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A Feasibility Randomised Control Trial of Individual Cognitive Stimulation Therapy For Dementia Impact On Cognition Quality of Life and Positive
A Feasibility Randomised Control Trial of Individual Cognitive Stimulation Therapy For Dementia Impact On Cognition Quality of Life and Positive
A Feasibility Randomised Control Trial of Individual Cognitive Stimulation Therapy For Dementia Impact On Cognition Quality of Life and Positive
To cite this article: Luke Gibbor, Lycia Forde, Lauren Yates, Stavros Orfanos, Christina
Komodromos, Harriet Page, Kate Harvey & Aimee Spector (2021) A feasibility randomised
control trial of individual cognitive stimulation therapy for dementia: impact on cognition,
quality of life and positive psychology, Aging & Mental Health, 25:6, 999-1007, DOI:
10.1080/13607863.2020.1747048
and consequently be at higher risk of cognitive decline. on cognition, QoL and positive psychology (measured by
One-to-one intervention could provide a sense of social self-rated positive psychology and engagement and inde-
engagement more accessible to those unsuitable to groups, pendence in PWD). This study also aims to establish the
which may lessen the impact of isolation. feasibility of conducting a larger RCT of iCST by considering
A 75-session individual Cognitive Stimulation Therapy feasibility of recruitment, acceptability of randomisation,
(iCST) was developed to be delivered by family caregivers attrition and feasibility of the outcome measures used.
(Yates et al., 2015), based on the original group CST
and MCST programmes (Aguirre et al., 2011; Spector,
Thorgrimsen, Woods, & Orrell, 2006). A randomised control
Method
trial (RCT) indicated no benefits to cognition or QoL (Orrell Ethics statement
et al., 2017), although there were improvements in caregiv-
ing relationship and carer QoL. However, there were several Ethical approval was received from the University College
limitations and feasibility issues. Of note, only 40% of the London Research Ethics Committee (ref no. 12503/001).
sample allocated to iCST completed at least two sessions Participants provided informed consent in accordance with
a week, with a further 22% completing no sessions. Also, the Mental Capacity Act (2005) and they could withdraw
qualitative interviews during development and follow-up from the study at any time. Consent to taking part in iCST
phases highlighted difficulties including time required to activities and assessments was reviewed throughout.
deliver iCST thrice-weekly, difficulties for carers engaging
PWD which related to the level of decline associated with Design
dementia and relationship dynamics when close family
members became a ‘therapist’, which felt discordant with The study was a single blind multi-centre randomised
their familial relationship (Yates et al., 2015; Leung, Yates, controlled pilot study. A sample size of 32 was identified
Orgeta, Hamidi, & Orrell, 2017). Some carers also felt insuffi- as feasible to recruit. GPower (Faul, Erdfelder, Lang, &
ciently skilled to deliver the sessions (Orrell et al., 2017). Buchner, 2007) was used to determine that based on this
In consideration of previous limitations, delivery by pro- number, with alpha set at .05 and power at 0.80, a large
fessionals may enable more consistent iCST delivery and effect size of 0.51 (Cohen’s f) could be detected with an
involve higher motivation for both parties due to the ANCOVA with one covariate.
professional, unlike family members, being less regularly
exposed to the decline associated with dementia. Secondly,
iCST development
the adherence rates and qualitative data suggest the ori-
ginal frequency and number of sessions was not feasible Researchers reviewed the current literature on CST includ-
(Orrell et al., 2017, Leung et al., 2017). Twice-weekly ing the original group CST (Spector et al., 2006), MCST
sessions would allow greater flexibility in the timing and (Aguirre et al., 2011) and iCST (Yates et al., 2014) manuals.
delivery of sessions and past research has consistently sup- Key principles of iCST were retained from the original iCST
ported the benefits of a 14-session group CST programme manual (Yates et al., 2014), with emphasis on providing
delivered twice weekly, suggesting this is a sufficient dose choices for each session and encouraging adjustment of
to detect benefits if they exist. Finally, CST research has his- session content to the individual preferences and abilities of
torically been conducted in care homes, in which residents PWD. The structure of sessions was also retained from the
may be more sensitive to change. A large proportion (39%) original iCST manual, with each session beginning with a
of PWD lives in care homes (Prince et al., 2014), in which “warm-up” consisting of sensitive discussion of orientation
need for social contact, meaningful activity and boredom information, discussion of a newspaper article or recent
are widely unmet needs (Cohen-Mansfield, Dakheel-Ali, events, followed by a themed activity. Each session has a
Marx, Thein, & Regier, 2015). Thus, a further study in this suggested length of 45-minutes, providing the same dose as
setting may be suitable to re-evaluate the potential of the original CST programme in terms of frequency of ses-
iCST. In addition, Stoner, Orrell, Long, Csipke, and Spector sions and weekly time (three 30-minute sessions a week). If
(2017) highlighted the importance of ‘positive psychology’ session length was too long for individuals, allowances were
in understanding wellbeing and positive outcomes in made to terminate a session early.
dementia, which relates to the study of positive emotions Selection of themes for sessions was informed by qualita-
and other factors that contribute to individual’s ability to tive feedback from the field-testing phase of the develop-
‘flourish’ (Gable & Haidt, 2005; Seligman, Steen, Park, & ment of iCST (Yates, Orgeta, Leung, Spector, & Orrell, 2016)
Peterson, 2005). The addition of measures based on posi- which explored which of the sessions were more valued or
tive psychology perspectives could offer an alternative enjoyable. For example, the original CST session on ‘Current
approach focusing on the positive impact of iCST com- Affairs’ was removed as it has been rated less interesting
pared to the historic use of outcomes measuring reduction and enjoyable than other sessions in field-testing of iCST
in negative symptoms. (Yates et al., 2016) and was still incorporated into each
The current study aims to develop and pilot a revised session during the warm-up. The revised iCST programme
iCST programme that minimises the barriers identified in followed a similar order and content to group CST with
the previous iCST trial and subsequent qualitative feedback adjusted guidance to reflect the one-to-one nature of the
(Orrell et al., 2017; Leung et al., 2017). It assesses the feasi- intervention. The developed manual provided sessional
bility of a programme of 14, 45-minute iCST sessions deliv- plans and examples of activities with additional paper
ered by a professional twice weekly over seven weeks and resources and suggested materials for each session.
considers its impact compared to treatment as usual (TAU) Worksheets and suggested materials were developed
AGING & MENTAL HEALTH 1001
Missing data analysis for Equality of Variance was not significant for all comparisons,
For two items on the proxy QoL-AD (items seven and twelve), p > .05, indicating equal variances could be assumed
there was a high percentage of missing responses. These between groups at follow-up. Scores did not differ signifi-
items were therefore excluded from total scores on the QoL- cantly between groups at baseline for any outcome measures
AD. To allow complete analysis and maintain power, multiple (Table 2). There was a significant difference between iCST and
imputation using a MCMC method was used to impute other TAU at follow-up on the ADAS-Cog, with those receiving iCST
missing values. However, participants were excluded from scoring significantly lower (indicating better cognitive func-
analyses for measures in which they had large amounts of tion) than TAU with a mean difference (MD) of 5.04 (95%
missing data across a measure. There were 63.33% of partici- confidence intervals (CI) 8.57 to 1.51) whilst accounting for
pants having at least one missing response, but only 3.57% of baseline scores. There were no significant differences between
values missing from the data set. Eight items (5%) had 10% groups on the SMMSE, or on measures of QoL or positive
missing responses, and four items had between 10% and 17% psychology. Table 3 provides a summary of results for out-
missing responses. No items had more than 17% missing. comes of cognition, QoL and positive psychology.
Discussion
Analyses of outcome measures
Analyses were conducted on the 29 participants who com- The current study aimed to develop and evaluate a 14-session
pleted both baseline and follow-up assessments. Levene’s Test programme of iCST for PWD delivered by professionals in a
1004 L. GIBBOR ET AL.
Table 3. ANCOVA comparing group differences at follow-up adjusting for baseline scores.
Scores at Follow-Up Mean Difference
iCST Mean TAU Mean Mean ANCOVA (between-group
Measure (SD) (SD) (SD) 95% CI difference)
SMMSE 20.44 22.77 0.49 3.39 to 2.40 F (1,26) ¼ 0.12,
(4.05) (4.62) (1.41) p ¼ .73
ADAS-Cog 19.44 23.15 5.04 8.57 to 1.51 F (1,26) ¼ 8.61,
(3.50) (11.82) (1.72) p ¼ .0070
partial g2 ¼ 0.25
QoL-AD 35.32 37.95 0.06 3.97 to 3.85 F (1,26) ¼ 0.001,
(Self-rated) (5.91) (6.02) (1.90) p ¼ .98
PPOM 45.77 44.50 6.62 2.02 to 15.26 F (1,26) ¼ 2.48,
(8.93) (17.91) (4.20) p ¼ 0.13
EID-Q 71.75 78.06 4.47 12.98 to 4.04 F (1,25) ¼ 1.17,
(12.11) (17.79) (4.13) p ¼ 0.29
QoL-AD 29.84 28.02 1.67 3.14 to 6.48 F (1,25) ¼ 0.51,
(Carer) (5.73) (6.60) (2.34) p ¼ .48
Denotes a significant difference at alpha ¼ .01.
iCST ¼ individual cognitive stimulation therapy; TAU ¼ treatment as usual; SD ¼ standard deviation; ADAS-Cog ¼ Alzheimer’s Disease Assessment Scale-
Cognitive Sub-scale; SMMSE ¼ Standardised Mini Mental State Examination; QoL-AD ¼ Quality of Life in Alzheimer’s Disease, PPOM ¼ Positive Psychology
Outcome Measure; EID-Q ¼ Engagement and Independence in Dementia Questionnaire, Mean Difference ¼ mean difference adjusting for baseline scores.
feasibility randomised controlled trial. The intervention was study within approximately six months. Although 23% of
feasible with good attendance (81% of individuals receiving a people approached did not meet inclusion criteria, this
full dose of 14 sessions of iCST and 97% session attendance) may be a result of care home manager eagerness for indi-
and minimal attrition, with only individuals in the TAU group viduals to receive intervention, for example referring sev-
withdrawing from the study for reasons unrelated to study eral people who were without a diagnosis of dementia.
participation, and no adverse events from taking part. In add- Improved scores of five points on the ADAS-Cog for the
ition, there were minimal difficulties recruiting to the study, iCST group at follow-up (compared to TAU) suggests that
and randomisation appeared acceptable with little difference iCST may also provide benefits to cognition, in contrast to
in attrition rates between iCST and TAU. Findings also suggest previous findings (Orrell et al., 2017). Of note, a change of
it may provide benefits to cognition, however there was no four points or more on the ADAS-Cog has historically been
significant impact on measures of QoL or positive psychology. considered clinically important in drug trials (Rockwood,
Overall, these findings suggest that a larger RCT of iCST would Fay, Gorman, Carver, & Graham, 2007). In addition, the
be both feasible and warranted, and indicated several recom- effect size of the intervention on ADAS-Cog scores was
mendations for future research. large (Cohen, 1992), but it is important to note this may be
exaggerated in small sample sizes. Conversely, there was
no significant differences between groups on the SMMSE.
Interpretation of results
This is comparable to Hall, Orrell, Stott, and Spector (2013),
One of the main limitations in the previous iCST trial was who found benefits to memory and orientation following
poor treatment adherence (Orrell et al., 2017). There are group CST, but no improvement on the MMSE. However, it
several key differences in the current study that may is possible that the MMSE, which has a relatively small
underlie the improved adherence found. Firstly, the revised range, is simply less sensitive to smaller changes in cogni-
manual was adapted in line with both qualitative findings tion. This is reflected in past findings, where change in
from iCST’s development phase (Yates et al., 2015) and the points on the MMSE was half that found in the ADAS-Cog
original session content of CST (Spector et al., 2006). As (Spector, Orrell, & Woods, 2010).
such, each session may have been more broadly enjoyed There may be several explanations for the difference in
as it incorporated sessions and activities shown to be pre- overall findings compared to past iCST trials. Firstly, the
ferred in previous research. Secondly, the use of professio- current study was more closely related to group CST, as
nals addressed difficulties experienced by family carers the weekly dose and most content were kept the same
delivering iCST. For example, professionals were more likely (Spector et al., 2006) and the sample was similarly recruited
to, due to the nature of their role, have more training and from care homes. Secondly, as mentioned above, professio-
skills related to delivery of psychosocial interventions. nals may be better equipped to deliver sessions in terms of
Professionals were also less likely to feel burnt out, as the training and motivation. In combination with improved
intervention is more likely seen as part of their role and adherence, these differences may have contributed to the
could be less emotionally invested in the PWD’s perform- contrast in cognitive outcomes.
ance on tasks. Finally, carers delivering iCST had found it There were no significant differences between groups
difficult fitting sessions into a busy schedule (Orrell et al., on measures of QoL or positive psychology, though it is
2017; Yates et al., 2016) which may be addressed by the possible the limited sample size did not have sufficient
reduction to 14 sessions. power to detect small effects. Further, the lack of clarity
Although assessment of fidelity was beyond the resour- experienced by some participants in the questionnaires
ces of the current study, the intervention was manualised could have limited understanding for those with lower
and there were no difficulties reported by researchers in functioning, which may have impacted upon responses. In
delivering it as planned. It is also important to note that addition, previous findings showing that CST benefits QoL
most care homes and participants were recruited for the may be explained by the general benefits of engagement
AGING & MENTAL HEALTH 1005
Funding Leung, P., Yates, L., Orgeta, V., Hamidi, F., & Orrell, M. (2017). The expe-
riences of people with dementia and their carers participating in
This project was supported by University College London as part of a individual cognitive stimulation therapy. International Journal of
Doctorate in Clinical Psychology thesis. Geriatric Psychiatry, 32(12), e34–e42. doi:10.1002/gps.4648
Lewin, S., Glenton, C., & Oxman, A. D. (2009). Use of qualitative meth-
ods alongside randomised controlled trials of complex healthcare
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