Background: Adopting a systematic approach to the development of an intervention, supported by robust theoretical, empirical, and clinical rationales represents best practice. The Medical Research Council (MRC) provides a framework for a systematic step-wise approach to the evaluation of complex interventions. This study describes the development phase of the individual cognitive stimulation therapy (iCST) for dementia trial, within this framework.
Methods: In the preclinical phase, a recent Cochrane Review of cognitive stimulation for dementia and the current literature on individual cognitive stimulation interventions were examined to establish an evidence base. In addition, people with dementia, carers, and care staff were consulted regarding the acceptability of iCST, and a panel was put together to advise the team on the adaptation of group cognitive stimulation therapy (CST). Phase I (modeling) involved consultations with service users and experts in a series of focus groups, interviews, an online survey, and a consensus conference. Finally, Phase II field testing of the intervention was carried out.
Results: Two drafts of the materials were produced before a final version ready for use in the main randomized controlled trial (RCT). Key changes between the drafts included: editorial amendments to improve the clarity of instructions, emphasize the person centeredness of the approach, and reduce the overall length of the introduction section; the simplification of academic terminology and activities deemed "too difficult"; adjustments made to the monitoring-progress forms and session rating scale to enhance user-friendliness; the addition of a "Getting started" section; amendments made to the content of the toolkit; and clearer distinction made between the level of difficulty of activities.
Conclusion: The rigorous development of the intervention was beneficial as the feasibility of the intervention was explored both in theory and practice, and consulting with service users ensured that materials were appropriately tailored to their needs. A Phase III RCT is currently being conducted to determine the effectiveness of iCST.
Keywords: Delphi consensus; MRC framework; cognitive stimulation; intervention development; intervention evaluation.