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Project Topic
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MIDDEL is a multinational pragmatic cluster-randomised trial to determine the effects of two complex music interventions on older adults living in residential care with dementia and depression. As highly prevalent and comorbid conditions in older adults, dementia and depression are associated with individual distress and high and rising societal costs. This trial will provide generalisable results concerning the comparative effects of group music therapy (GMT), recreational choir singing (RCS), their combination, or standard care, in older adults with dementia and depression, including long-term effects on key outcomes (depression, behavioural problems, quality of life, costs). The trial will also enable modelling of trajectories of change and will thereby contribute to an improved understanding of the mechanisms of music interventions. Building on promising results from previous small-scale randomised controlled trials and pilot investigations, this trial will have adequate power to determine clinical effects as well as to explain variation in treatment effects in relation to patient characteristics, thereby contributing to the development of precision medicine in line with the JPND call. Music-based interventions are relevant for both genders and can be tailored to people with different cultural backgrounds. By improving existing interventions and providing evidence-based guidance on their application or discontinuation, this trial is anticipated to benefit the rapidly rising number of people living with dementia, their caregivers, and health systems across countries. A comprehensive set of patient- and service-relevant core outcomes, as well as biomarkers, will be measured. The large sample will ensure sufficient power for stratification of subgroups and to establish the influence of biomarkers on the overall effect of the interventions. The project features interdisciplinary collaboration between specialists in old age medicine and psychology, music therapy, applied health research, trial methodology, and biostatistics. A cost analysis is included to pave the way for a future cost-effectiveness evaluation. Representatives of users (patients, relatives) and municipal care services (care homes) have confirmed the relevance of the questions, interventions, and outcomes and will continue to be involved in all aspects from planning and conducting the trial in participating countries to disseminating and implementing its findings. Findings will therefore be directly applicable to clinical practice and will improve the lives of people living with dementia, their caregivers, and practitioners working with them. The consortium’s high expertise and history of collaboration will ensure the quality and success of the project.
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