Project CHROMA (Cognitive Health Research on Musical Arts)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Mean change from baseline in perseverative errors on the Wisconsin Card Sorting Test (WCST)
研究概览
简要总结
This study is designed to assess the therapeutic effect that music creativity engagement has on cognition and social/emotional well-being, with a special interest in quantifying the associated connectivity changes in the brain. Investigators will measure the effect that a creative music intervention has on health-related outcomes for mild cognitive impairment (MCI) patients using novel neural markers, laboratory-based cognitive tasks, assessments of loneliness, perceptions of stress, and social support.
详细描述
4.1 Design A six-week creative music course designed by Dr. Brandt and the other award-winning composers of Musiqa will be taught by graduate student composers from the Rice Shepherd School of Music. To make the course as accessible as possible, participants will not need to be able to read musical notation or have any prior musical background, and we will utilize established ways of effactively inspiring untrained musicians (26). It will meet 4 hours per day, for five days a week. The daily music workshops will have four components: listening, theory, performance, and creation (Table 1). Each week will be carefully scaled in difficulty, with the workshops becoming progressively more sophisticated.
4.2 Study Setting The study may take place at different locations depending on assessments. Screening assessments will take place over the phone with a research staff member. Interested individuals will complete the first visit for a baseline blood draw, health assessments, cognitive tasks, and social and emotional well-being assessments at Rice University's BioScience Research Collaborative (BRC) building, Suite 140. Participants will be brought to the BRC building by their caregiver or family member. Baseline neuroimaging will be performed at Houston Methodist Research Institute Translational Imaging Center. Participants will be randomly assigned to either the experimental group (music group) or the control group (non-music group).
Participants in the experimental group will undergo a 6-week music training headed by a musician associated with the Rice's Shepherd School of Music. The music intervention will take place on the main campus of Rice University or at the Bioscience Research Collaborative, Rm 707.
Additionally, the social, physical, and emotional wellbeing of the participant and the caregiver (if present) will be assessed with a battery of questionnaires before and after the intervention.
4.3 Recruitment and Data Collection Procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to limited funding, the research team is unable to conduct a truly randomized clinical trial. Research staff assessing baseline assessment (pre-intervention) and follow-up assessments (post-intervention) will not be intentionally masked. Participants also will not be masked. During the screening process, participants are told that they are randomized into a certain group: creative music and creative reading.They are informed which group they have been assigned to at their baseline visit because each group requires a different time commitment (music: requires coming in 3x a week for 6 weeks. reading/control: doesn't involve extra time commitment outside of the two research visits).
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean change from baseline in perseverative errors on the Wisconsin Card Sorting Test (WCST)
时间窗: Cognitive scores will be measured at enrollment and within one month since the completion of the music course.
The Wisconsin Card Sorting Test assess executive control. Scores on the WCST are based on percentages of categories achieved, errors, and perseveration errors. Greater number of perseverative errors indicate poorer executive control.
Change from baseline in functional resting state brain activity at follow-up visit.
时间窗: Functional magnetic resonance imaging will be obtained at enrollment and within one month since the completion of the music course.
Modularity and flexibility will act as quantifiers of neural activity. Modularity is the degree to which neural activity within a group of brain regions is more highly correlated than is activity between such groups, and flexibility is the dynamic reorganization of these groups.
Mean change from baseline in cognitive scores (digit span forward, digit span backward, digit span sequencing, and total raw score) on the digit span test of the Wechsler Adult Intelligence Scale (WAIS).
时间窗: Cognitive scores will be measured at enrollment and within one month since the completion of the music course.
Higher scores indicate greater working memory ability. Each subscale (forward, backward, and sequencing) has a maximum score of 16. The maximum total raw score is 48.
Mean change from baseline in inhibition and inhibition/switching trials on the color-word interference test of the Delis Kaplan Executive Function System (DKEFS)
时间窗: Cognitive scores will be measured at enrollment and within one month since the completion of the music course.
Higher scores for inhibition and inhibition/switching trials indicate greater executive functioning. Scaled and raw scores will be assessed. There is no minimum and maximum score.
Mean change from baseline in level of creativity using scores on Guilford's alternative Uses Divergent Thinking Test
时间窗: Creativity will be measured at enrollment and within one month since the completion of the music course.
Total scores are derived based on fluency, flexibility, originality, and elaboration. Higher scores indicate greater creativity. There is no max score.
Mean change in scores from baseline in perceived social support subscales of the Medical Outcomes Studies, including emotional support, tangible support, affectionate support, and positive social interactions.
时间窗: Creativity will be measured at enrollment and within one month since the completion of the music course.
Scores are transformed to a 0-100 scale. Higher scores on the self-report social support scale indicate a larger degree of perceived social support in each of these domains: emotional support, tangible support, affectionate support, and positive social interaction.
Mean change from baseline in quality of life scores each subscale of the SF-36
时间窗: Quality of life will be measured at enrollment and within one month since the completion of the music course.
Eight subscales measuring quality of life are scored out of 100. These subscales include: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general and health. Lower scores indicate greater disability.
Mean change from baseline in emotion regulation scores on the Emotional Regulation Scale
时间窗: Emotion regulation scores will be measured at enrollment and at the follow-up visit that will take place within one month after the completion of the music course.
The self-report questionnaire measures the extent to which one uses cognitive appraisal or suppression techniques to regulate emotions. Higher scores on each subscale indicate greater use of that regulation strategy. Scores are continuous. The emotional reappraisal scale has a max score of 42. The emotional suppression scale has a max score of 28.
Mean change from baseline in affect scores on the Positive and Negative Affect Scale
时间窗: Daily affect scores will be measured for 7 days after enrollment and 7 days after the final follow-up visit that will take place within 1 month after the completion of the music course.
Two scales measuring positive and negative affect. Scores range from 10-50 on each scale. Higher scores on positive affect scale indicate higher levels of positive affect. Lower scores on the negative affect scale indicate lower levels of negative affect.
次要结局
- Mean change in inflammation from enrollment (baseline) to follow-up visit(Blood will be drawn at enrollment and within one month after the completion of the music study (for experimental group).)