Music moves – Ettlingen dementia study: Protocol of a pragmatic randomised controlled trial

ABSTRACT Introduction Systematic reviews have shown the effectiveness of music in reducing the behavioural and psychological symptoms of dementia (BPSD). Effects of active (i.e. singing) compared to receptive (including vibroacoustic therapy) individual music therapy methods for specific BPSD/dementia sub-types are unclear, for example, that receptive methods (i.e. vibroacoustic therapy) increase parasympathetic responses and active music therapy improves cognitive and emotional functioning. Method A three-armed pragmatic randomised controlled trial will be conducted with German care home residents with dementia. Residents (N = 75) randomly assigned to the two intervention groups (individual active music therapy or individual vibroacoustic therapy) will receive two sessions/week for six weeks plus standard care. The control group will receive only standard care during data collection. The Neuropsychiatric Inventory-Nursing Home will assess BPSD; secondary outcomes include depression, quality of life, activities of daily living, health economy and musical engagement. Outcomes are measured at baseline, post-intervention (6 weeks), and 12-weeks post randomisation. MMSE is used as a screening measure. We hypothesise that individual active music therapy and individual vibroacoustic therapy will reduce BPSD significantly more than standard care. Secondary hypo-theses are increased quality of life and musical engagement and decreased depressivity and health resource usage. Discussion A greater relaxation response is expected in the receptive arm due to the massage-like vibration. Increased cognitive clarity and reduced depression are expected in the active arm. The trial is registered with the German Clinical Trials Register (DRKS00023233).