

stimulation (Aguirre 2010).

In five of the included studies all of the participants were pre-

scribed ACHEI medication. For the four of these RCTs providing

post-treatment data, the additional effect of cognitive stimulation

over and above the medication was 3.18 points on the ADAS-

Cog, compared with the overall finding (from seven RCTs) of 2.27

points. This supports the proposition that cognitive stimulation

is effective irrespective of whether or not ACHEIs are prescribed,

and any effects are in addition to those associated with the med-

ication. One study (Requena 2006) reported comparative results

from a control group who received neither cognitive stimulation

nor an ACHEI, but this was not a randomly allocated condition

so that the additive effects of these two treatment approaches were

not established compared with no treatment. Such a study would

perhaps not now be seen as ethical in a context where ACHEIs are

seen as standard treatment for Alzheimer-type dementia.

In general, it appears that outcome measures rated by staff are less

likely to indicate positive change than those that are completed by

the person with dementia directly with an assessor blinded to the

treatment received. In a care home or hospital context, it is well

known that achieving consistent staff ratings in research studies

such as these is a major challenge. It can often be impossible to

have the same staff member rate the person at each time point due

to staff turn-over and sickness. There can be a ’drift’ in ratings over

time, even with the same rater. The observation period and op-

portunities for observation may vary over time. Maintaining staff

blind to treatment allocation is more challenging than for an as-

sessor who only visits the facility to carry out the assessments. The

one area of staff-rated behaviour showing change in this review re-

lates to communication and social interaction, an area that has not

been highlighted in previous reviews of this type of intervention.

Given the social emphasis of cognitive stimulation groups, this is

an area of behaviour that is most closely linked to the content of

the intervention. Indeed, Spector 2010 have demonstrated that

in their study language function was an area of specific cognitive

improvement.

Inevitably where the control condition is ’no treatment’, the ques-

tion is raised as to whether any benefits associated with the treat-

ment arise from non-specific effects such as meeting as a group,

socialising, increased attention and so on. A few early studies did

include an ’attention’ control group (Woods 1979) or diversional

occupational therapy (Wallis 1983) and one study offered physi-

cal rehabilitation sessions to both groups (Baldelli 2002). In the

Requena 2006 study where stimulation materials were presented

on a TV screen to the group, control participants watched TV

elsewhere. Although we cannot provide a definitive conclusion on

this matter, our results did not indicate any effects of these dif-

ferent control conditions on outcome. In a mediation analysis,

Woods 2006 demonstrated that in the Spector 2003 RCT the im-

provements in quality of life were mediated by improvements in

cognition, suggesting that it is the cognitive focus of the cognitive

stimulation therapy programmes (rather than merely the social

contact and attention) which lead to improved well-being. Fur-



ther work is required to explore the relationship between changes

in cognition and the changes in well-being and quality of life and

communication that are emerging from the current review.

The quality of the included studies is variable, and generally low,

with lack of clarity regarding randomisation procedures being evi-

dent in around half the studies (including some of the more recent

studies). CONSORT type diagrams depicting the flow of partic-

ipants through the trial are provided by four of the recent studies

(Bottino 2005; Buschert 2011; Onder 2005; Spector 2003) and,

along with remote, independent randomisation, will be a mini-

mum expectation in future trials. The number of participants in-

cluded has increased markedly from an average of 23 per study

prior to 2000 to 64 in the nine more recent studies. Larger sample

sizes will necessitate multi-centre trials, for example Spector 2003

recruited from 23 centres. This will have implications for analy-

ses, with cluster effects within a centre, even though participants

are individually randomised. Spector 2003 accordingly included

centre as a covariate in their analyses. Studies do not yet appear

to have taken account of clustering effects arising from a group

intervention. This occurs where changes in group members are

not entirely independent. Group leaders often report that some

groups seem to work much better than others for example. Inten-

tion-to-treat analyses were only described by two (recent) studies,

although in most cases details of attrition were reported. The need

for assessors to be blind to treatment allocation is widely recog-

nised and attempted in most studies. More attention may need to

be given in future studies to demonstrating the extent to which

the cognitive stimulation is delivered as planned. Well-developed

treatment manuals will help with assuring the replicability of the

intervention. In general, there is a clear improvement in overall

quality of the included studies over time, for example in the more

consistent information given regarding the diagnosis of partici-

pants and the criteria used, as well as the use of consistent outcome

measures and larger sample size.

The studies included in the review utilised therapists with a variety

of backgrounds, experience and training. They included volun-

teers, family caregivers, speech and language therapists, occupa-

tional therapists, nurses, care workers and research staff. There are

no indications from this review of the amount or type of training

required to deliver cognitive stimulation, although there is broad

agreement that whilst training is needed the therapist does not

need a professional qualification. Given the concerns regarding RO

being delivered in a mechanical, dehumanising fashion (Dietch

1989), training and supervision in person-centred care would be

seen as a prerequisite for delivery of cognitive stimulation. In this

review, there were no reported side effects or adverse effects of any

of the cognitive stimulation interventions. Attrition was due to

expected reasons in studies of this nature: illness, death, transfer to

another facility and occasional refusal to complete follow-up as-

sessments. With only one study utilising an individual approach,

in contrast to offering group cognitive stimulation, it is not possi-

ble to draw on any evidence on the strengths and benefits of these

different treatment modalities.

The range of severity of dementia experienced by patients in-

cluded in the studies reviewed here ranged from mild to moder-

ate. There was no indication that the two studies with the lowest

mean MMSE scores of participants (Spector 2001; Spector 2003)

had any different effects than those with more mildly impaired

participants. Most studies included a mixture of participants with

mild and moderate dementia. Onder 2005 indicated that there

was no differential benefit to either group, with no significant in-

teraction between severity of dementia and treatment on change

in either MMSE or ADAS-Cog scores. More work may be needed

to define if there are people with dementia, or subgroups, who

are more or less likely to benefit from a cognitive stimulation in-

tervention. No analyses have been attempted here seeking to es-

tablish whether different subtypes of the dementias show specific

responses to cognitive stimulation. One study (Baldelli 2002) in-

cluded only participants who had had a cerebrovascular accident

(CVA), although less than half the participants had a diagnosis of

vascular dementia. Most recent studies have included those who

are receiving AChEI medication, with a probable Alzheimer’s diag-

nosis, whereas Spector 2003 included all types of dementia. Given

that the average age of participants across the review was almost

80 years (over 85 in the Spector 2003 study), it is highly likely that

neurodegenerative and vascular changes are co-occurring in the

majority of participants, and so the distinction may be of limited

pragmatic utility.

The findings of this review are broadly in line with other more

wide-ranging reviews of non-pharmacological interventions in de-

mentia. Livingston 2005 gives a relatively strong recommendation

for cognitive stimulation in relation to its effects on neuropsychi-

atric symptoms, including mood, but notes some inconsistencies

in the evidence on these outcomes. Sitzer 2006 included 17 studies

in their meta-analysis of ’cognitive training’ in Alzheimer’s disease,

four of which met our definition of ’cognitive stimulation’ and

three of which are included in this review. Sitzer 2006 concludes

that there is a medium effect size (0.47) across all types of ’train-

ing’ over the whole range of outcome measures, making ’cogni-

tive training’ a promising intervention. However, it is notewor-

thy that general stimulation techniques were prominent in four

of the five trials reporting the most beneficial results, with the

review describing these as ’restorative strategies’. Olazaran 2010

reviewed 179 RCTs across 26 categories of non-pharmacological

interventions. They concluded that there was ’Grade B’ evidence

(consistent evidence from lower quality RCTs) for cognitive stim-

ulation in relation to cognition, behaviour and psychological well-

being. They did not identify any ’Grade A’ evidence (consistent ev-

idence from high quality RCTs) for any interventions with people

with dementia, although some caregiver interventions did reach

this level. The 2011 World Alzheimer’s Report (Prince 2011) con-

cludes, from a wide-ranging systematic review, “We found strong



evidence (multiple RCTs) that acetylcholinesterase inhibitors (for

cognitive function, functional impairment), and cognitive stimu-

lation (for cognitive function) are effective interventions in mild

dementia” and makes the following recommendation in relation

to interventions for early-stage dementia: “Acetylcholinesterase in-

hibitors and cognitive stimulation may enhance cognitive func-

tion in people with mild Alzheimer’s disease, and these interven-

tions should therefore be routinely offered.”

Finally, consideration should be given to the possibility of publica-

tion bias in this domain. By reviewing only the studies on cognitive

stimulation that have been published in peer-reviewed journals, it

must be acknowledged that these could represent a biased sample

of the studies undertaken world-wide on this topic. In many fields

of endeavour, trials that are not successful (that is do not produce

the expected positive findings) are less likely to be published. This

may be especially the case with smaller trials. The welcome trend

to pre-registration of trials, and the publication of trial protocols,

makes this less likely to occur in the future in relation to larger,

well-funded trials. The meta-analyses here have been influenced

strongly by the larger trials included (such as Spector 2003 and

Onder 2005), and a funnel plot of the cognition outcome appears

reasonably symmetrical (Figure 18) suggesting that possible pub-

lication bias is not a strong factor for this outcome at least.

Figure 18. Funnel plot of comparison: 1 Cognitive Stimulation vs No Cognitive Stimulation: post-

treatment, outcome: 1.1 Cognition.

A U T H O R S ’ C O N C L U S I O N SImplications for practice

The evidence base for the effectiveness of cognitive stimulation

therapy for dementia in relation to cognitive function has been

consistently demonstrated, with small changes reported in multi-

ple trials on commonly used brief measures of cognitive function;

adverse effects have not been reported. There is now evidence from

a small number of studies that cognitive stimulation may also be

associated with improvements in quality of life and communica-

tion. These benefits are over and above any medication effects.



This review is consistent with the NICE-SCIE 2006 Guideline

recommendation that all people with mild to moderate demen-

tia should have the opportunity to participate in cognitive stim-

ulation groups, irrespective of whether or not they are receiving

acetylcholinesterase inhibiting medication (ACHEIs). This rec-

ommendation was recently reinforced by the World Alzheimer’s

Report (Prince 2011).

Although more research is needed, results from one study suggest

that continuing involvement in cognitive stimulation may be ben-

eficial.

Implications for research

There are a number of areas, relating to both theory and practice,

where further research is required. Now that its effects are becom-

ing better established, the theoretical basis of cognitive stimulation

would benefit from fuller investigation. This would involve study-

ing cognitive changes both in relationship to neural processes and

pathways; and their linkage, if any, with outcomes such as mood,

quality of life, day-to-day function and behaviour.

There is a clear need for more randomised controlled trials of cog-

nitive stimulation exploring the long term benefits of this inter-

vention. The effects of severity of dementia and different modali-

ties (for example group versus with caregiver) need to be system-

atically evaluated. These RCTs may be of particular value if used

in conjunction with more qualitative studies in order to under-

stand the relationships between the different outcome measures.

The clinical meaningfulness of any benefits needs to be examined,

particularly in relation to the impact of any cognitive changes. Are

there benefits in terms of increased participation in activities of

importance to the person, increased social inclusion or of individ-

ual goals being attained?

Only one cost-effectiveness study has been identified to date and

this gap should be addressed, particularly in relation to clinically

meaningful benefits.

Finally, the implementation of cognitive stimulation in real-life

settings needs to be addressed. The key issue here is whether the

results obtained by those who attend brief training in the methods

or make use of one of the treatment manuals that have been de-

veloped, or both, are comparable to those obtained in the context

of research studies and RCTs.

A C K N O W L E D G E M E N T S

Maintenance Cognitive Stimulation Programme (IS-

RCTN26286067) is part of the Support at Home - Interventions

to Enhance Life in Dementia (SHIELD) project (Application No

RP-PG-0606-1083) which is funded by the NIHR Programme

Grants for Applied research funding scheme. The grant holders

are Professors Orrell (UCL), Woods (Bangor), Challis (Manch-

ester), Moniz-Cook (Hull), Russell (Swansea), Knapp (LSE) and

Dr Charlesworth (UCL). The views and opinions expressed in this

review are those of the authors and do not necessarily reflect those

of the Department of Health/NIHR. The authors wish to thank

Joanne Knowles for acting as consumer reviewer for this review.

R E F E R E N C E S

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Quayhagen MP, Quayhagen M, Corbeil RR, Roth PA,

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153–9.

Quayhagen 2000 {published data only}

Quayhagen MP, Quayhagen M, Corbeil RR, Hendrix

RC, Jackson JE, Snyder L, et al.Coping with dementia:

Evaluation of four non pharmacologic interventions.

International Psychogeriatrics 2000;12(2):249–65.

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Reeve 1985 {published data only}

Reeve W, Ivison D. Use of environmental manipulation and

classroom and modified informal reality orientation with

institutionalized, confused elderly patients. Age and Ageing1985;14(2):119–21.

Riegler 1980 {published data only}

Riegler J. Comparison of a reality orientation program for

geriatric patients with and without music. Journal of Music

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Salmon N. Cognitive stimulation therapy versus acetyl

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Development and evaluation of an interactive computer-

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Schreiber M, Schweizer A, Lutz K, Kalveram KT, Jancke

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Geriatrics Society 2009;57(4):594–603.


Spector A, Woods B, Orrell M. Cognitive stimulation

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adults following brain injury. The Journal of Head Trauma

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Improved quality of life and cognitive stimulation therapy

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Zanetti O, Frisoni GB, De Leo D, Dello Bueno M,

Bianchetti A, Trabucchi M. Reality orientation therapy

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association of donepezil and Reality Orientation Therapy.

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Zepelin H, Wolfe CS, Kleinplatz F. Evaluation of a year

long reality orientation program. Journal of Gerontology1981;36(1):70–7.

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o grupal en la estimulacion cognitiva de pacientes con

enfermedad de Alzheimer]. Revista de Psicopatología y

Psicología Clínica 2010;15:115–23.

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for dementia. Trials 2010;11:46.

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activity for the treatment of older adults with mild

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References to other published versions of this review

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C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Baines 1987

Methods RCT

Cross-over design: (only results from first phase are included in this review)Treatment 1: 4 weeks; 4 week ’wash-out’ period’; Treatment 2: 4 weeks

Participants N=15 (14F, 1M)

’Moderate to severe Impairment of cognitive functioning’

Mean age=81.5 (range 72-90)

Living in care home

Interventions RO

Reminiscence

Treatment as usual

Outcomes Cognitive: Information/Orientation & Mental Ability (CAPE)

Behaviour: Behavioural Rating Scale (CAPE)

Well being: Life Satisfaction Index;

Problem Behaviour Rating Scale

Communication : Holden Communication Scale

4 week follow-up data available

Staff completed ’Personal Information Questionnaire’, evaluating staff knowledge of

residents

Notes Treatment duration 30 minute sessions, 5 days a week for 4 weeks

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection

bias)

Unclear risk No details of the randomisation method

used reported in the paper

Allocation concealment (selection bias) Unclear risk No details of the randomisation method

used reported in the paper

Blinding (performance bias and detection

bias)

All outcomes

Low risk RO groups held in separate areas;

Blinding of outcome assessment (detection

bias)

All outcomes

Low risk Cognitive assessments made by an inde-

pendent psychologist; other ratings made

by staff not involved in the therapy groups

Incomplete outcome data (attrition bias)

All outcomes

Low risk No attrition at follow-up assessment



Baldelli 1993a

Methods RCT

Participants N=23 (23F/0M)

Alzheimer’s (SDAT)

Mean MMSE 20.6 (sd 4.9)

Mean age 84.5 (range 75-94)

All resident in institution

Interventions RO

Treatment at usual

Outcomes Cognition: MMSE; Berg Orientation Scale

Mood: GDS-30

ADL: Stewart ADL scale

3 month follow-up data on cognitive measures

Notes 60 minutes, 3 times a week for 3 months

Risk of bias



bias)

Unclear risk Stated by e-mail that their trials were randomised (with no detail

of the methods used)

Allocation concealment (selection bias) Unclear risk Stated by e-mail that their trials were randomised (with no detail



bias)

All outcomes

Unclear risk No evidence of blinding in the paper


bias)

All outcomes

Unclear risk No details of who assessors were


All outcomes

Low risk Zero attrition at 3 month post-treatment assessment; no attrition

reported at follow-up 3 months later

Baldelli 2002

Methods RCT

Participants N= 87 (61F/26M)

’Degenerative senile dementia of the Alzheimer’s type (SDAT)’ (N=46) and “vascular

multi-infarct dementia” (N=41)

Mean MMSE 20.7 (sd 3.0)

Mean age 80.0 (range 65-97)

Resident in sub-acute care nursing home



Baldelli 2002 (Continued)

All had at least elementary schooling

’All had comorbid conditions consisting of vascular accidents with acute motor deficits

of recent onset’

Interventions RO + physical therapy programme.

Physical therapy programme only

Outcomes Cognition: MMSE

Mood: Geriatric Depression Scale (GDS 30)

ADL: Barthel

Notes 60 minutes, 5 days per week for one month

Risk of bias



bias)

Unclear risk Stated by e-mail that their trials were randomised (with no detail


Allocation concealment (selection bias) Unclear risk Stated by e-mail that their trials were randomised (with no detail



bias)

All outcomes

Unclear risk No evidence of blinding in the paper


bias)

All outcomes

Unclear risk No details of assessors given


All outcomes

Low risk No attrition reported

Bottino 2005

Methods RCT

Participants N=13 (9F / 4M)

’Mildly impaired probable Alzheimer’s diagnosis’

All participants taking rivastigmine 6-12mg/day for 2 months

Mean MMSE 22.31 (sd 3.61; range 16-28)

Age 73.7 (range 62-83)

Out-patients

Interventions ’cognitive rehabilitation’ plus rivastigmine; carers attended a support group at same time

Treatment as usual: rivastigmine plus 30 minute monthly consultation with doctor in

relation to medication



Bottino 2005 (Continued)

Outcomes Participants:

Cognition: MMSE; ADAS-Cog,

ADL (rated by carer)

Carers’ mood: Hamilton Anxiety and Montgomery-Asberg Depression Rating Scales

Notes 90 minutes, once a week, for 5 months

Risk of bias



bias)

Low risk Randomised blocks design, randomly allocated to either group

by telephone by an assessor blind to the patient group

Allocation concealment (selection bias) Low risk Randomised blocks design, randomly allocated to either group

by telephone by an assessor blind to the patient group


bias)

All outcomes

Low risk Assessment made by assessors blinded to group allocation


All outcomes

Low risk No attrition reported

Breuil 1994

Methods RCT

Participants N= 61 (37F / 24M)

Diagnosis of dementia (DSM-III) (90% have Alzheimer’s Disease)

Age 77.1 (range 61-93)

Mean MMSE 21.5 (range 9-29)

Out-patients

Interventions Cognitive stimulation

Treatment as usual

Outcomes Cognition: MMSE, CERAD

ADl: ECA scale rated by family members

Notes 60 minutes, 2 times a week, for 5 weeks

Risk of bias



bias)

Unclear risk No details of randomisation reported



Breuil 1994 (Continued)

Allocation concealment (selection bias) Unclear risk No details of randomisation reported


bias)

All outcomes

Low risk Cognitive assessments made by an assessor blind to group allo-

cation; ADL assessment open


All outcomes

Low risk Five patients excluded as did not attend all training and evalua-

tion sessions (3 from treatment group, 2 from controls)

Buschert 2011

Methods RCT

Participants N=39

24 amnestic MCI; 15 mild Alzheimer’s disease (only data on Alzheimer’s patients reported

in this review) 8F/7M

Mean MMSE 24.9 (sd 1.6; range 22-27)

All on stable doses of AChEIs or memantine

Age 75.9 (sd 8.1)

Out-patients

Interventions Multi-component cognitive group intervention - for AD group emphasis on cognitive

stimulation (for MCI group more emphasis on cognitive training); Control group had

pencil and paper exercises for self-study and monthly meetings

Outcomes Cognition: MMSE; ADAS-Cog, Trail Making Test, RBANS story memory & recall

Quality of life: QoL-AD

Mood: Montgomery Asberg Depression Rating Scale

Notes 2 hours, once a week for 6 months (20 sessions)

Risk of bias



bias)

Low risk Blocked randomisation procedure; participants pooled in pairs

with respect to age, gender, education and ApoE genotype, then

randomly assigned pairs to intervention or control using a com-

puterised random number generator

Allocation concealment (selection bias) Low risk Blocked randomisation procedure


bias)

All outcomes

Unclear risk Assessors blind to group allocation



Buschert 2011 (Continued)


All outcomes

Low risk No attrition

Chapman 2004

Methods RCT

Participants N= 54 (29F / 25M)

probable AD, on stable dose of donepezil for at least 3 months

Mean MMSE 20.87 (sd 3.55, range 12-28)

Age 76.4 (range 54-91)

Living at home initially

Interventions cognitive stimulation + donepezil

Donepezil only

Outcomes Cognition: MMSE; ADAS-Cog;

ADL: Texas Functional Living Scale

Behavioural problems: NPI - Irritability and Apathy

Quality of Life: QoL-AD

Global functioning: CBIC

Verbalisation: Composite discourse score

Carer distress - derived from the NPI

10 month follow up data available

Notes 90 minutes, once a week, for 8 weeks

Risk of bias



bias)

Low risk Independent randomisation, using an SAS procedure

Allocation concealment (selection bias) Low risk Remote telephone randomisation


bias)

All outcomes

Unclear risk Carer ratings not blind to allocation


bias)

All outcomes

Low risk All raters underwent extensive training; assessors blinded to

group allocation


All outcomes

Low risk Intention to treat analysis used. 24% attrition rate at end of

study



Chapman 2004 (Continued)

Other bias Low risk Programme led by trained speech therapist, weekly meetings

held in order to ensure the programme is implemented as de-

signed

Coen 2011

Methods RCT

Participants N = 27 (14F/13M)

Dementia - MMSE 10-23

MMSE: 16.9 (sd 5.0)

Age: 79.8 (sd 5.6)

Groups ran in 2 long term care facilities and a private nursing home


No treatment

Outcomes Cognition: MMSE; ADAS-Cog


Communication: Holden Communication Scale

Mood: Geriatric Depression Scale (14 item); RAID (Rating of Anxiety in Dementia)

Behaviour: Behaviour Rating Scale (CAPE)

Clinical Dementia Rating (sum of boxes)

Notes 45 minutes, 2 times a week for 7 weeks

Risk of bias



bias)

Unclear risk Stated that participants were randomly assigned. Author con-

firms computerised randomisation and random number tables

were used

Allocation concealment (selection bias) Unclear risk Stated that participants were randomly assigned. Author con-

firms computerised randomisation and random number tables

were used


bias)

All outcomes

Unclear risk Staff running groups also involved in other activities, involving

control participants


bias)

All outcomes

Unclear risk Tests administered by staff blind to group membership. Not

clear if staff ratings were made by staff who wre blinded


All outcomes

Unclear risk No attrition



Coen 2011 (Continued)

Other bias Unclear risk Sessions run by occupational therapists and activity coordinator

Ferrario 1991

Methods RCT

Participants N=19 (8F / 11M)

elderly patients with cognitive disturbances

MMSE range 18-25

Age 82.5 (sd 5.2)

Resident in institution

Interventions RO

No treatment

Outcomes Cognition: CAPE I/O

Self-care: MOSES

Behaviour problems: MOSES - irritable, withdrawn

Mood: MOSES


Risk of bias



bias)

Unclear risk Stated by e-mail that the trial was randomised (with no detail of

the methods used)

Allocation concealment (selection bias) Unclear risk Stated by e-mail that the trial was randomised (with no detail of

the methods used)


bias)

All outcomes

Unclear risk No information given in relation to where groups were held,

but RO materials were in evidence on the ward - may have been

accessed by control participants?


bias)

All outcomes

Unclear risk MOSES completed by nursing staff - not clear if raters were

blind


All outcomes

Low risk 2 dropouts (/21). 1 in each group (pneumonia and stroke). (In-

formation provided by the author)

Other bias Low risk RO administered by volunteers trained by physicians and psy-

chologist



Onder 2005

Methods RCT

Participants N = 156 (113F/ 43M)

Probable Alzheimer’s Disease, on Donepezil for at least 3 months

MMSE 20.1 (sd 3.1)

Age 75.8 (sd 7.1)

Living at home

Interventions RO + Donepezil

Donepezil only

Outcomes Cognition:MMSE; ADAS-Cog

ADL: Barthel; IADL

Behaviour problems: NPI

Family caregiver outcomes: Hamilton anxiety and depression scales; Caregiver Burden

Inventory; SF-36

Notes 30 minutes, 3 times a week, for 25 weeks; plus informal contacts 2 or 3 times a day

Risk of bias



bias)

Low risk Computerised block randomisation process

Allocation concealment (selection bias) Low risk Computerised block randomisation process


bias)

All outcomes

Low risk Assessment made by blind assessors


All outcomes

Low risk Attrition data reported: 9 from RO group, 10 from control group

i.e. 19%

Other bias Low risk Family caregivers trained by a multi-disciplinary team

Requena 2006

Methods RCT

Participants N = 86 (61F / 25M)

Alzheimer-type dementia (severe dementia excluded)

MMSE 21.3

Age 77 (sd 7.5)

Attending daycare centre



Requena 2006 (Continued)

Interventions 1) Cognitive stimulation + Donepezil

2) Donepezil only

3) Cognitive stimulation only

4) No treatment

Outcomes Cognition: MMSE, ADAS-Cog

Mood: GDS-30

12 month and 24 month data reported

Notes 45 minutes, 5 times a week for 24 months

’No treatment’ group were not part of the randomisation process. Comparison of interest

to this review is cognitive stimulation + donepezil v donepezil alone

Risk of bias



bias)

Unclear risk Randomisation by registration order: ’subjects were randomly

distributed in groups at the time they arrived at the Centre’

Allocation concealment (selection bias) Unclear risk Randomisation by registration order


bias)

All outcomes

Low risk Spanish paper stated that groups were led by an independent

member of the research team


bias)

All outcomes

Low risk Spanish paper states ’Evaluator was blind to treatment allocation’


All outcomes

Low risk Attrition reported: 6/20 in CS + donepezil group; 10/30 in

donepezil alone group i.e. 32% over 2 year period

Spector 2001

Methods RCT

Participants N = 35

Diagnosis of dementia according to DSM-IV criteria

MMSE 13.1 (sd 4.4)

Age 85.7 (sd 6.7)

Living at home: 12; living in residential home: 23


Treatment as usual



Spector 2001 (Continued)



Mood: Cornell Scale for Depression in Dementia; RAID

Behaviour: Behaviour Rating Scale (CAPE).

Family caregivers: Relatives Stress Scale; GHQ


Risk of bias



bias)

Low risk Randomly allocated to either group by drawing names from a

sealed container

Allocation concealment (selection bias) Low risk Randomly allocated to either group by drawing names from a

sealed container


bias)

All outcomes

Unclear risk Not clear whether staff and carer ratings were made blind to

treatment allocation


bias)

All outcomes

Low risk Cognitive assessments made by a blind assessor


All outcomes

Low risk Attrition reported: 4 in CS group, 4 in control group i.e. 23%

Other bias Low risk Groups led by a member of the research team in a separate room

for the programme in each of the centres

Spector 2003

Methods RCT

Participants N = 201 (158F / 43M)

Dementia (DSM-IV criteria) - MMSE 10-24

MMSE: 14.4 (sd 3.8)

Age: 85.3 (sd 7.0)

Groups ran in 18 residential homes; 5 day centres


No treatment






Spector 2003 (Continued)

Mood: Cornell Scale for Depression in Dementia

Behaviour: Behaviour Rating Scale (CAPE)


Risk of bias



bias)

Low risk Randomly allocated to either group by drawing names from a

sealed container

Allocation concealment (selection bias) Low risk Randomly allocated to either group by drawing names from a

sealed container - would have been preferable for randomisation

to have been carried out independently


bias)

All outcomes

Low risk Members of staff involved in groups did not carry out ratings,

but ratings by other staff may not have been blind


bias)

All outcomes

Low risk Cognitive assessments and quality of life interview conducted

by a blind assessor


All outcomes

Low risk 34/201 did not complete study (18 CS / 16 controls); 17%

attrition

Other bias Low risk Groups led by a member of the research team in a specific room

for the programme in each of the centres, with a member of staff

Wallis 1983

Methods RCT

Participants N = 60

31 ’Demented / organic’; 29 ’functional’ not included in this review

Age 69.8 (range 38-95)

All residents in long-stay psychiatric hospital

Interventions RO groups

Diversional Occupational Therapy - group and individual

Outcomes Cognition: Royal College of Physicians mental test score

Behaviour: Crichton Behaviour Rating Scale

One month follow up data available

Notes 30 minutes, 5 times a week, for 3 months



Wallis 1983 (Continued)

Risk of bias



bias)

Low risk Drawing from a hat and consecutive allocation

Allocation concealment (selection bias) Low risk Drawing from a hat and consecutive allocation


bias)

All outcomes

Low risk Setting of treatment separate to assessment settings


bias)

All outcomes

Low risk Assessors unaware of group allocation


All outcomes

Unclear risk Eliminated those attending less than 20% of sessions; 12/31

participants in ’organic’ group lost i.e. 39%

Other bias Low risk Occupational therapists trained to carry out RO

Woods 1979

Methods RCT

Participants N = 18

’disorientated’, significant memory impairment

Age 76.6 (range 61-90)

All living in specialist residential homes for people with dementia

Interventions RO groups

Social Therapy groups

No treatment (in a different home, so not included in this review)

Outcomes Cognition: Wechsler Memory Scale; composite Information & Orientation test

Behaviour: modified Crichton Behaviour Rating Scale


Risk of bias



bias)

Low risk Stated that drawing from a hat was used



Woods 1979 (Continued)

Allocation concealment (selection bias) Unclear risk Stated that drawing from a hat was used


bias)

All outcomes

Low risk ’Social therapy’ was perceived by staff as an active therapy


bias)

All outcomes

Low risk Groups held in separate areas and assessors bind to group allo-

cation


All outcomes

Low risk 4/18 dropped out: i.e. 22.2% attrition

Other bias Low risk Checks were made in order to ensure compliance with thera-

peutic protocol, including rating tape-recorded sessions

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Arcoverde 2008 Intervention doesn’t meet the inclusion criteria for cognitive stimulation. Diagnoses varied, not purely

dementia

Basak 2008 Intervention described doesn’t meet the inclusion criteria for cognitive stimulation; better fit for

cognitive training

Brook 1975 Does not include a measure of cognitive function.

Carlson 2008 Intervention described doesn’t meet the inclusion criteria for cognitive stimulation but for cognitive

training. Diagnoses varied, not purely dementia

Cassinello 2008 Doesn’t report an RCT, reports results from Tarraga 2001.

Cheng 2006 Intervention described doesn’t meet the inclusion criteria for cognitive stimulation

Constantinidou 2008 Intervention described doesn’t meet the inclusion criteria for cognitive stimulation

Corbeil 1999 Although intervention is described as “cognitive stimulation”, it focuses on specific cognitive modal-

ities. Primary reports outcomes for family caregivers, no measure of cognitive function. Relates to

Quayhagen, 1995

Croisile 2006 Doesn’t report results from an RCT.

Davis 2001 Cognitive stimulation (delivered for 30 minutes a day, 6 days a week by family caregivers) confounded

with cognitive training-spaced retrieval and face name associations



(Continued)

Eckroth-Bucher 2009 Intervention doesn’t meet the inclusion criteria for cognitive stimulation. Diagnoses varied, not purely

dementia

Eggermont 2009a Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Eggermont 2009b Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Evans 2009 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Faggian 2007 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Fanto 2002 No mention of randomisation; available only as a conference abstract

Farina 2006a Non randomised allocation; comparison is with an active treatment group

Farina 2006b Non randomised allocation; comparison is with an active treatment group

Forbes 2004a Commentary on Spector 2003.

Gerber 1991 Eligible study, but no extractable data provided. Only data available is for a composite cognitive and

behavioural scale

Goldstein 1982 Around 25% of participants appear not to have dementia, other diagnoses include schizophrenia,

epilepsy and ruptured aneurysm

Gonzalez-Abraldes 2010 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Green 2009 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Greenaway 2008 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Hanley 1981 Eligible study, but no extractable data available

Hernandez, 2007 Reports on Requena 2006 study results. Article in Spanish.

Hirsch 2004 Reports on Spector 2003 results.

Holden 1978 Diagnoses varied, not purely dementia. Not clear that participants were randomised to the intervention

and control groups

Johnson 1981 Allocation of patients to treatment was not random for various practical reasons

Leach 2004 Commentary on Spector 2003.

Matsuda 2007 Non-randomised study.

Meza-Kubo 2009 Not a randomised control trial.



(Continued)

Milev 2008 Intervention doesn’t meet the inclusion criteria for cognitive stimulation - relates to ’snoezelen’

Moniz-Cook 2006 Reference to other studies in cognitive stimulation (e.g. Spector 2003) but not a new RCT

Mudge 2008 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Newson 2006 Intervention doesn’t meet the inclusion criteria for cognitive stimulation. Diagnoses varied, not de-

mentia

Olazaran 2004 12/84 participants with a diagnoses of MCI; results not presented separately for those with Alzheimer’s

disease.Interventions include additional elements as physical exercise

Orrell 2000b Describes study aims for Spector 2003.

Orrell 2005 Allocation to intervention and control groups not random for maintenance study

Quayhagen 1995 Although intervention is described as cognitive stimulation, it appears to focus on specific cognitive

modalities, and so fits better with cognitive training definition

Quayhagen 2000 Although intervention is described as cognitive stimulation, it appears to focus on specific cognitive

modalities, and so fits better with cognitive training definition

Raggi 2007 Not RCT.

Reeve 1985 No indication of random allocation to groups.

Riegler 1980 Comparin of RO plus music versus RO. No control groups without RO

Ruiz Sanchez de Leon 2007 No RCT and intervention doesn’t meet the criteria for inclusion under cognitive stimulation

Salmon 2006 No RCT, reports on Spector 2003 trial results.

Schmitter-Edgecombe 2008 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Schreiber 1998 Cognitive training, targeting specific cognitive modalities, rather than cognitive stimulation. Allocation

to groups alternate, not random

Schreiber 1999 See Schreiber 1998.

Scott 2003 Doesn’t report on a study intervention. No RCT.

Smith 2009 Intervention doesn’t meet the inclusion criteria for cognitive stimulation

Spector 2008 Reports on Spector 2003 results.



(Continued)

Tadaka 2004 The intervention combines elements of Reality Orientation (RO) and reminiscence. The RO element

appears to be only an orientation board, used to reinforce orientation for time, place and person. The

reminiscence element appears to be predominant, with a variety of reminiscence based triggers, and

so the study would be a better fit for a review of reminiscence work with people with dementia

Tarraga 2005a Published as Tarraga 2006.

Tarraga 2005b Published as Tarraga 2006.

Tarraga 2006 Allocation to groups is not entirely random. For the comparison of interest, integrated psychostimu-

lation program versus medication only control, allocation is clearly non-random

Tarraga 2007 As in Tarraga 2006.

Thickpenny-Davis 2007 Intervention doesn’t meet the inclusion criteria for cognitive stimulation, participants included with

other diagnosis than dementia

Tsai 2008 Not RCT.

Wenisch 2005 Participants included with a diagnosis of MCI and not dementia

Wenisch 2007 As in Wenisch 2005.

Wettstein 2004 Does not report an intervention study.

Williams 1987 Not a RCT, compares two wards, not cognitive stimulation, involves environmental modification and

informal RO

Woods 2006 Report on Spector 2003 study results.

Zanetti 1995 Allocation non-randomised.

Zanetti 2004 As in Zanetti 1995.

Zepelin 1981 Not a RCT, compares residents at one home with those in another

Zientz 2007 Does not report an intervention study.

Characteristics of studies awaiting assessment [ordered by study ID]



Buettner 2011

Methods RCT

Participants N=77 (15M/62F)

Community dwelling

Mild memory loss - probable early stage Alzheimer’s

MMSE 25.3

Interventions Classroom style ’Mentally Stimulating Activities’ v Structured early-stage social support programme

Outcomes Cognition: MMSE, Trail Making B

Quality of life: Cornell-Brown QoL

Depression: PHQ-9

Apathy Evaluation Scale

Notes Sessions 1 hour, twice weekly for 4 weeks

Fernandez-Calvo 2010

Methods RCT

Participants N=45

Probable Alzheimer’s

MMSE 18.97

Interventions Individual multimodal cognitive stimulation versus group multimodal cognitive stimulation versus no treatment

control

Outcomes Cognition: ADAS-Cog

NPI

Cornell Depression Scale

Notes In Spanish

Niu 2010

Methods RCT

Participants N=32

mild to moderate Alzheimer’s with marked neuropsychiatric symptoms

MMSE 17.1

Inpatients in military sanatorium

All on donepezil

Interventions Individual sessions, task based including reality orientation, fluency, and memory tasks

Placebo control - communication exercise

Outcomes Cognition: MMSE

NPI, apathy, depression



Niu 2010 (Continued)

Notes 45 minutes, twice a week for 10 weeks

Characteristics of ongoing studies [ordered by study ID]

Aguirre 2010

Trial name or title MCST - maintenance cognitive stimulation

Methods RCT

Participants Target N=230

Diagnosis of dementia with DSM-IV criteria

Mild to moderate dementia

Interventions All participants receive 7 weeks of twice weekly cognitive stimulation; then randomised to recive 6 months

of once weekly maintenance cognitive stimulation

Outcomes Cognition: ADAS-Cog, MMSE

Quality of Life: QoL-AD, DEMQOL

Starting date

Contact information [email protected]

Notes ISRCTN 26286067

Vidovich 2011

Trial name or title PACE-AD

Methods RCT

Participants Target N=128

probable Alzheimer’s

Interventions Cognitive activity groups for person with dementia and companion together v companions alone

Outcomes Cognition: ADAS-Cog

Companion quality of life, mood, and general health

Starting date

Contact information [email protected]

Notes Trial registration: ACTRN 12610000653066



D A T A A N D A N A L Y S E S

Comparison 1. Cognitive stimulation versus no cognitive stimulation: post-treatment

Outcome or subgroup titleNo. of

studies

No. of

participants Statistical method Effect size

1 Cognition 14 658 Std. Mean Difference (IV, Fixed, 95% CI) 0.41 [0.25, 0.57]

1.1 ADAS-Cog 7 434 Std. Mean Difference (IV, Fixed, 95% CI) 0.37 [0.17, 0.56]

1.2 Wechsler Memory Scale 1 10 Std. Mean Difference (IV, Fixed, 95% CI) 0.47 [-0.80, 1.74]

1.3 Global cognitive score

(includes MMSE & CERAD)

1 56 Std. Mean Difference (IV, Fixed, 95% CI) 0.63 [0.09, 1.17]

1.4 MMSE 2 110 Std. Mean Difference (IV, Fixed, 95% CI) 0.64 [0.17, 1.10]

1.5 CAPE-I/O 2 29 Std. Mean Difference (IV, Fixed, 95% CI) 0.29 [-0.48, 1.06]

1.6 RCP Cognition 1 19 Std. Mean Difference (IV, Fixed, 95% CI) 0.13 [-0.78, 1.03]

2 MMSE 10 Mean Difference (IV, Fixed, 95% CI) Subtotals only

2.1 One to twelve months of

CS

10 600 Mean Difference (IV, Fixed, 95% CI) 1.74 [1.13, 2.36]

2.2 24 months of CS 1 29 Mean Difference (IV, Fixed, 95% CI) 5.99 [-1.58, 13.56]

3 ADAS-Cog 7 Mean Difference (IV, Fixed, 95% CI) Subtotals only

3.1 One to twelve months of

CS

7 434 Mean Difference (IV, Fixed, 95% CI) 2.27 [0.99, 3.55]

3.2 24 months of CS 1 29 Mean Difference (IV, Fixed, 95% CI) 11.94 [-0.97, 24.85]

4 Other cognitive measure:

Information/Orientation

5 81 Std. Mean Difference (IV, Fixed, 95% CI) 0.45 [-0.01, 0.90]

4.1 CAPE I/O 2 29 Std. Mean Difference (IV, Fixed, 95% CI) 0.29 [-0.48, 1.06]

4.2 RCP Cognition 1 19 Std. Mean Difference (IV, Fixed, 95% CI) 0.13 [-0.78, 1.03]

4.3 Berg Orientation Scale 1 23 Std. Mean Difference (IV, Fixed, 95% CI) 0.87 [0.00, 1.74]

4.4 Information / Orientation 1 10 Std. Mean Difference (IV, Fixed, 95% CI) 0.60 [-0.68, 1.89]

5 Comunication and social

interaction


5.1 Holden Communication

Scale


5.2 MOSES - Withdrawn

behaviour


6 Well-being & Quality of Life 4 219 Std. Mean Difference (IV, Fixed, 95% CI) 0.38 [0.11, 0.65]

6.1 Life Satisfaction Index 1 10 Std. Mean Difference (IV, Fixed, 95% CI) -0.23 [-1.48, 1.01]

6.2 QoL-AD 3 209 Std. Mean Difference (IV, Fixed, 95% CI) 0.41 [0.13, 0.69]

7 Mood: Self-reported 5 201 Std. Mean Difference (IV, Fixed, 95% CI) 0.22 [-0.09, 0.53]

7.1 Geriatric Depression

Scale (GDS-30) One to twelve

months of CS


7.2 Geriatric Depression

Scale (14 item) One to twelve

months of CS

1 26 Std. Mean Difference (IV, Fixed, 95% CI) -0.39 [-1.16, 0.39]

7.3 Montgomery Asberg

Depression Rating Scale

(MADRS) One to twelve

months of CS


8 Mood: Staff-reported 4 239 Std. Mean Difference (IV, Fixed, 95% CI) 0.05 [-0.21, 0.31]



8.1 Cornell Scale for

Depression in Dementia


8.2 MOSES - Depressed /

anxious mood


8.3 Rating of Anxiety in

Dementia (RAID)


9 ADL scales 4 260 Std. Mean Difference (IV, Fixed, 95% CI) 0.21 [-0.05, 0.47]

10 Behaviour, general 8 416 Std. Mean Difference (IV, Fixed, 95% CI) 0.13 [-0.07, 0.32]

10.1 CAPE - BRS 4 231 Std. Mean Difference (IV, Fixed, 95% CI) 0.12 [-0.14, 0.38]

10.2 Crichton BRS (modified) 2 29 Std. Mean Difference (IV, Fixed, 95% CI) 0.33 [-0.42, 1.07]

10.3 MOSES Self-care 1 19 Std. Mean Difference (IV, Fixed, 95% CI) 0.00 [-0.97, 0.97]

10.4 Instrumental ADL 1 137 Std. Mean Difference (IV, Fixed, 95% CI) 0.12 [-0.22, 0.46]

11 Behaviour, problem 3 166 Std. Mean Difference (IV, Fixed, 95% CI) -0.14 [-0.44, 0.17]

11.1 Problem Behaviour

Rating Scale


11.2 MOSES - Irritable 1 19 Std. Mean Difference (IV, Fixed, 95% CI) 0.12 [-0.85, 1.09]

11.3 NPI 1 137 Std. Mean Difference (IV, Fixed, 95% CI) -0.20 [-0.54, 0.13]

12 Caregiver outcome 3 Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only

12.1 Hamilton anxiety 2 150 Std. Mean Difference (IV, Fixed, 95% CI) 0.11 [-0.21, 0.44]

12.2 Depression 2 150 Std. Mean Difference (IV, Fixed, 95% CI) 0.04 [-0.28, 0.36]

12.3 Carer stress/burden 2 147 Std. Mean Difference (IV, Fixed, 95% CI) -0.03 [-0.35, 0.29]

12.4 General Health

Questionnaire (GHQ-12)


Comparison 2. Cognitive stimulation versus no cognitive stimulation: follow-up

Outcome or subgroup titleNo. of

studies

No. of

participants Statistical method Effect size

1 Cognition 4 Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only

1.1 One to three months

follow-up Information/

Orientation


1.2 Ten months follow-up

MMSE



ADAS-Cog


2 Well-being & Quality of Life 2 Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only

2.1 One month follow-up Life

Satisfaction Index



QoL-AD


3 Behaviour, general 3 Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only

3.1 One month follow-up 2 29 Std. Mean Difference (IV, Fixed, 95% CI) 0.44 [-0.30, 1.18]


Texas Functional Living Scale


4 Behaviour, problem 2 Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only



4.1 One month follow-up

Problem Behaviour Rating

Scale


4.2 Ten month follow-up NPI

severity


4.3 Ten-month follow up NPI

(Caregiver Distress)


5 Communication and social

interaction

2 Std. Mean Difference (IV, Fixed, 95% CI) Subtotals only

5.1 One month follow-up

Holden Communication Scale


5.2 Ten month follow-up

’Relevance of discourse’


Analysis 1.1. Comparison 1 Cognitive stimulation versus no cognitive stimulation: post-treatment,

Outcome 1 Cognition.

Review: Cognitive stimulation to improve cognitive functioning in people with dementia

Comparison: 1 Cognitive stimulation versus no cognitive stimulation: post-treatment

Outcome: 1 Cognition

Study or subgroup Cognitive stimulation Control

Std.Mean

Difference Weight

Std.Mean

Difference

N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 ADAS-Cog

Bottino 2005 6 2.17 (8.33) 7 -0.43 (8.92) 2.1 % 0.28 [ -0.82, 1.38 ]

Buschert 2011 8 0.7 (8) 7 0 (6.93) 2.5 % 0.09 [ -0.93, 1.10 ]

Coen 2011 13 0.2 (7.2) 12 2.3 (4.1) 4.1 % -0.34 [ -1.13, 0.45 ]

Onder 2005 70 0.4 (6.69) 67 -2.5 (6.55) 22.5 % 0.44 [ 0.10, 0.77 ]

Requena 2006 20 6.4 (14.06) 30 -6.6 (20.48) 7.6 % 0.70 [ 0.12, 1.29 ]

Spector 2001 17 4.3 (17.33) 10 -1 (20.5) 4.2 % 0.28 [ -0.51, 1.06 ]

Spector 2003 97 1.9 (6.2) 70 -0.3 (5.5) 26.9 % 0.37 [ 0.06, 0.68 ]

Subtotal (95% CI) 231 203 70.0 % 0.37 [ 0.17, 0.56 ]

Heterogeneity: Chi2 = 4.88, df = 6 (P = 0.56); I2 =0.0%

Test for overall effect: Z = 3.74 (P = 0.00019)

2 Wechsler Memory Scale

Woods 1979 5 4.7 (12.02) 5 -0.6 (7.85) 1.6 % 0.47 [ -0.80, 1.74 ]

Subtotal (95% CI) 5 5 1.6 % 0.47 [ -0.80, 1.74 ]

Heterogeneity: not applicable

-4 -2 0 2 4

Favours control Favours CS

(Continued . . . )



(. . . Continued)


Std.Mean

Difference Weight

Std.Mean

Difference



3 Global cognitive score (includes MMSE % CERAD)

Breuil 1994 29 5.8 (7.3) 27 1 (7.8) 8.9 % 0.63 [ 0.09, 1.17 ]

Subtotal (95% CI) 29 27 8.9 % 0.63 [ 0.09, 1.17 ]



4 MMSE

Baldelli 1993a 13 3 (5.32) 10 -4.4 (9.15) 3.3 % 0.99 [ 0.11, 1.87 ]

Baldelli 2002 71 2.34 (4.78) 16 -0.12 (5.06) 8.6 % 0.50 [ -0.04, 1.05 ]

Subtotal (95% CI) 84 26 11.9 % 0.64 [ 0.17, 1.10 ]



5 CAPE-I/O

Baines 1987 5 1.4 (4.59) 5 0.1 (6.4) 1.7 % 0.21 [ -1.03, 1.46 ]

Ferrario 1991 13 1.23 (3.64) 6 0 (2.93) 2.7 % 0.34 [ -0.63, 1.32 ]

Subtotal (95% CI) 18 11 4.4 % 0.29 [ -0.48, 1.06 ]



6 RCP Cognition

Wallis 1983 10 5.9 (35.5) 9 1.7 (27.04) 3.2 % 0.13 [ -0.78, 1.03 ]

Subtotal (95% CI) 10 9 3.2 % 0.13 [ -0.78, 1.03 ]



Total (95% CI) 377 281 100.0 % 0.41 [ 0.25, 0.57 ]


Test for overall effect: Z = 5.04 (P < 0.00001)

Test for subgroup differences: Chi2 = 2.24, df = 5 (P = 0.82), I2 =0.0%

-4 -2 0 2 4





Outcome 2 MMSE.



Outcome: 2 MMSE

Study or subgroup Cognitive stimulation ControlMean

Difference WeightMean

Difference


1 One to twelve months of CS

Baldelli 1993a 13 3 (5.32) 10 -4.4 (9.15) 0.9 % 7.40 [ 1.03, 13.77 ]

Baldelli 2002 71 2.34 (4.78) 16 -0.12 (5.06) 5.1 % 2.46 [ -0.26, 5.18 ]

Bottino 2005 6 0.83 (4.53) 7 -1.43 (5.3) 1.3 % 2.26 [ -3.08, 7.60 ]

Breuil 1994 29 1.4 (2.7) 27 -0.7 (3.1) 16.1 % 2.10 [ 0.57, 3.63 ]

Buschert 2011 8 0.5 (3.14) 7 -0.9 (2.83) 4.1 % 1.40 [ -1.62, 4.42 ]

Coen 2011 14 0.8 (3.6) 11 -2.1 (2.5) 6.6 % 2.90 [ 0.50, 5.30 ]

Onder 2005 70 0.2 (3.35) 67 -1.1 (3.27) 30.6 % 1.30 [ 0.19, 2.41 ]

Requena 2006 20 1.5 (7.38) 30 -3.37 (10.71) 1.5 % 4.87 [ -0.14, 9.88 ]

Spector 2001 17 3.1 (7.04) 10 0 (7.04) 1.2 % 3.10 [ -2.40, 8.60 ]

Spector 2003 97 0.9 (3.5) 70 -0.4 (3.5) 32.5 % 1.30 [ 0.22, 2.38 ]

Subtotal (95% CI) 345 255 100.0 % 1.74 [ 1.13, 2.36 ]


Test for overall effect: Z = 5.57 (P < 0.00001)

2 24 months of CS

Requena 2006 14 -1.31 (10.3) 15 -7.3 (10.5) 100.0 % 5.99 [ -1.58, 13.56 ]

Subtotal (95% CI) 14 15 100.0 % 5.99 [ -1.58, 13.56 ]



Test for subgroup differences: Chi2 = 1.20, df = 1 (P = 0.27), I2 =17%

-20 -10 0 10 20





Outcome 3 ADAS-Cog.



Outcome: 3 ADAS-Cog

Study or subgroup Cognitive stimulation ControlMean

Difference WeightMean

Difference


1 One to twelve months of CS

Bottino 2005 6 2.17 (8.33) 7 -0.43 (8.92) 1.9 % 2.60 [ -6.79, 11.99 ]

Buschert 2011 8 0.7 (8) 7 0 (6.93) 2.9 % 0.70 [ -6.86, 8.26 ]

Coen 2011 13 0.2 (7.2) 12 2.3 (4.1) 7.9 % -2.10 [ -6.65, 2.45 ]

Onder 2005 70 0.4 (6.69) 67 -2.5 (6.55) 33.3 % 2.90 [ 0.68, 5.12 ]

Requena 2006 20 6.4 (14.06) 30 -6.6 (20.48) 1.8 % 13.00 [ 3.43, 22.57 ]

Spector 2001 17 4.3 (17.33) 10 -1 (20.5) 0.7 % 5.30 [ -9.84, 20.44 ]

Spector 2003 97 1.9 (6.2) 70 -0.3 (5.5) 51.5 % 2.20 [ 0.42, 3.98 ]

Subtotal (95% CI) 231 203 100.0 % 2.27 [ 0.99, 3.55 ]

Heterogeneity: Chi2 = 9.01, df = 6 (P = 0.17); I2 =33%


2 24 months of CS

Requena 2006 14 3.38 (18.26) 15 -8.56 (17.13) 100.0 % 11.94 [ -0.97, 24.85 ]

Subtotal (95% CI) 14 15 100.0 % 11.94 [ -0.97, 24.85 ]




-20 -10 0 10 20





Outcome 4 Other cognitive measure: Information/Orientation.



Outcome: 4 Other cognitive measure: Information/Orientation


Std.Mean

Difference Weight

Std.Mean

Difference


1 CAPE I/O

Baines 1987 5 1.4 (4.59) 5 0.1 (6.4) 13.3 % 0.21 [ -1.03, 1.46 ]

Ferrario 1991 13 1.23 (3.64) 6 0 (2.93) 21.7 % 0.34 [ -0.63, 1.32 ]

Subtotal (95% CI) 18 11 35.0 % 0.29 [ -0.48, 1.06 ]



2 RCP Cognition

Wallis 1983 10 5.9 (35.5) 9 1.7 (27.04) 25.3 % 0.13 [ -0.78, 1.03 ]

Subtotal (95% CI) 10 9 25.3 % 0.13 [ -0.78, 1.03 ]



3 Berg Orientation Scale

Baldelli 1993a 13 2.6 (3.47) 10 -0.8 (4.1) 27.2 % 0.87 [ 0.00, 1.74 ]

Subtotal (95% CI) 13 10 27.2 % 0.87 [ 0.00, 1.74 ]



4 Information / Orientation

Woods 1979 5 4 (6.11) 5 0.1 (5.52) 12.5 % 0.60 [ -0.68, 1.89 ]

Subtotal (95% CI) 5 5 12.5 % 0.60 [ -0.68, 1.89 ]



Total (95% CI) 46 35 100.0 % 0.45 [ -0.01, 0.90 ]




-4 -2 0 2 4





Outcome 5 Comunication and social interaction.



Outcome: 5 Comunication and social interaction


Std.Mean

Difference Weight

Std.Mean

Difference


1 Holden Communication Scale

Baines 1987 5 2 (7.56) 5 -2.6 (12.5) 4.7 % 0.40 [ -0.86, 1.66 ]

Spector 2001 17 -0.7 (10.5) 10 -0.5 (9.4) 12.1 % -0.02 [ -0.80, 0.76 ]

Spector 2003 97 0.2 (6.1) 70 -3.2 (6.3) 75.4 % 0.55 [ 0.23, 0.86 ]

Subtotal (95% CI) 119 85 92.1 % 0.47 [ 0.18, 0.75 ]



2 MOSES - Withdrawn behaviour

Ferrario 1991 13 1.31 (6.31) 6 0.5 (9.44) 7.9 % 0.10 [ -0.86, 1.07 ]

Subtotal (95% CI) 13 6 7.9 % 0.10 [ -0.86, 1.07 ]



Total (95% CI) 132 91 100.0 % 0.44 [ 0.17, 0.71 ]




-10 -5 0 5 10





Outcome 6 Well-being & Quality of Life.



Outcome: 6 Well-being % Quality of Life

Study or subgroup Cognitive Stimulation Control

Std.Mean

Difference Weight

Std.Mean

Difference


1 Life Satisfaction Index

Baines 1987 5 -1.2 (6.09) 5 0.2 (4.64) 4.7 % -0.23 [ -1.48, 1.01 ]

Subtotal (95% CI) 5 5 4.7 % -0.23 [ -1.48, 1.01 ]



2 QoL-AD

Buschert 2011 8 -0.4 (10.61) 7 -0.9 (5.52) 7.1 % 0.05 [ -0.96, 1.07 ]

Coen 2011 14 3.6 (3.7) 13 0.5 (4.4) 11.9 % 0.74 [ -0.04, 1.53 ]

Spector 2003 97 1.3 (5.1) 70 -0.8 (5.6) 76.2 % 0.39 [ 0.08, 0.70 ]

Subtotal (95% CI) 119 90 95.3 % 0.41 [ 0.13, 0.69 ]



Total (95% CI) 124 95 100.0 % 0.38 [ 0.11, 0.65 ]




-2 -1 0 1 2





Outcome 7 Mood: Self-reported.



Outcome: 7 Mood: Self-reported


Std.Mean

Difference Weight

Std.Mean

Difference


1 Geriatric Depression Scale (GDS-30) One to twelve months of CS

Baldelli 1993a 13 2.1 (4.61) 10 -2.3 (4.99) 12.7 % 0.89 [ 0.02, 1.76 ]

Baldelli 2002 71 3.21 (7.98) 16 2.57 (10) 32.7 % 0.08 [ -0.47, 0.62 ]

Requena 2006 20 5.6 (7.87) 30 2.03 (9.07) 29.4 % 0.41 [ -0.16, 0.98 ]

Subtotal (95% CI) 104 56 74.8 % 0.34 [ -0.01, 0.70 ]



2 Geriatric Depression Scale (14 item) One to twelve months of CS

Coen 2011 13 -0.9 (3) 13 0.1 (1.9) 15.9 % -0.39 [ -1.16, 0.39 ]

Subtotal (95% CI) 13 13 15.9 % -0.39 [ -1.16, 0.39 ]



3 Montgomery Asberg Depression Rating Scale (MADRS) One to twelve months of CS

Buschert 2011 8 1.5 (5.33) 7 -0.4 (6.4) 9.2 % 0.31 [ -0.72, 1.33 ]

Subtotal (95% CI) 8 7 9.2 % 0.31 [ -0.72, 1.33 ]



Total (95% CI) 125 76 100.0 % 0.22 [ -0.09, 0.53 ]




-2 -1 0 1 2





Outcome 8 Mood: Staff-reported.



Outcome: 8 Mood: Staff-reported


Std.Mean

Difference Weight

Std.Mean

Difference


1 Cornell Scale for Depression in Dementia

Spector 2001 17 2.6 (8.05) 10 -2.2 (7.19) 10.5 % 0.60 [ -0.20, 1.40 ]

Spector 2003 97 0 (6.2) 70 0.5 (7) 71.2 % -0.08 [ -0.38, 0.23 ]

Subtotal (95% CI) 114 80 81.7 % 0.01 [ -0.28, 0.30 ]



2 MOSES - Depressed / anxious mood

Ferrario 1991 13 1.08 (9.5) 6 1.17 (4.62) 7.2 % -0.01 [ -0.98, 0.96 ]

Subtotal (95% CI) 13 6 7.2 % -0.01 [ -0.98, 0.96 ]



3 Rating of Anxiety in Dementia (RAID)

Coen 2011 14 1.1 (7.3) 12 -1.6 (6.4) 11.1 % 0.38 [ -0.40, 1.16 ]

Subtotal (95% CI) 14 12 11.1 % 0.38 [ -0.40, 1.16 ]



Total (95% CI) 141 98 100.0 % 0.05 [ -0.21, 0.31 ]




-2 -1 0 1 2





Outcome 9 ADL scales.



Outcome: 9 ADL scales


Std.Mean

Difference Weight

Std.Mean

Difference


Baldelli 1993a 13 1.5 (39.47) 10 -8.9 (39.2) 10.0 % 0.25 [ -0.57, 1.08 ]

Baldelli 2002 71 15.37 (34.94) 16 11.88 (40.48) 23.4 % 0.10 [ -0.45, 0.64 ]

Bottino 2005 6 1 (3.27) 7 0.15 (2.86) 5.7 % 0.26 [ -0.84, 1.36 ]

Onder 2005 70 -0.9 (8.37) 67 -2.9 (8.19) 60.9 % 0.24 [ -0.10, 0.58 ]

Total (95% CI) 160 100 100.0 % 0.21 [ -0.05, 0.47 ]



Test for subgroup differences: Not applicable

-1 -0.5 0 0.5 1





Outcome 10 Behaviour, general.



Outcome: 10 Behaviour, general


Std.Mean

Difference Weight

Std.Mean

Difference


1 CAPE - BRS

Baines 1987 5 4.8 (3.87) 5 -1.2 (9.37) 2.2 % 0.76 [ -0.55, 2.07 ]

Coen 2011 14 0 (3.6) 13 -1.4 (5.4) 6.6 % 0.30 [ -0.46, 1.06 ]

Spector 2001 17 -1.1 (6.08) 10 -0.6 (7.07) 6.2 % -0.08 [ -0.86, 0.71 ]

Spector 2003 97 -0.2 (6.1) 70 -0.7 (5.5) 40.2 % 0.08 [ -0.22, 0.39 ]

Subtotal (95% CI) 133 98 55.3 % 0.12 [ -0.14, 0.38 ]



2 Crichton BRS (modified)

Wallis 1983 10 -0.3 (24.92) 9 -2.4 (21.28) 4.7 % 0.09 [ -0.81, 0.99 ]

Woods 1979 5 -1 (5.06) 5 -5.2 (3.82) 2.2 % 0.85 [ -0.48, 2.17 ]

Subtotal (95% CI) 15 14 6.8 % 0.33 [ -0.42, 1.07 ]



3 MOSES Self-care

Ferrario 1991 13 -0.31 (9.88) 6 -0.33 (5.89) 4.1 % 0.00 [ -0.97, 0.97 ]

Subtotal (95% CI) 13 6 4.1 % 0.00 [ -0.97, 0.97 ]



4 Instrumental ADL

Onder 2005 70 0 (1.67) 67 -0.2 (1.64) 33.8 % 0.12 [ -0.22, 0.46 ]

Subtotal (95% CI) 70 67 33.8 % 0.12 [ -0.22, 0.46 ]



Total (95% CI) 231 185 100.0 % 0.13 [ -0.07, 0.32 ]




-2 -1 0 1 2





Outcome 11 Behaviour, problem.



Outcome: 11 Behaviour, problem


Std.Mean

Difference Weight

Std.Mean

Difference


1 Problem Behaviour Rating Scale

Baines 1987 5 3.6 (11.4) 5 -1.8 (12.8) 6.0 % 0.40 [ -0.86, 1.66 ]

Subtotal (95% CI) 5 5 6.0 % 0.40 [ -0.86, 1.66 ]



2 MOSES - Irritable

Ferrario 1991 13 0.69 (2.45) 6 0.16 (6.89) 10.1 % 0.12 [ -0.85, 1.09 ]

Subtotal (95% CI) 13 6 10.1 % 0.12 [ -0.85, 1.09 ]



3 NPI

Onder 2005 70 -0.9 (15.9) 67 2.5 (17.19) 83.9 % -0.20 [ -0.54, 0.13 ]

Subtotal (95% CI) 70 67 83.9 % -0.20 [ -0.54, 0.13 ]



Total (95% CI) 88 78 100.0 % -0.14 [ -0.44, 0.17 ]




-4 -2 0 2 4





Outcome 12 Caregiver outcome.



Outcome: 12 Caregiver outcome


Std.Mean

Difference Weight

Std.Mean

Difference


1 Hamilton anxiety

Bottino 2005 6 4.83 (6.33) 7 0.14 (5.41) 7.9 % 0.75 [ -0.40, 1.89 ]

Onder 2005 70 -0.3 (3.35) 67 -0.5 (3.27) 92.1 % 0.06 [ -0.27, 0.40 ]

Subtotal (95% CI) 76 74 100.0 % 0.11 [ -0.21, 0.44 ]



2 Depression

Bottino 2005 6 3.83 (7.71) 7 2.29 (7.69) 8.6 % 0.19 [ -0.91, 1.28 ]

Onder 2005 70 -0.9 (3.35) 67 -1 (3.27) 91.4 % 0.03 [ -0.30, 0.37 ]

Subtotal (95% CI) 76 74 100.0 % 0.04 [ -0.28, 0.36 ]



3 Carer stress/burden

Onder 2005 70 -2 (11.7) 67 -1.3 (12.3) 93.3 % -0.06 [ -0.39, 0.28 ]

Spector 2001 5 -1 (12.8) 5 -9 (26.6) 6.7 % 0.35 [ -0.91, 1.60 ]

Subtotal (95% CI) 75 72 100.0 % -0.03 [ -0.35, 0.29 ]



4 General Health Questionnaire (GHQ-12)

Spector 2001 5 3.8 (2.91) 5 -0.3 (4.75) 100.0 % 0.94 [ -0.41, 2.29 ]

Subtotal (95% CI) 5 5 100.0 % 0.94 [ -0.41, 2.29 ]




-2 -1 0 1 2




Analysis 2.1. Comparison 2 Cognitive stimulation versus no cognitive stimulation: follow-up, Outcome 1

Cognition.


Comparison: 2 Cognitive stimulation versus no cognitive stimulation: follow-up

Outcome: 1 Cognition


Std.Mean

Difference Weight

Std.Mean

Difference


1 One to three months follow-up Information/ Orientation

Baines 1987 5 -0.2 (4.46) 5 -2.3 (5.94) 20.0 % 0.36 [ -0.90, 1.62 ]

Baldelli 1993a 13 1.4 (3.75) 10 -2 (3.96) 41.9 % 0.85 [ -0.01, 1.72 ]

Wallis 1983 10 8.5 (36.6) 9 -4.9 (30.7) 38.1 % 0.38 [ -0.53, 1.29 ]

Subtotal (95% CI) 28 24 100.0 % 0.57 [ 0.01, 1.14 ]



2 Ten months follow-up MMSE

Chapman 2004 26 -1.25 (3.98) 28 -2.14 (5.51) 100.0 % 0.18 [ -0.35, 0.72 ]

Subtotal (95% CI) 26 28 100.0 % 0.18 [ -0.35, 0.72 ]



3 Ten months follow-up ADAS-Cog

Chapman 2004 26 -4.89 (5.78) 28 -5.62 (6.02) 100.0 % 0.12 [ -0.41, 0.66 ]

Subtotal (95% CI) 26 28 100.0 % 0.12 [ -0.41, 0.66 ]




-2 -1 0 1 2





Well-being & Quality of Life.



Outcome: 2 Well-being % Quality of Life


Std.Mean

Difference Weight

Std.Mean

Difference


1 One month follow-up Life Satisfaction Index

Baines 1987 5 -1.6 (3.85) 5 -1.4 (7.44) 100.0 % -0.03 [ -1.27, 1.21 ]

Subtotal (95% CI) 5 5 100.0 % -0.03 [ -1.27, 1.21 ]



2 Ten months follow-up QoL-AD

Chapman 2004 26 2.05 (5.98) 28 -0.1 (6.29) 100.0 % 0.34 [ -0.19, 0.88 ]

Subtotal (95% CI) 26 28 100.0 % 0.34 [ -0.19, 0.88 ]




-4 -2 0 2 4





Behaviour, general.



Outcome: 3 Behaviour, general


Std.Mean

Difference Weight

Std.Mean

Difference


1 One month follow-up

Baines 1987 5 3.5 (5.21) 5 0 (5.51) 33.5 % 0.59 [ -0.69, 1.87 ]

Wallis 1983 10 5.9 (28.15) 9 -3.7 (20.83) 66.5 % 0.37 [ -0.54, 1.28 ]

Subtotal (95% CI) 15 14 100.0 % 0.44 [ -0.30, 1.18 ]



2 Ten months follow-up Texas Functional Living Scale

Chapman 2004 26 -2.89 (7.21) 28 -6.86 (10.42) 100.0 % 0.43 [ -0.11, 0.97 ]

Subtotal (95% CI) 26 28 100.0 % 0.43 [ -0.11, 0.97 ]




-4 -2 0 2 4





Behaviour, problem.



Outcome: 4 Behaviour, problem


Std.Mean

Difference Weight

Std.Mean

Difference


1 One month follow-up Problem Behaviour Rating Scale

Baines 1987 5 5 (10.88) 5 0.2 (11.12) 100.0 % 0.39 [ -0.87, 1.65 ]

Subtotal (95% CI) 5 5 100.0 % 0.39 [ -0.87, 1.65 ]



2 Ten month follow-up NPI severity

Chapman 2004 26 2.25 (14.33) 28 -2.19 (15.33) 100.0 % 0.29 [ -0.24, 0.83 ]

Subtotal (95% CI) 26 28 100.0 % 0.29 [ -0.24, 0.83 ]



3 Ten-month follow up NPI (Caregiver Distress)

Chapman 2004 26 1.35 (6.19) 28 -2.1 (9.86) 100.0 % 0.41 [ -0.13, 0.95 ]

Subtotal (95% CI) 26 28 100.0 % 0.41 [ -0.13, 0.95 ]




-4 -2 0 2 4





Communication and social interaction.



Outcome: 5 Communication and social interaction


Std.Mean

Difference Weight

Std.Mean

Difference


1 One month follow-up Holden Communication Scale

Baines 1987 5 3.4 (6.43) 5 1.2 (12.81) 100.0 % 0.20 [ -1.05, 1.44 ]

Subtotal (95% CI) 5 5 100.0 % 0.20 [ -1.05, 1.44 ]



2 Ten month follow-up ’Relevance of discourse’

Chapman 2004 26 -3.35 (11.11) 28 -5.05 (11.85) 100.0 % 0.15 [ -0.39, 0.68 ]

Subtotal (95% CI) 26 28 100.0 % 0.15 [ -0.39, 0.68 ]




-4 -2 0 2 4


A P P E N D I C E S

Appendix 1. Search: December 2011

Source Search strategy Hits retrieved

1. ALOIS (www.medicine.ox.ac.uk/alois)

(all dates)

cognitive stimulation OR reality orienta-

tion OR memory therapy OR memory

groups OR memory support OR mem-

ory stimulation OR global stimulation OR

cognitive psychostimulation

139



(Continued)

2. MEDLINE In-process and other non-

indexed citations and MEDLINE 1950-

present (Ovid SP)

1. exp Dementia/

2. Delirium/

3. Wernicke Encephalopathy/

4. Delirium, Dementia, Amnestic, Cogni-

tive Disorders/

5. dement*.mp.

6. alzheimer*.mp.

7. (lewy* adj2 bod*).mp.

8. deliri*.mp.

9. (chronic adj2 cerebrovascular).mp.

10. (“organic brain disease” or “organic

brain syndrome”).mp

11. (“normal pressure hydrocephalus” and

“shunt*”).mp.

12. “benign senescent forgetfulness”.mp.

13. (cerebr* adj2 deteriorat*).mp.

14. (cerebral* adj2 insufficient*).mp.

15. (pick* adj2 disease).mp.

16. (creutzfeldt or jcd or cjd).mp.

17. huntington*.mp.

18. binswanger*.mp.

19. korsako*.mp.

20. or/1-19

21. “cognitiv* stimul*”.mp.

22. “reality orientation”.mp.

23. (memory adj2 therapy).mp.

24. “memory group*”.mp.

25. “memory support”.mp.

26. (memory adj2 stimulat*).mp.

27. “global stimulation”.mp.

28. (“cognitive psycho-stimulation” or

“cognitive psychostimulation”).mp

29. *Psychomotor Performance/

30. or/21-29

31. 20 and 30

32. (2010* OR 2011*).ed.

33. 31 and 32

34. randomized controlled trial.pt.

35. controlled clinical trial.pt.

36. randomized.ab.

37. placebo.ab.

38. drug therapy.fs.

39. randomly.ab.

40. trial.ab.

41. groups.ab.

42. or/34-41

43. (animals not (humans and animals)).

40



(Continued)

sh.

44. 42 not 43

45. 33 and 44

3. EMBASE

1980-2011 Dec 05 (Ovid SP)

1. exp dementia/

2. Lewy body/

3. delirium/

4. Wernicke encephalopathy/

5. cognitive defect/

6. dement*.mp.

7. alzheimer*.mp.


9. deliri*.mp.




12. “supranuclear palsy”.mp.


“shunt*”).mp.






19. huntington*.mp.

20. binswanger*.mp.

21. korsako*.mp.

22. CADASIL.mp.

23. or/1-22










32. *psychomotor performance/

33. or/24-32

34. 23 and 33

35. (2010* OR 2011*).em.

36. 34 and 35

239

4. PsycINFO

1806-November week 5 2011 (Ovid SP)

1. exp Dementia/

2. exp Delirium/

3. exp Huntingtons Disease/

4. exp Kluver Bucy Syndrome/

5. exp Wernickes Syndrome/

6. exp Cognitive Impairment/

29



(Continued)

7. dement*.mp.

8. alzheimer*.mp.


10. deliri*.mp.




13. “supranuclear palsy”.mp.


“shunt*”).mp.






20. huntington*.mp.

21. binswanger*.mp.

22. korsako*.mp.

23. (“parkinson* disease dementia” or PDD

or “parkinson* dementia”).mp

24. or/1-23










33. “psychomotor performance”.mp.

34. or/25-33

35. 24 and 34

36. random*.mp.

37. trial.mp.

38. placebo.mp.

39. group*.mp.

40. exp Clinical Trials/

41. or/36-40

42. 35 and 41

43. (2010* OR 2011*).up.

44. 42 and 43

5. CINAHL (EBSCOhost) S1 (MH “Dementia+”)

S2 (MH “Delirium”) or (MH “Delir-

ium, Dementia, Amnestic, Cognitive Dis-

orders”)

S3 (MH “Wernicke’s Encephalopathy”)

S4 TX dement*

S5 TX alzheimer*

34



(Continued)

S6 TX lewy* N2 bod*

S7 TX deliri*

S8 TX chronic N2 cerebrovascular

S9 TX “organic brain disease” or “organic

brain syndrome”

S10 TX “normal pressure hydrocephalus”

and “shunt*”

S11 TX “benign senescent forgetfulness”

S12 TX cerebr* N2 deteriorat*

S13 TX cerebral* N2 insufficient*

S14 TX pick* N2 disease

S15 TX creutzfeldt or jcd or cjd

S16 TX huntington*

S17 TX binswanger*

S18 TX korsako*

S19 S1 or S2 or S3 or S4 or S5 or S6 or S7

or S8 or S9 or S10 or S11 or S12 or S13 or

S14 or S15 or S16 or S17 or S18

S20 TX “cognitiv* stimul*”

S21 TX “reality orientation”

S22 TX memory N2 therapy

S23 TX “memory group*”

S24 TX “memory support”

S25 TX memory N2 stimulat*

S26 TX “global stimulation”

S27 TX “cognitive psycho-stimulation”

OR “cognitive psychostimulation”

S28 (MM “Psychomotor Performance”)

S29 S20 or S21 or S22 or S23 or S24 or

S25 or S26 or S27 or S28

S30 S19 and S29

S31 EM 2010

S32 EM 2011

S33 S31 or S32

S34 S30 and S33

S35 TX random*

S36 (MH “Clinical Trials+”)

S37 AB group

S38 TI study

S39 S35 or S36 or S37 or S38

S40 S34 and S39

6. Web of Science (1945-present) (WOK) Topic=(dement* OR alzheimer* OR “lew*

bod*” OR deliri* OR creutzfeldt OR cjd

OR jcd OR huntington* OR binswanger*

OR korsako*) AND Topic=(“cognitiv*

stimul*” OR CST OR “reality orien-

ation” OR “memory therapy” OR “mem-

ory group*” OR “memory support” OR

135



(Continued)

“psychomotor performance” OR “global

stimulation” OR “cognitive performance”)

AND Topic=(random* OR trial* OR RCT

OR “cross-over” OR cross-over) AND Year

Published=(2010-2011)

Timespan=All Years. Databases=

SCI-EXPANDED, SSCI, A&HCI, CPCI-

S, CPCI-SSH

Lemmatization=On

7. LILACS (BIREME) “cognitiv$ stimul$” OR “reality orien-

ation” OR “memory therapy” OR “mem-

ory group$” OR “memory support” OR

“psychomotor performance” OR “global

stimulation” OR “cognitive performance”

[Words] and dementia OR alzheimer$ OR

demenc$ OR AD OR demência [Words]

16

8. CENTRAL (The Cochrane Library) (Is-

sue 3 of 4, Oct 2011)

#1 dement*

#2 alzheimer*

#3 deliri*

#4 chronic adj2 cerebrovascular

#5 (lewy* bod*)

#6 “organic brain disease” or “organic brain

syndrome”

#7 (pick* disease)

#8 creutzfeldt or jcd or cjd

#9 huntington*

#10 binswanger*

#11 korsako*

#12 (#1 OR #2 OR #3 OR #4 OR #5 OR

#6 OR #7 OR #8 OR #9 OR #10 OR #

11)

#13 “cognitiv* stimul*”

#14 “reality orientation”

#15 “memory therapy”

#16 “memory group*”

#17 “memory support”

#18 “memory stimulat*”

#19 “global stimulation”

#20 “cognitive psycho-stimulation”

#21 “cognitive psychostimulation”

#22 MeSH descriptor Psychomotor Perfor-

mance explode all trees

#23 (#13 OR #14 OR #15 OR #16 OR #

17 OR #18 OR #19 OR #20 OR #21 OR

#22)

#24 (#12 AND #23)

35



(Continued)

#25 (#24), from 2010 to 2011

9. Clinicaltrials.gov (

www.clinicaltrials.gov)

#1 Intervention: Cognitive stimulation

AND Interventional studies AND First rec:

01/01/2010-12/05/2011 = 30

#2 Intervention: reality orientation AND

Interventional studies AND First rec: 01/

01/2010-12/05/2011 = 1

#3 Interventional Studies | dementia OR

alzheimers OR AD OR alzheimer’s OR

alzheimer OR lewy OR FTLD OR FLD

| memory therapy OR memory training |

received from 01/01/2010 to 12/05/2011=

20

51

10. ICTRP Search Portal (http:/

/apps.who.int/trialsearch) [includes: Aus-

tralian New Zealand Clinical Trials Reg-

istry; ClinicalTrilas.gov; ISRCTN; Chinese

Clinical Trial Registry; Clinical Trials Reg-

istry - India; Clinical Research Informa-

tion Service - Republic of Korea; German

Clinical Trials Register; Iranian Registry

of Clinical Trials; Japan Primary Registries

Network; Pan African Clinical Trial Reg-

istry; Sri Lanka Clinical Trials Registry; The

Netherlands National Trial Register]

Advanced search: (dementia OR alzheimer

OR alzheimers OR alzheimers) AND (cog-

nitive stimulation OR reality orientation

OR memory therapy OR memory training

OR cognitive training) AND (2010-2011)

86

TOTAL before de-duplication 804

TOTAL after de-dupe and first-assess 41

H I S T O R Y

Protocol first published: Issue 4, 2005

Review first published: Issue 2, 2012



http://www.clinicaltrials.gov/

http://apps.who.int/trialsearch




C O N T R I B U T I O N S O F A U T H O R S

BW: correspondence; drafting review versions; search for trials; selection of trials; extraction of data; entry of data; data analysis;

interpretation of data analyses; updating review.

AS: selection of trials; extraction of data; interpretation of data analyses; updating review.

EA: search for trials; obtaining copies of trial reports; entry of data; data analysis; interpretation of data analyses.

MO: selection of trials; extraction of data; interpretation of data analyses; updating review.

D E C L A R A T I O N S O F I N T E R E S T

The authors have produced various training materials in dementia care, including cognitive stimulation therapy manuals, in order to

disseminate research findings to care workers and others. Royalties for the manuals are received by the Dementia Services Development

Centre Wales. AS receives fees for providing training in cognitive stimulation approaches.

S O U R C E S O F S U P P O R T

Internal sources

• Bangor University, UK.

• University College London, UK.

External sources

• NIHR, UK.

EA was supported by the Support at Home - Interventions to Enhance Life in Dementia (SHIELD) project (Application No RP-PG-

0606-1083) which is funded by the NIHR Programme Grants for Applied Research funding scheme.

N O T E S

This review replaces the review of Reality Orientation for dementia (Spector A, Orrell M, Davies S, Woods B. Reality orientation for

dementia. The Cochrane Database of Systematic Reviews 2000, Issue 3. Art. No.: CD001119. DOI: 10.1002/14651858.CD001119).

I N D E X T E R M S

Medical Subject Headings (MeSH)

Cognition [∗physiology]; Dementia [∗therapy]; Memory [physiology]; Orientation [∗physiology]; Psychotherapy [∗methods]; Ran-

domized Controlled Trials as Topic



MeSH check words

Aged; Humans



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