Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial

Abstract

IntroductionIn older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups.Methods and analysisThis large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status.Ethics and disseminationEthical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals.Trial registration numbersNCT03496675; Pre-results, ACTRN12618000156280.

Music Therapy in the Treatment of Dementia: A Systematic Review and Meta-Analysis

“…This meta-analysis had several limitations. First, there are many clinical trials in development like NCT03496675 and NCT03271190 (Clinicaltrials.gov), whose completion is estimated to be in 2024 and 2022, respectively, which could not be included in this analysis (56,57). Secondly, there are several important limitations in the design of the trials included.…”

Resource assessment in trials undertaken in residential care homes: Experiences from the Australian MIDDEL cluster randomised controlled trial research team

“…The MIDDEL randomised controlled trial [ 6 ] was designed to test the effectiveness of group music therapy and recreational choir singing on the symptoms of depression and dementia of 1000 people living in RACFs across several countries. In 2017, the Australian MIDDEL team were the first to secure funding and commenced data collection in May 2018.…”

Developing consensus description of group music therapy characteristics for persons with dementia

“…In the first qualitative and unstructured round, a core group of seven experts from four countries (the authors) drafted a set of statements based on literature, professional expertise and personal experiences. The core group consisted of a subgroup of authors who developed the study protocol for the "Music Interventions for Dementia and Depression in Elderly Care (MIDDEL) trial" (Gold et al, 2019) combining expertise in music therapy, medicine, epidemiology and research methodology. The group consisted of members from Austria, Denmark, Germany, Netherlands and Norway.…”

“…Among the many music interventions in dementia that exist, this study focuses on group music therapy (GMT), which is relatively well-studied. In the MIDDEL trial (Gold et al, 2019) which provides the context for this study, GMT is provided by specialized music therapists in small groups and uses various activities ranging "from singing through instrumental music making to music listening" (Gold et al, 2019, p. 2). However, no common best practice guideline or consensus description exists for providing GMT.…”