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

痴呆症和抑郁症在老年人中非常普遍和共病，并与个人痛苦，照顾者负担以及高昂和不断上升的社会成本有关。在全球范围内，2017年约有5000万人患有痴呆症;预计这一数字在2030年将达到8200万，2050年将达到1.52亿。痴呆症的社会成本也相应增加。抑郁症是全球残疾的主要原因。在老年人中，它以复杂的方式与痴呆症共同发生并相互作用。抑郁症会导致认知障碍，并可能增加患痴呆症的风险;相反，抑郁症在痴呆症的早期阶段非常常见，并且经常因进入长期护理机构而加剧。精神药物疗效有限，副作用严重，但通常用于减少痴呆后期的挑战行为。在现有的非药物干预措施中，有一些支持证据，音乐干预利用音乐的能力来引发情绪反应和检索记忆。负责处理音乐的大脑区域，特别是熟悉的歌曲，即使在晚期痴呆症中也可能被保留下来。两种常见的基于团体的音乐干预是团体音乐治疗（GMT）和娱乐合唱团唱歌（RCS）。GMT需要一名合格的音乐治疗师，并包括各种活动（从唱歌到器乐制作到听音乐），重点是互动和交流; RCS由合唱团领导人提供便利，并集中在唱歌上。GMT有更多的研究证据，在科克伦综述中进行了总结;1 RCS有新的证据，但更具可扩展性，可以与更大的群体进行，可能更具成本效益。MIDDEL的主要目标是提供高质量的证据，证明GMT，RCS，GMT+RCS或单独标准治疗的相对有效性，以减少老年痴呆症护理院居民的抑郁症状。其次，MIDDEL旨在研究GMT和RCS对居民和护理人员的直接和下游结果的影响。我们假设GMT和RCS依赖于生物学、心理学（认知和情感）和社会机制的组合，但程度不同。情绪处理，例如使用音乐互动来反映传记或当前的关系，可能是GMT中最重要的，导致寻找意义和重新获得方向，从而减少激动和相关的神经精神症状。相比之下，认知处理，例如通过学习和记忆音乐片段，是RCS的核心机制。总之，我们预计GMT和RCS都能减轻抑郁症状，但作用模式不同; GMT和RCS的协同作用可能通过不同途径的共激活而发生;亚组间的作用也存在相应差异。目前的建议包括长达12个月的成本分析和临床效果分析。全面的成本效益分析和长期评价计划不在本提案的范围之内，但将另行规划。

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.