Evaluation of Cognitive Effects Generated by Music Therapy for Older Adults With Cognitive Impairment Living in Care Homes - a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Music Cognitive Test (MCT)
研究概览
简要总结
This research aims to investigate whether the use of music-improvisation therapy for older adult participants can lead to improvements in cognitive ability levels, especially in attentional functions. Very relevant reviews highlight studies that demonstrate the effectiveness of Music Therapy training. However, only a few are based on randomised criteria and structured methodological approaches. This affects the generalizability of findings, as to whether Music Therapy interventions are effective in improving cognitive functions, mood, and quality of life of people with cognitive decline.
In order to make a difference, there is a need for more studies that are structured [i] according to rigorous empirical criteria (namely involving random assignment of participants to activity groups), [ii] and that gather scientific evidence, based on both standardized cognitive tests and biomarkers (hormones: Cortisol, or stress hormone, and DHEA or aging hormone; brain signal, EEG; Physiology: Respiratory Sinus Arrhythmia).
In this RCT study, the investigator investigated the effect of 4-month music therapy vs Storytelling program for older adults with cognitive decline, living in care homes.
详细描述
RESEARCH QUESTIONS
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- What are the cognitive-neuropsychological benefits of Music Therapy activities in older adults with mild-moderate cognitive impairment?
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- What are the behavioural-wellbeing benefits of Music Therapy activities in older adults with mild-moderate cognitive impairment?
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- Can Music Therapy influence the psychophysiological domains (i.e., cortisol/DHEA ratio, RSA) of people with mild-moderate cognitive impairment?
Participants A power sample size calculation with an effect size (f) = 0.26, α= 0.05, Power (1-β) = 0.80 (any level over 0.80 is considered satisfactory) was performed with G*Power software yielding an overall n=32 minimum participant sample.
Participants were randomly allocated by a blind researcher to a MT (experimental group) or a ST intervention (active control group) using a computerised randomisation method.
To minimise a possible drop-out rate with a consequent loss of power, a total of 50 participants were recruited, of which 42 completed the study, 23 in the experimental group and 19 in the control group. All participants underwent a neuropsychological test battery examination. No baseline differences were found between the experimental and control group as to screening demographic variables, MMSE, Cognitive Reserve and a battery of cognitive and behavioural tests. Hence the two groups were equivalent at the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥60yrs
- •No significant hearing impairment that would negatively interfere with the music-based interventions
- •Fluent in English
- •Cognitive impairment: mild MMSE= 18-23, moderate MMSE= 10-17
排除标准
- •Presence of severe motor deficits that would not allow individuals to participate in the intervention
- •Having taken part in a cognitive training programme or Music Therapy programme within the last 6 months.
结局指标
主要结局
Music Cognitive Test (MCT)
时间窗: Change in MCT score from baseline (time 0) to post-intervention period (+4 months).
The Music Cognitive Test (Mangiacotti et al., 2022) which is a music-based cognitive screening test, specifically designed to measure possible changes brought by music-based interventions. The score range is 0-52 points; A higher score indicates better cognitive performance, with a score of 45 or above considered normal cognitive functioning.
Cornell Scale for Depression in Dementia (CSDD, Alexopoulos et al., 1988)
时间窗: Change in CSDD score from baseline (time 0) to post-intervention period (+4 months).
The Cornell Scale for Depression in Dementia (CSDD) is a test to screen depressive symptoms in older adults with dementia and cognitive impairment. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The score range is 0-38 with scores above 10 indicating a probable major depression. Scores above 18 indicate a definite major depression.
次要结局
- Clock Drawing test (CDT, Mondini et al., 2011)(Change in CDT score from baseline (time 0) to post-intervention period (+4 months).)
- Quality of Life in Alzheimer's Disease (QoL, Logsdon et al., 2002).(Change in QoL score from baseline (time 0) to post-intervention period (+4 months).)
- Bristol Activities of Daily Living Scale (BADL, Bucks et al., 1996)(Change in BADL score from baseline (time 0) to post-intervention period (+4 months).)
- The Satisfaction With Life Scale (SWLS, Diener et al., 1985).(Change in SWLS score from baseline (time 0) to post-intervention period (+4 months).)
- Tangled Figure Test (TFT, in Mondini et al., 2011, adaptation of Rey, 1964)(Change in TFT score from baseline (time 0) to post-intervention period (+4 months).)
- Neuropsychiatric Inventory (NPI, Cummings et al., 1994)(Change in NPI score from baseline (time 0) to post-intervention period (+4 months).)
- Montreal Cognitive Assessment (MoCA, Nasreddine et al., 2005)(Change in MoCa score from baseline (time 0) to post-intervention period (+4 months).)
- Trail Making Test (TMT-A, in Mondini et al., 2011)(Change in TMT-A score from baseline (time 0) to post-intervention period (+4 months).)
- Verbal Fluency test, Phonemic & Semantic (VFT, Ardila et al., 2006; Machado et al., 2009)(Change in VTF score from baseline (time 0) to post-intervention period (+4 months).)
研究者
Anthony Mangiacotti
Principal Investigator
Middlesex University