Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Neuropsychological Test: Change from baseline in Rey Auditory Verbal Learning Test scores at 3 months and 9 months
研究概览
简要总结
The objective of this study is to determine the impact of Art Therapy and Music Reminiscence Activity on cognition in community living elderly with Mild Cognitive Impairment (DSM V: Mild Neurocognitive Disorder) using a randomized control design.
Specifically, the structural cerebral changes that occur with the two interventions and the extent to which the therapies may reverse cognitive impairment and/or prevent further cognitive decline, will be determined.
The hypothesis is that participants in both active intervention arms will perform better on neuropsychological tests of cognition and will show positive changes on functional imaging studies compared to controls who will not receive any intervention. Participants in the interventions will also have positive changes in blood biomarkers, enhanced psychological well-being and reductions in anxiety and depressive symptoms compared to the control group. No a priori hypotheses were developed as to whether Art Therapy or Music Reminiscence Activity is more effective as the comparison is exploratory.
详细描述
Participants: 90 community-living elderly, with mild cognitive impairment.
Interventions: Participants will be randomized into 3 arms: Art Therapy, Music Reminiscence Activity or a Control arm. Sessions will be conducted weekly for 3 months and fortnightly for 6 months. Each intervention session will last for 40 minutes. The Control group will not receive any intervention and continue their life as usual.
Assessments: Demographic data will be collected at baseline. Neuropsychological tests of cognitive functioning will be done at baseline, 3 months and 9 months. Anxiety and depressive symptoms will be assessed at the 3 time-points. Blood sampling will occur at all time points (except control group, only at baseline and 9 months). Participants will also undergo a task-free brain fMRI scan at baseline and at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older person between 60 and 85 years of age, living in the community and fulfills the operational criteria/definition of MCI:
- •At least one age-education adjusted neuropsychological test Z score <-1.5
- •Do not meet DSM V criteria for a Major Neurocognitive Disorder
- •Memory/Cognitive complaint preferably corroborated by a reliable informant
- •Intact Activities of Daily Living
- •Functions independently
- •Does not have dementia
- •Able to travel to the data collection site on their own and participate in the activity
排除标准
- •Those who do not meet the above inclusion criteria (ie. do not have a MCI diagnosis)
- •Those with Dementia/Major Neurocognitive Disorder or Normal Ageing
- •Presence of a neurological condition e.g. epilepsy, Parkinson Disease, stroke
- •Presence of a major psychiatric disorder e.g. Major Depression, Psychoses
- •Terminal illness e.g. cancer
- •Presence of significant visual and/or hearing impairment and Color Blindness
- •Participants in another intervention study at the same time
研究组 & 干预措施
Art Therapy
Art Therapy, 24 sessions
干预措施: Art Therapy (Behavioral)
Music Reminiscence Activity
Music Reminiscence Activity, 24 sessions
干预措施: Music Reminiscence Activity (Behavioral)
Control
Participants will not participate in either of the interventions and will continue life as usual.
结局指标
主要结局
Neuropsychological Test: Change from baseline in Rey Auditory Verbal Learning Test scores at 3 months and 9 months
时间窗: Measured at Baseline, 3 months and 9 months
Measure: Number of items from a list of 15 items participant is able to recall immediately and 30 minutes later.
Neuropsychological Test: Change from baseline in Digit Span Task scores at 3 months and 9 months
时间窗: Measured at Baseline, 3 months and 9 months
Digit Span Task \[(Digit Span Forward (DSF) and Digit Span Backward (DSB)\] DSF Measure: 1 point for each correct sub-item response, Minimum: 0; Maximum 16 DSB Measure: 1 point for each correct sub-item response, Minimum: 0; Maximum 14
Neuropsychological Test: Change from baseline in Colour Trails Test scores at 3 months and 9 months
时间窗: Measured at Baseline, 3 months and 9 months
Colour Trails Test (CTT) 1 and 2 Measure: Time to completion, in seconds for Trial 1 and Trial 2. Time Limit: 240s
Change from baseline fMRI scan at 3 months
时间窗: Measured at Baseline and 3 months
Task-free Functional Magnetic Resonance Imaging (fMRI) will be employed to examine changes in functional connectivity.
Neuropsychological Test: Change from baseline in Block Design Test scores at 3 months and 9 months
时间窗: Measured at Baseline, 3 months and 9 months
Block Design (sub-test of the Wechsler Adult Intelligence Scale Tests) Measure: Respective sub-item test scores, based on time of completion and accuracy; Maximum score: 68
次要结局
- Change from baseline telomere lengths at 3 months and 9 months(Measured at Baseline, 3 months and 9 months)
研究者
Rathi Mahendran
Senior Consultant Psychiatrist
National University of Singapore