Music Interventions for Dementia and Depression in Elderly Care: International Cluster-randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,021
- 试验地点
- 12
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
This study evaluates the effectiveness of two music-based approaches - group music therapy and recreational choir singing - for reducing depression symptoms in people living with dementia. It also examines mechanisms and heterogeneity of treatment effects.
详细描述
Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial carer burden, and high societal costs.
Music interventions represent a highly promising type of non-pharmacological interventions for both dementia and depression in older adults. They are widely used, but have yet to be rigorously tested in large trials.
The MIDDEL trial is the largest trial of music interventions to date, and the first to compare different music-based interventions - group music therapy (GMT), and recreational choir singing (RCS) - alone and in combination across countries.
MIDDEL is designed as a large, pragmatic, international cluster-randomised controlled trial with a 2x2 factorial design that will compare the effects of GMT, RCS, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms.
Study sites will be located in Australia and in five European countries, and a total of 100 care home units will be randomised to one of the four study conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of assessors will be ensured by using assessors who do not participate in the daily care of each unit. Assessors will also remind participants not to reveal the unit's allocation to them. At the time of the last assessment, success of blinding will be verified by asking assessors whether they inadvertently discovered the unit's allocation. Intervention providers and study participants (PLWD and staff) cannot be blinded due to the nature of the interventions. However, efforts will be made to ensure that no differential expectations are created and equipoise is maintained (e.g., by careful wording of the patient information and consent form).
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •resident (full-time, 24h/day) at a participating care home;
- •dementia as indicated by a Clinical Dementia Rating score of 0.5 or more and a Mini-Mental State Examination (MMSE) score of 26 or less;
- •at least mild depressive symptoms, as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 8;
- •a clinical diagnosis of dementia according to ICD-10 research criteria;
- •have given written informed consent (may be assent by proxy for those unable to provide consent themselves).
排除标准
- •diagnosis of schizophrenia or Parkinson's disease;
- •severe hearing-impairment;
- •in short-term care;
- •unable to tolerate sitting in a chair for the duration of the sessions.
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: 6 months
10-item scale where each item is rated from 0 to 6 ('no abnormality' to 'severe'), yielding a total sum score between 0 and 60, with higher values indicating more severe symptom levels.
次要结局
- Neuropsychiatric Inventory - Questionnaire (NPI-Q): distress(12 months)
- All-cause mortality (time to death)(up 24 months)
- Any adverse event [Safety](12 months)
- Professional Care Team Burden Scale(12 months)
- Montgomery-Åsberg Depression Rating Scale (MADRS)(up to 24 months)
- EuroQol (EQ-5D)(12 months)
- Quality of Life in Alzheimer´s Dementia (QOL-AD)(12 months)
- Any increase in medication use (binary, yes/no)(12 months)
- Neuropsychiatric Inventory - Questionnaire (NPI-Q): severity(12 months)
- Clinical Dementia Rating (CDR)(12 months)
- Costs(12 months)
- Days on sick leave of care staff(12 months)