Mahendran Rathi, Rawtaer Iris, Fam Johnson, Wong Jonathan, Kumar Alan Prem, Gandhi Mihir, Jing Kenny Xu, Feng Lei, Kua Ee Heok
Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Republic of Singapore.
Department of Psychological Medicine, National University Hospital, Tower Block, Level 9, 1E Kent Ridge Road, Singapore, Republic of Singapore.
Trials. 2017 Jul 12;18(1):324. doi: 10.1186/s13063-017-2080-7.
Attention has shifted to the use of non-pharmacological interventions to prevent cognitive decline as a preventive strategy, as well as for those at risk and those with mild cognitive impairment. Early introduction of psycho-social interventions can address cognitive decline and significantly impact quality of life and the wellbeing of elderly individuals. This pilot study explores the feasibility of using art therapy and music reminiscence activity to improve the cognition of community living elderly with mild cognitive impairment.
METHODS/DESIGN: This open-label, interventional study involves a parallel randomized controlled trial design with three arms (two intervention arms and a control group) over a nine-month period. Participants will be community-living elderly individuals aged 60-85 years, both genders, who meet predefined inclusion and exclusion criteria. In the initial three months, interventions will be provided weekly and for the remaining six months fortnightly. A sample size of 90 participants is targeted based on expected neuropsychological test performance, a primary outcome measure, and drop-out rates. The randomization procedure will be carried out via a web-based randomization system. Interventions will be provided by trained staff with a control group not receiving any intervention but continuing life as usual. Assessments will be done at baseline, three months, and nine months, and include neuroimaging to measure cerebral changes and neuropsychological tests to measure for changes in cognition. Secondary outcome measures will include mood changes in anxiety and depression and telomere lengths. Statistical analysis will be undertaken by statisticians; all efficacy analysis will be carried out on an intention-to-treat basis. Primary and secondary outcomes will be modeled using the linear mixed model for repeated measurements and further analysis may be undertaken to adjust for potential confounders.
This will be the first study to compare the effectiveness of art therapy and music reminiscence activity in a randomized controlled trial. We expect that the trial will provide useful evidence for developing psychosocial interventions for the elderly with mild cognitive impairment.
The study was registered on 7 July 2016 at Clinical Trials.gov, a service of the US National Institute of Health ( NCT02854085 ), retrospectively.
作为一种预防策略，注意力已转向使用非药物干预措施来预防认知能力下降，对于有风险的人群以及轻度认知障碍患者亦是如此。早期引入心理社会干预措施可以解决认知能力下降问题，并对老年人的生活质量和幸福感产生重大影响。这项试点研究探讨了使用艺术疗法和音乐回忆活动来改善社区生活的轻度认知障碍老年人认知能力的可行性。
方法/设计：这项开放标签的干预性研究采用平行随机对照试验设计，为期九个月，分为三个组（两个干预组和一个对照组）。参与者将是年龄在60 - 85岁之间、符合预定义纳入和排除标准的社区居住老年人，不限性别。在最初的三个月里，每周进行干预，在其余六个月里每两周进行一次干预。根据预期的神经心理学测试表现（一项主要结局指标）和脱落率，目标样本量为90名参与者。随机化程序将通过基于网络的随机化系统进行。干预将由经过培训的工作人员提供，对照组不接受任何干预，继续照常生活。评估将在基线、三个月和九个月时进行，包括测量脑部变化的神经影像学检查和测量认知变化的神经心理学测试。次要结局指标将包括焦虑和抑郁情绪变化以及端粒长度。统计分析将由统计学家进行；所有疗效分析将基于意向性分析原则进行。主要和次要结局将使用重复测量的线性混合模型进行建模，可能会进行进一步分析以调整潜在的混杂因素。
这将是第一项在随机对照试验中比较艺术疗法和音乐回忆活动有效性的研究。我们预计该试验将为开发针对轻度认知障碍老年人的心理社会干预措施提供有用的证据。
该研究于2016年7月7日在美国国立卫生研究院的一项服务ClinicalTrials.gov上进行了回顾性注册（NCT02854085）。
