Abstract
BackgroundPsychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recognition that psychosocial interventions may have similar levels of effectiveness to medication, and both can be used in combination. Cognitive Stimulation Therapy (CST) is a 7-week cognitive-based approach for dementia that has been shown to be beneficial for cognition and quality of life and is cost-effective, but there is less conclusive evidence for the effects of CST over an extended period.Methods/DesignThis multi-centre, pragmatic randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of Maintenance CST groups for dementia compares a intervention group who receive CST for 7 weeks followed by the Maintenance CST programme once a week for 24 weeks with the control group who receive CST for 7 weeks, followed by treatment as usual for 24 weeks.The primary outcome measures are quality of life of people with dementia assessed by the QoL-AD and cognition assessed by the ADAS-Cog. Secondary outcomes include the person with dementia's mood, behaviour, activities of daily living, ability to communicate and costs; as well as caregiver health-related quality of life. Using a 5% significance level, comparison of 230 participants will yield 80% power to detect a standardised difference of 0.39 on the ADAS-Cog between the groups. The trial includes a cost-effectiveness analysis from a public sector perspective.DiscussionA pilot study of longer-term Maintenance CST, offering 16 weekly sessions of maintenance following the initial CST programme, previously found a significant improvement in cognitive function (MMSE) for those on the intervention group. The study identified the need for a large-scale, multi-centre RCT to define the potential longer-term benefits of continuing the therapy. This study aims to provide definitive evidence of the potential efficacy of maintenance CST and establish how far the long-term benefits can be compared with antidementia drugs such as cholinesterase inhibitors.Trial RegistrationISRCTN26286067
Highlights
Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented
This study aims to provide definitive evidence of the potential efficacy of maintenance Cognitive Stimulation Therapy (CST) and establish how far the long-term benefits can be compared with antidementia drugs such as cholinesterase inhibitors
This paper describes the study protocol for a pragmatic randomised controlled trial (RCT) of CST versus CST followed by a 24 week maintenance CST programme undertaken with people experiencing mild to moderate dementia
Summary
Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. 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). 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. 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
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