ABSTRACT

The body of evidence demonstrating the short- and long-term benefits of group Cognitive Stimulation Therapy (CST) for people with dementia is substantial. The individual CST (iCST) programme and materials were refined according to feedback from key stakeholders and experts in the field. A modified Delphi process consisting two rounds was conducted to achieve consensus on themes that participants had been unable to reach agreement on the focus groups, interviews, and field-testing. The web-based randomisation service was managed by a Clinical Trials Unit in the UK. A dynamic, adaptive randomisation algorithm was selected to ensure balance overall, within stratification variable and stratum. Dyads randomised into the treatment as usual (TAU) arm did not receive any additional intervention for the duration of their participation. The services and treatments accessed by control group dyads varied between and within centres. The social setting and additional stimulation from participating in a group context may account for the difference in outcomes between iCST and group CST.