Dementia is often associated with Neuropsychiatric Symptoms (NPS) such as agitation, hallucinations, anxiety, that can cause distress for the resident with dementia in long-term care settings and can impose emotional burden on the environment. NPS are often treated with psychotropic drugs, which, however, frequently cause side effects. Alternatively, non-pharmacological interventions can improve well-being and maintain an optimal quality of life (QoL) of those living with dementia. Music therapy is a non-pharmacological intervention that can reduce NPS and improve well-being of persons with dementia.

The main aim of this study is to assess the effects of individual music therapy on well-being controlled for providing individual attention in nursing home residents with dementia and NPS.

The research is conducted at eight facilities of one nursing home organization in the Netherlands. The participants in the intervention group receive 30 minutes of individual music therapy (MT) in their own room by a music therapist twice a week for 12 weeks. The participants in the control group receive 30 minutes of individual attention in their own room by a volunteer twice a week for 12 weeks. Assessments will be done at baseline, 6 weeks and 12 weeks. An independent observer, blinded for the intervention or control condition, assesses directly observed well-being (primary outcome) and pain before and after the sessions. Nurses assess other secondary outcomes unblinded, i.e., perceived quality of life and NPS assessed with validated scales. The sleepy duration is will be assessed by a wrist device called MotionWatch. Information about psychotropic drug use is derived from electronic medical chart review.

We will present baseline data and preliminary results.

The outcomes refer to both short-term and long-term effects consistent with therapeutic goals of care for a longer term. We hope to overcome limitations of previous study designs such as non- blinded designs and pragmatic designs in which music facilitators that were not only music therapists but occupational therapists and nurses. This study should lead to more focused recommendations for practice and further research into non-pharmacological interventions in dementia.

The trial is registered at the International Clinical Trials Registry Platform (ICTRP) search portal in the Netherlands Trial Registration number NL7708, registration date 04-05-2019.