Music Interventions for Dementia and Depression in ELderly care: International cluster-randomised trial (MIDDEL)

Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, caregiver burden, and high and rising societal costs. Globally, around 50 million people were living with dementia in 2017; this number is predicted to reach 82 million in 2030 and 152 million in 2050. The societal costs of dementia are increasing accordingly. Depression is the leading cause of disability worldwide. In older adults, it co-occurs and interacts with dementia in complex ways. Depression can cause cognitive impairment and may increase the risk of developing dementia; conversely, depression is very common in the early stages of dementia and often exacerbated by admission to a long-term care facility. Psychotropic medication has limited efficacy and severe adverse effects, but is often used to reduce challenging behaviours in later stages of dementia. Among available non-pharmacological interventions that have some supporting evidence, music interventions use the ability of music to elicit emotional responses and retrieve memories. Brain regions responsible for processing music, particularly known familiar songs, may be preserved even in late-stage dementia. Two common group-based music interventions are group music therapy (GMT) and recreational choir singing (RCS). GMT requires a qualified music therapist and includes a variety of activities (ranging from singing through instrumental music-making to music listening), with a focus on interaction and communication; RCS is facilitated by a choir leader and focuses centrally on singing. GMT has more research evidence, summarized in a Cochrane review;1 RCS has emerging evidence, but is more scalable, can be conducted with larger groups, and may be more cost-effective.

The primary objective of MIDDEL is to provide high-quality evidence of the comparative effectiveness of GMT, RCS, GMT+RCS, or standard care alone, for reducing depression symptoms in care home residents with dementia. Second, MIDDEL aims to examine effects of GMT and RCS on direct and downstream outcomes in residents and care staff. We hypothesise that GMT and RCS rely on a combination of biological, psychological (cognitive and emotional), and social mechanisms, but to different degrees. Emotional processing, such as using musical interactions to reflect on biographical or current relationships, may be most important in GMT, leading to finding meaning and regaining orientation, and thereby to reduced agitation and related neuropsychiatric symptoms. In contrast, cognitive processing, e.g. through learning and memorising music pieces, is a central mechanism in RCS. In summary, we expect both GMT and RCS to reduce depression symptoms, but to differ in the pattern of effects; synergistic effects of GMT and RCS may occur through co-activation of different pathways; with according differences in effects across subgroups. The present proposal includes a cost analysis and analysis of clinical effects up to 12 months. Plans for a full cost-effectiveness analysis and longer-term evaluation are beyond the scope of this proposal, but are planned separately.

MIDDEL is a multinational pragmatic cluster-randomised trial to determine the effects of two complex music interventions on older adults living in residential care with dementia and depression. As highly prevalent and comorbid conditions in older adults, dementia and depression are associated with individual distress and high and rising societal costs. This trial will provide generalisable results concerning the comparative effects of group music therapy (GMT), recreational choir singing (RCS), their combination, or standard care, in older adults with dementia and depression, including long-term effects on key outcomes (depression, behavioural problems, quality of life, costs). The trial will also enable modelling of trajectories of change and will thereby contribute to an improved understanding of the mechanisms of music interventions. Building on promising results from previous small-scale randomised controlled trials and pilot investigations, this trial will have adequate power to determine clinical effects as well as to explain variation in treatment effects in relation to patient characteristics, thereby contributing to the development of precision medicine in line with the JPND call. Music-based interventions are relevant for both genders and can be tailored to people with different cultural backgrounds. By improving existing interventions and providing evidence-based guidance on their application or discontinuation, this trial is anticipated to benefit the rapidly rising number of people living with dementia, their caregivers, and health systems across countries. A comprehensive set of patient- and service-relevant core outcomes, as well as biomarkers, will be measured. The large sample will ensure sufficient power for stratification of subgroups and to establish the influence of biomarkers on the overall effect of the interventions.

There are three outputs of this study over and above the results of the study analyses. They include (i) a consensus manual for group music therapy, (ii) a consensus manual to guide recreational choral singing, and (iii) a template for public participation and involvement in this kind of study; applied research on music activities in care home settings. Here, the impact plan for the UK is outlined, and it is likely to be adapted for the other countries in the study (Norway, Denmark, the Netherlands, Turkey, Germany, Italy and Australia).

We have broadly identified key stakeholders in the study as (1) residents, relatives, and care staff, (2) advocacy organisations or campaigns with an interest in residential care, in the mental wellbeing of older people in general, and in the development of music-led interventions for wellbeing, (3) providers of care in the commercial or not-for-profit sectors and (3) policymakers, inspectors and commissioners of care provision. The means to engage these stakeholders with the study outputs are as follows.

1. Professional design and branding will be commissioned through the University of Nottingham Communications department to present and promote the study at the outset.

2. We will develop a marketing pack containing approved descriptions of the study written for lay audiences in various forms: tweets, blogs, summaries and lengthier descriptions. This may include photographic images, video and audio with appropriate releases from the subjects.

3. A website will be set up at the University of Nottingham and linked to other relevant websites. This will act as a repository for the information that we disseminate.

4 .A customer relationship database will be built up for the UK, with appropriate data protection measures, seeking consent from the relevant stakeholders to be kept informed about the study and its outputs.

5. Updates will be emailed to consenting stakeholders on a 6-monthly basis to brief them on the study and direct them to the website. These will feature the three key outputs leading up to the study results, and the final findings of the research.

6. Press releases will be produced and distributed alongside each of the main outputs.