Abstract
Background: We report UK findings from Music Interventions for Depression and Dementia in Elderly care (MIDDEL), a cross-national, clustered, randomised trial undertaken in 2018-2023 to evaluate the effectiveness of music interventions for depression symptoms in care home residents living with dementia (NCT03496675, clinicaltrials.gov (accessed on 1 December 2024)). The trial compared the effects of Group Music Therapy (GMT) with Recreational Choir Singing (RCS); GMT and RCS combined; and treatment as usual (TAU). Methods: In the intervention arms, the protocolized music interventions were delivered in care home units twice per week for three months, then once per week for three months. The primary outcome was depressive symptoms after six months, measured by MADRS. Secondary outcomes included well-being-EQ-5D-5L, Visual Analogue Scale (VAS); quality of life-QOL-AD; symptoms of dementia-SIB-8, NPI-Q; and caregiver distress-NPI-Q. The change in MADRS score from baseline to 6 months was assessed using a linear mixed-effects model. We report the multivariate model having both treatments as predictors, both unadjusted and adjusted, for the interaction between the treatments. Results: The UK trial started in 2022 after the pandemic lockdown, when 16 care home units were recruited and randomised, four per arm; 192 residents aged over 65 with depression and dementia participated. An ITT analysis of 146 participants retained at 6 months found neither intervention had a significant positive effect on any outcome. Significant unfavourable effects were found for RCS participants on MADRS, NPI symptom severity, and EQ-VAS. The combination of RCS + GMT had a detrimental effect on caregiver distress. Conclusions: MIDDEL UK findings do not support the use of GMT or RCS to alleviate depression in care home residents with dementia.