Music Interventions for Dementia and Depression in ELderly care (MIDDEL): International cluster-randomised trial

MIDDEL is a large international research project investigating the effect of music interventions to reduce depressive symptoms among elderly with dementia living in care homes. Dementia and depression are relatively common conditions in older adults, and are associated with substantial individual distress, burden for care providers, and high societal costs. Meanwhile, music interventions represent a highly promising type of non-pharmacological interventions for both dementia and depression in older adults. They are widely used, but have yet to be rigorously tested in large trials. The MIDDEL trial Is the largest trial of music interventions to date, and the first to compare two different approaches group music therapy (GMT), and recreational choir singing (RCS) alone and in combination across countries. A total of 86 care home units were recruited and randomized to four study conditions: GMT, RCS, both interventions, or neither intervention. Participants were care home residents aged 65 years or older with dementia and depressive symptoms. Recruitment was finalized in January 2023, with over a thousand participating residents across the care home units. Twelve of these were in Norway (Bergen and Kinn municipalities). The project period ended on Dec 31st 2023, and findings will be analyzed and submitted for publication in 2024. Outcomes include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, quality of life, medication use, and costs. These were assessed at month 0, 3, 6 and 12. The primary outcome is the change in residents scores on the Montgomery-Åsberg Depression Rating Scale at 6 months. Staff at the care home units could also participate by responding to questions about care team burden. Study sites were located in Australia, Germany, the Netherlands, Norway, Turkey and the United Kingdom. MIDDEL was hosted by GAMUT - The Grieg Academy Music Therapy Centre, NORCE. For more information and updates, please visit the MIDDEL project website: https://www.middel-project.eu or follow us on Facebook https://facebook.com/MIDDELproject

MIDDEL ble utformet for å gi pålitelig og generaliserbar kunnskap om effekt, mekanismer og heterogenitet av effekter av musikkintervensjoner. Til tross for utfordringer knyttet til pandemien og nedstengninger av sykehjem mens studien pågikk, lykkes prosjektet i å oppnå det ønskede antall deltakere for å belyse problemstillingene. Ved prosjektslutt arbeides det med å analysere resultatene, og med en rekke publikasjoner knyttet til disse. Resultatene vil drive endringer i eldreomsorgen, bidra til vår forståelse av sammenhengen mellom musikk og helse, og gi viktig kunnskap rettet mot å forbedre livene til det raskt økende antallet mennesker som lever med demens. Hvis intervensjoner som undersøkes i MIDDEL viser seg å være fordelaktige, må det gjøres vurderinger av skalerbarhet for vellykket implementering. Mens gruppemusikkterapi (GMT) krever spesialiserte musikkterapeuter og små grupper, kan sangstund (RCS) leveres av mindre spesialiserte musikere i større grupper. MIDDEL vil kunne identifisere den beste målgruppen for begge tilnærmingene, og vil også bidra til forbedring og standardisering av intervensjonene. Som et meget tverrfaglig prosjekt som bygger på medisin, samfunnsvitenskap og humaniora, har MIDDEL bidratt til å styrke samarbeidet mellom disse feltene. Det store datamaterialet som er innsamlet i forbindelse med prosjektet stimulerer en mengde tverrfaglige forskningsartikler og mulige nye prosjekter, og vil dermed også benyttes til å undersøke problemstillinger utover prosjektets opprinnelige målsetting.

MIDDEL is a multinational pragmatic cluster-randomised trial aiming to determine the effects of two complex music interventions on older adults living in residential care, suffering from both dementia and depression. With high prevalence and comorbidity in older adults, dementia and depression are associated with individual distress and high and rising societal costs. This trial will study comparative effects of GMT, RCS, their combination, or standard care, in older adults with dementia and depression, also including long-term effects on key outcomes such as depression and quality of life. 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 previous small-scale RCTs and pilot investigations, the trial will have adequate power to determine clinical effects as well as to explain variation in treatment effects in relation to patient characteristics. 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. Representatives of users and municipal care services 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.