Methodologies and methods for the development, evaluation, and implementation of psychosocial interventions for dementia: Protocol for a scoping review

Introduction:
Research on psychosocial interventions for dementia demonstrates increased rigor and robustness. However, if we are to influence practice, beyond results from randomized controlled trials, a variety of types and sources of evidence is needed. The Medical Research Council (MRC) framework offers a valuable guide for developing, evaluating and implementing complex interventions, to facilitate integration of research into practice. There is limited knowledge of how researchers design, evaluate and implement psychosocial intervention studies in dementia, using the MRC framework. This scoping review aims to: i) identify the methodological and methods trends, use, and gaps in the development, evaluation and implementation of psychosocial interventions for dementia, and ii) determine if and how the MRC six core elements of the Medical Research Council (MRC) framework (Skivington et al., 2021) were considered and applied in studies.

Methods and analysis:
Six databases (Ovid Medline, Embase, PsycINFO, CINAHL, Web of Science, Cochrane Library) will be searched for studies published from 2015 (when MRC process guidance was published) to 2025. Identified deduplicated citations will be imported into Covidence software, where up to 40% of title/abstracts will be double screened by independent reviewers. ASReview will be used to rank articles by relevance, with a stopping criterion of 250 consecutive irrelevant articles. Full-texts will be reviewed by a single reviewer and those excluded will be checked by a second reviewer. Data extraction will include: study aim/objective (i.e., to develop/adapt; test feasibility/pilot; evaluate; implement);, methodology and methods applied;, rationale for selection, and benefits of/ challenges with the methodological approach. Information will be also extracted on whether and which of the MRC six core elements were considered (yes/no), and if so, how they were addressed (i.e., qualitative details). A narrative synthesis, alongside graphical representations (e.g., table, bar charts, histograms), will be used to synthesize findings on methodologies and methods mapped onto the MRC framework.

Ethics and dissemination:
As secondary analysis, this scoping review does not require ethics approval. The results will be disseminated through peer-reviewed publication(s), seminars, webinars and conference participations. The findings of this review will feed into a Delphi consensus study on the appropriate methodological approaches to (i) develop, evaluate, and implement psychosocial interventions in relation to the MRC core elements and (ii) clarify and advance application of the MRC framework, leading to more efficient, practical, and impactful research and practice.