Introduction In 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 analysis This 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 dissemination Ethical 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 numbers NCT03496675; Pre-results, ACTRN12618000156280.
- depression & mood disorders
- care homes
- music therapy
- music interventions
- old age psychiatry
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Contributors CG took the initiative for the study; CG, JE, JA, BS, HMOR, SZ and RR developed the concept and design; FAB, JT, IC, YCL, GK, DM, TW, EC, AR, MR, AV, HOM, MO, JS, and MG helped to revise the concept and design. CG drafted the manuscript; JE, JA, RR, and MG helped drafting the manuscript. BS, JDW, FAB, JT, IC, YCL, SLJ, HMOR, GK, DM, TW, EC, AR, MR, AV, SZ, HOM, MO, JS, CK revised the manuscript for important intellectual content. CG, FAB, JT, IC, HMOR, and SZ obtained funding. BS, FAB, JT, IC, YCL, SLJ, HMOR, GK, DM, TW, EC, AR, MR, AV, SZ, HOM, and MG were involved in setting up the study conduct in each site. JDW, FAB, JT, IC, YCL, CK, and MG provided administrative, technical, or material support. All authors approved the final version of the manuscript.
Funding This work was supported by an Australian National Health and Medical Research Council Grant (grant number APP1137853) and by intramural support from Uni Research AS and University Medical Center Groningen.
Competing interests None declared.
Ethics approval Ethical approval has been obtained from the Medicine and Dentistry Human Ethics Sub-Committee at the University of Melbourne, Australia (approval date: January 12, 2018).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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