Psychological treatments for dementia such as Reality Orientation (RO) and Reminiscence have been in use for nearly half a century, and are widely used in the UK and internationally, but often have not been standardised, adequately evaluated or systematically implemented. A number of systematic reviews of psychosocial interventions are now available [
1‐
3], as well as a number of Cochrane reviews of specific approaches [e.g. [
4,
5]]. The Spector review of RO [
5] was used to develop a seven-week evidence-based Cognitive Stimulation Therapy (CST) programme for people with dementia [
6]. A total of 201 people with dementia were recruited for this single-blind, multi-centre RCT from 23 day centres and residential homes in greater London. The CST group improved significantly on the main outcome measures (cognition and quality of life). CST compared favourably with cholinesterase inhibitors for Alzheimer's disease in terms of numbers needed to treat (NNT) [
6] and the economic analysis showed that CST was likely to be cost-effective [
7]. The recent UK guidelines on dementia [
8] recommend that all people with mild/moderate dementia should be 'given the opportunity to participate in a structured group cognitive stimulation programme'.
The evidence for the long-term effects of CST is less conclusive. Feedback from the CST training and previous studies [
6] suggested that service users preferred a longer-term programme after the seven-week CST intervention. A number of studies have looked at the longer-term effects of cognitive stimulation and related interventions. A recent pilot study of longer-term CST (maintenance CST) [
9], offering 16 weekly sessions of maintenance, following the initial CST programme, found a significant improvement in cognitive function (MMSE) for those receiving ongoing Maintenance CST. This lasted nearly 6 months in comparison to a group of CST only and controls (p = 0.012). The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of MCST for dementia. A number of other studies have looked at the longer-term effects of cognitive stimulation and related interventions in combination with cholinesterase inhibitors. Two recent RCTs found that over 6 months, cognitive stimulation and cholinesterase inhibitors in combination, were more effective than cholinesterase inhibitors alone [
10,
11]. There is a distinct overlap between what is described as Reality Orientation (RO) and Cognitive Stimulation. Both programmes often describe similar features, whilst more emphasis is placed on re-learning orientation information in RO, Cognitive Stimulation focuses on implicit information processing. Studies have suggested that with a RO intervention, the cognitive benefits gained were lost after 10 weeks [
12] and one month [
13] after stopping the programme. However, Wallis et al. [
13] found that behavioural functioning continued to improve 10 weeks after the RO programme terminated. Other studies have suggested that longer programmes of RO may have longer-term effects [
14,
15]. Zanetti et al. [
14], found, in a RCT, that the effect of RO on cognitive performance appeared to counteract the decline, observed in the control group, of 2.58 points on the MMSE. Similarly Metitieri et al. [
15] found that people receiving long-term treatment declined in cognitive function significantly later, and remained at home longer than those receiving a shorter programme of RO. Both studies concluded that providing a longer term RO intervention was effective in slowing, at least temporarily, the dementia process. A novel aspect of the Zanetti et al study [
14] was that they described an expected yearly decrease in Mini-Mental-State-Examination score [
16] of 1.8-4.2 points in people with dementia. Therefore, it might be that pre-post comparisons in the studies which had used longer interventions (20 and 21 weeks) would have shown weaker results [
17,
18] as a result of the expected yearly decrease.
It is unclear how far maintenance programmes of CST might continue to benefit the participants. The studies included in the recent CST Cochrane review [
19] ranged from using programmes of four weeks [
20] to one year [
21]. However, no relationship between the duration of the intervention and the outcome was shown. The trials with the strongest results and higher weight in the metanalyses [
6,
11] had 7 to 25 weeks of intervention respectively. Stronger evidence of their effectiveness is needed to support the long-term implementation of CST. It is also necessary to examine whether the combination of Maintenance CST with cholinesterase inhibitors for Alzheimer's disease is cost-effective and brings extra long-term benefits to cognition and quality of life of people with dementia. This paper describes the study protocol for a pragmatic RCT of CST versus CST followed by a 24 week maintenance CST programme undertaken with people experiencing mild to moderate dementia. This research programme aims to provide essential evidence to clarify the role of long-term CST interventions alone and in combination with cholinesterase inhibitors and the analyses of its cost-effectiveness.