Department of Psychiatry and Behavioural Sciences, University College London
Dementia Services Development Centre, University of Wales, Bangor
Department of Clinical Psychology, Petersfield Centre, Harold Hill, London
Department of Psychology, Derwent Unit, Princess Alexandra Hospital, Harlow, Essex
Department of Psychiatry and Behavioural Sciences, University College London, UK
Correspondence: Dr Martin Orrell, Department of Psychiatry and Behavioural Sciences, UCL, Wolfson Building, 48 Riding House Street, London W1N 8AA, UK. Tel: 020 7679 9452; fax: 020 7679 9426; e-mail: m.orrell{at}ucl.ac.uk
Declaration of interest None. Funding detailed in Acknowledgements.
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ABSTRACT |
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Aims To testthe hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life.
Method A single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variabilityin baseline measures.
Results One hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimers Disease Assessment Scale Cognition (ADASCog) (P=0.014) and Quality of Life Alzheimers Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADASCog the number needed to treat was 6 for the intervention group.
Conclusion The results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia.
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INTRODUCTION |
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METHOD |
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Inclusion criteria
People were considered suitable for full assessment and participation if
they:
Design and process of randomisation
In residential homes and day centres with at least eight suitable
participants, full assessments were conducted in the week prior to, and the
week following, the intervention by a researcher masked to group membership.
Groups were established in 23 centres (18 residential homes and 5 day
centres). Of 292 people screened, 201 participants (115 treatment, 86 control)
entered the study (Fig. 1).
There were more people in the intervention group because frequently centres
had only eight or nine suitable participants, and five of these had to be
randomised to the intervention group. Control group participants from each
centre continued with usual activities while the group therapy was in
progress. For most residential homes usual activities consisted
of doing nothing. For the other centres, usual activities included games such
as bingo, music and singing, arts and crafts, and activity groups. Within each
centre, one researcher (the therapist) ran the group and the other (the
assessor) conducted initial and follow-up assessments, ensuring masking.
Participants were randomly allocated into treatment and control groups. The
assessor ordered the names of the selected participants for each centre
alphabetically and allocated numbers in sequence according to the total number
to be randomised (810). The therapist independently placed identical
numbered discs into a sealed container and the first five numbers to be drawn
out formed the treatment group. The appropriate multi-centre and local
research ethics committees granted ethical approval. Informed consent was
obtained from participants. After an explanation of the study, those who
agreed to participate were asked to sign the consent form in the presence of a
witness (usually a member of staff). People whom the staff felt were too
impaired to understand the nature of the study were excluded, and it usually
followed that they were too impaired to participate in the groups. Using the
results from our pilot study, we estimated that a sample size of 64 in each
group was required to achieve 80% power to detect a difference in means of 2
points (MMSE). This assumed that the common standard deviation was 4.0, using
a two-group t-test with a 0.05 (two-sided) significance level.
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The programme
The 14-session programme ran twice a week for 45 min per session over 7
weeks. It was designed using the theoretical concepts of reality orientation
and cognitive stimulation. It largely focused on a trial of cognitive
stimulation (Breuil et al,
1994), which was identified through the systematic reviews as
having the most significant results. Topics included using money, word games,
the present day and famous faces. The programme included a reality
orientation board, displaying both personal and orientation
information, including the group name (chosen by participants). The board was
to provide a focus, reminding people of the name and nature of the group, and
creating continuity. Each session began with a warm-up activity, typically a
softball game. This was a gentle, non-cognitive exercise, aiming to provide
continuity and orientation by beginning all sessions in the same way. Sessions
focusing on themes (such as childhood and food) allowed the natural process of
reminiscence but had an additional focus on the current day. Multisensory
stimulation was introduced when possible. Sessions encouraged the use of
information processing rather than factual knowledge. For example, in the
faces activity, people were asked, Who looks the
youngest? What do these people have in common?, with
factual information as an optional extra. A range of activities for each
session enabled the facilitator to adapt the level of difficulty of the
activities to take into account the groups cognitive capabilities,
interests and gender mix. The 14-session programme has been previously
described in depth (Spector et
al, 2001).
Assessment measures
Cognition
The primary outcome variable was the MMSE
(Folstein et al,
1975). This is a brief, widely used test of cognitive function,
with good reliability and validity. The secondary outcome variable was the
Alzheimers Disease Assessment Scale Cognition (ADASCog;
Rosen et al, 1984);
this is a more sensitive scale measuring cognitive function and including more
items that assess short-term memory. It is frequently used in drug trials as
the principal cognitive measure, allowing the effects of cognitive stimulation
therapy to be compared with antidementia drugs.
Quality of life
The Quality of Life Alzheimers Disease scale (QoLAD;
Logsdon et al, 1999)
was used as a secondary outcome variable; it has 13 items covering the domains
of physical health, energy, mood, living situation, memory, family, marriage,
friends, chores, fun, money, self, and life as a whole. This brief,
self-report questionnaire has good internal consistency, validity and
reliability (Thorgrimsen et al,
2003).
Communication
The Holden Communication Scale (Holden
& Woods, 1995), which is completed by staff, covers a range of
social behaviour and communication variables, including conversation,
awareness, pleasure, humour and responsiveness.
Behaviour
The Clifton Assessment Procedures for the Elderly Behaviour Rating
Scale (CAPEBRS; Pattie &
Gilleard, 1979) covers general behaviour, personal care and
behaviour towards others. It has good reliability and validity, and was
included to assess the overall level of functional impairment and
dependency.
Global functioning
The Clinical Dementia Rating scale (CDR;
Hughes et al, 1982),
completed by the researcher, provided a global rating of dementia severity at
baseline.
Depression
The Cornell Scale for Depression in Dementia
(Alexopoulos et al,
1988) rates depression in five broad categories (mood-related
signs, behavioural disturbance, physical signs, biological functions and
ideational disturbance) using information from interviews with staff and
participants. Good reliability and validity have been demonstrated.
Anxiety
Anxiety was assessed using the scale Rating Anxiety in Dementia (RAID;
Shankar et al, 1999);
this rates anxiety in four main categories (worry, apprehension and vigilance,
motor tension, and automatic hypersensitivity) using interviews with staff and
participants. It has good validity and reliability.
Analysis
Data were entered into the Statistical Package for the Social Sciences,
version 10 for Windows (SPSS,
2001). An intention-to-treat analysis was conducted and analysis
of covariance (ANCOVA) was chosen as the method of analysis because it
controls for variability in pre-test scores (the covariate;
Vickers & Altman, 2001).
Age, gender and baseline score on the scale being examined were entered as
covariates, together with centre entered as a random factor,
because treatment was defined as participation in the group programme within
the confines of one of the 23 centres.
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RESULTS |
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Difference between groups at follow-up
In Table 2, significance
levels set at 5% are presented from the ANCOVA comparing groups (treatment and
control) in all instances. Significant results for covariates (centre and/or
gender) are included when they occurred. At follow-up, the treatment group had
significantly higher scores on MMSE and ADASCog and rated their quality
of life (QoLAD) more positively than the control group did, and the
confidence intervals for the differences between groups were above zero for
all three measures. There was a trend towards an improvement in communication
in the treatment group (P=0.09) but no difference between the groups
in terms of functional ability (CAPEBRS), anxiety or depression. Centre
emerged as a significant covariate in relation to ADASCog, Holden
Communication Scale, Cornell and RAID scales, and CAPEBRS score. A
number of gender differences emerged. Quality of life for women in the
treatment group improved more than that for the men, whereas the quality of
life for men in the control group deteriorated significantly more than it did
for the women. Dependency levels (CAPEBRS) and communication (Holden)
also deteriorated for men in the treatment group (though less than for the men
in the control group). In contrast, women in the treatment group improved on
both measures whereas women in the control group deteriorated (though less
than the men in the control group).
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Numbers needed to treat
The number needed to treat (NNT) is a calculation of the number of people
who needed to be treated in a particular intervention in order to achieve one
favourable outcome. It is calculated as the reciprocal of the absolute
risk reduction: the difference in the proportion experiencing a
specified adverse outcome between the control and treatment groups. Using the
formulae and framework provided in a previous study
(Livingston & Katona,
2000) including acetylcholinesterase inhibitors, two NNT analyses
using the ADASCog scores were performed in this study
(Table 3):
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DISCUSSION |
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Contrary to the Cochrane review (Spector et al, 1998) we found no change in behaviour in this study (and the former review found only one individual trial that demonstrated a significant difference in behaviour (Baines et al, 1987)). Changes in cognition might be unlikely to have any impact on areas of functional dependence described in the CAPEBRS, such as feeding and dressing (Woods, 1996). Other authors (Zanetti et al, 1995) have suggested that behavioural outcome measures are often not sensitive enough to detect the functional impact of cognitive stimulation programmes. There were positive trends in communication, which had not been shown empirically in any of the earlier reality orientation trials. Communication is a factor that is likely to deteriorate in individuals moving into residential care, yet the small-group context was probably novel for many of the participants, perhaps exercising long unused communication skills. It is not known why women reacted more favourably to the programme. For men, being in the minority in most groups could have created discomfort and a reluctance to communicate.
Variation between centres
There was a significant variation between centres from baseline to
follow-up in measures of cognition (ADASCog), behaviour, mood and
communication. Some centres appeared more institutionalised, and in these
there were poor staffpatient relationships and functioning was not
optimised. Thus, it might have been the case that the effects of groups were
not strong enough to combat the effects of a negative environment. Moreover,
in some centres with a better quality of social environment, perhaps including
a local programme of activities, residents might have been functioning near
their optimum, leaving little scope for improvement. Groups including people
at different stages of dementia were sometimes difficult to run. People with
milder dementia could become irritated by people with more severe cognitive
impairment, and observing their confusion might have been off-putting and
hence detrimental to the group process. Pitching the sessions at an
appropriate level was clearly important. It is possible that the social
interaction provided by the groups could have been of benefit, but our
Cochrane review (Spector et al,
1998) found that in RCTs social groups appeared to be of no
benefit to cognition.
Limitations
Rigorous inclusion criteria were necessary to ensure a reasonably
homogeneous participant group, and were aimed at recruiting people who were
able to participate and less likely to leave the study. This meant many
centres were excluded because of insufficient numbers. Cluster randomisation
might have been useful in allowing centres with five to seven suitable
candidates to be included, but would have had the disadvantage that large
numbers of clusters would be needed to ensure statistical power and external
validity (Bowling, 1997). More
importantly, the significant difference between centres on many scales in this
study shows that it would have been difficult to ensure the comparability of
clusters. Outside the context of a research trial, groups would probably be
selected through clinical judgement, considering how people would mix; and
people with poorer vision or hearing, or with greater communication
difficulties, might be included to make up numbers.
There were a number of other limitations. In the randomisation procedure ideally the generation of the allocation sequence, enrolment into the trial and allocation to group should be separate and performed by different, independent staff. Differences in control conditions between centres meant that the control group was not homogeneous; however, usual activities generally meant doing nothing. Last, in contrast to the results on the primary and secondary outcome measures which were rated directly with the participants, none of the scales rated by staff (e.g. mood, communication, behaviour) showed significant improvements for the cognitive stimulation therapy group. Staff perceptions about the therapy groups might have introduced a bias into the ratings of the scales. We took precautions to avoid this by ensuring that the local member of staff who acted as co-therapist was not involved in completion of the rating scales. However, it is likely that other staff could have been aware of which people were in the groups and this might have influenced their ratings.
Comparison with acetylcholinesterase inhibitors
Number-needed-to-treat analyses were previously performed for three
acetylcholinesterase inhibitors: tacrine, rivastigmine and donepezil
(Livingston & Katona,
2000). Analyses were performed identically in this study,
considering two levels of change as improvement, so that a direct comparison
could be made (Table 3).
Calculations were also included for galantamine, using the results from
another trial (Wilcock et al,
2000). These comparisons show that for small improvements or no
deterioration, the programme was not quite as effective as rivastigmine,
donepezil and galantamine. For greater improvements (4 or more points),
cognitive stimulation therapy did as well as galantamine or tacrine and
substantially better than rivastigmine or the lower dosage of donepezil (5
mg). Only the higher dosage of donepezil (10 mg) had a smaller NNT. These
results are particularly interesting considering that the drug programmes
lasted for 24 weeks, 26 weeks or 30 weeks compared with only 7 weeks of
cognitive stimulation therapy. However, since these drug studies applied only
to Alzheimers disease, and since drug therapy and psychological therapy
are different forms of treatment, some caution is required when interpreting
these comparisons.
Mechanisms for change
There are a number of possible mechanisms of change. The learning
environment during sessions was designed to be optimal for people with
dementia, for example by focusing on implicit memory and integrating
reminiscence and multi-sensory stimulation throughout the programme.
Stimulation in the group could improve cognition and might make participants
feel more able to communicate. The groups could work against the excess
disability due to the malignant social psychology of a negative
social environment (Kitwood,
1997) by improving self-esteem through social stimulation and
encouragement. Finally, groups positively reinforced questioning, thinking and
interacting with other people, objects and the environment. This effect might
have extended beyond the groups, with people communicating more effectively
and responding to the environment and to others.
Recent research has highlighted strategies that can involve memory training and cognitive stimulation programmes. Providing participants with didactic training (forming mental images of words) and problem solving (practical steps to manage daily problems, such as using notebooks and calendars) has been shown to result in small but short-lived changes in memory performance (Zarit et al, 1982). The use of external memory aids, such as diaries, calendars, large clocks and clear signposting, is becoming increasingly common for people with dementia. Research is also identifying ways of creating an optimal learning environment: for example, errorless learning involves encouraging people, when learning new information, only to respond when they are sure that they are correct, thus avoiding interference effects; and spaced retrieval involves learning and retaining information by recalling information over increasingly long periods (Clare & Woods, 2001).
Implications
This study found improvements in both the primary (MMSE) and secondary
(ADASCog and QoLAD) outcome measures for people in the cognitive
stimulation therapy group. Although there is a body of research on the various
psychological interventions for dementia, much of it lacks methodological
rigour and might not be considered evidence-based. The previous
RCTs were small, with the largest having 56 participants
(Breuil et al, 1994), and could be criticised for weaknesses such as lack of standardisation of
groups, selection and detection biases, and absence of intention-to-treat
analyses. Our study is the only major evidence-based trial examining the
effectiveness of cognitive stimulation therapy for dementia. Some guidelines
counsel against the use of cognitive stimulation programmes because of the
possibility of adverse reactions such as frustration
(American Psychiatric Association,
1997). This study has shown that cognitive improvements are
associated with benefits to quality of life rather than deterioration. Indeed,
this is the first study to show improvements in quality of life of people with
dementia participating in such a programme. The findings suggest that reality
orientation groups, which are widely used both throughout the UK and
internationally, are likely to be beneficial for many people with dementia and
should be regarded more positively by staff, carers and service providers.
Future research needs to identify the most effective ways of teaching care
staff to implement this programme, the possible benefits of a longer-term
cognitive stimulation therapy programme, and the potential effects of
combining cognitive stimulation therapy with drug therapy.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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Received for publication January 13, 2003. Revision received May 13, 2003. Accepted for publication May 13, 2003.
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