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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61AG073669 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This project will develop and test the effects and mechanisms of a music improvisation training intervention on self-regulation of older adults with and without MCI. The investigator's overall hypothesis is that improvisation training will lead to improvements in self-regulation, compared to controls, and that improvisation training will be associated with specific changes in prefrontal brain networks and ultimately cognitive engagement.
Approximately 5.8 million adults age 60 and over in the United States live with Alzheimer disease and related dementias (AD/ADRD) at a cost of $290 billion per year. Older adults with mild cognitive impairment (MCI), an intermediate stage between typical aging and dementia, are 3-5 times more likely to progress to AD than those with normal cognition. Late-life engagement in cognitively challenging activities is associated with decreased risk of cognitive decline, and there is a need to address cognitive inactivity. Music interventions are a promising strategy to address late-life cognitive inactivity. Music training can change brain structure and function in non-musician adults, thereby leading to cognitive, perceptual, and psychosocial advantages. These changes in cognitive function are thought to occur because the multimodal, complex nature of music facilitates training-induced neural plasticity. However, the mechanisms are not yet understood, and most studies used traditional or rote keyboard training techniques. Music training based on improvisation principles-the spontaneous generation of musical melodies and rhythms-will likely have more potent effects on cognition and brain function. Improvisation facilitates cognitive flexibility, self-monitoring, novel idea generation, execution of unplanned motor sequences and entrance into a state of flow. Biologically, improvisation is associated with distinct neural patterns involving activation of prefrontal networks and other brain networks that are affected by aging. As a mechanism of behavior change, it is likely that improvisation training will uniquely improve self-regulation (the ability to monitor and control one's own behavior, emotions, or thoughts and modify to situational demands). Yet, no research has tested whether improvisation training can improve self-regulation and facilitate maintenance of cognitively challenging activities among older adults with and without MCI. This project will develop and test the effects and mechanisms of a music improvisation training intervention on self-regulation of older adults with and without MCI. Our overall hypothesis is that improvisation training will lead to improvements in self-regulation, compared to controls, and that improvisation training will be associated with specific changes in prefrontal brain networks and ultimately cognitive engagement. Our project has two phases. In the R61 phase, the study will develop a music improvisation training intervention that aims to improve self-regulation among older adults with and without MCI and conduct a 2-arm randomized pilot study to (i) examine feasibility and acceptability of the intervention and study methods and (ii) determine its effects on the hypothesized mechanism of self-regulation. If milestones are met, the study will proceed to the R33 phase and conduct a randomized mechanistic trial to examine the effects of the intervention, compared to an attention control, on self-regulation and cognitive engagement among older adults with and without MCI. The findings from this study will improve our understanding of the underlying mechanisms of how music training interventions can facilitate behavior change to maintain health of older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piano Improvisation Training | Experimental | This intervention will involve group piano improvisation training sessions once a week for 12 weeks, in addition to daily in-home practice for 4-5 days. |
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| Music Listening Training | Active Comparator | The music listening condition will involve group music listening sessions (led by a trained instructor) once a week for 12 weeks and daily in-home music listening practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piano Improvisation | Behavioral | Piano Improvisation taught by a professional instructor for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Study | This outcome is the proportion of participants who completed post-test assessments and remained in the study. | 12 weeks |
| Adherence to Intervention | This outcome will document participant adherence to the intervention. The percentage of participants who completed at least 6 out of 12 sessions. | 12 weeks |
| Satisfaction With Intervention | This survey item was part of a longer feasibility and acceptability survey that was created for this study. This question measures the degree to which participants reported being satisfied with the intervention. This item was "Overall, how would you rate the quality of the sessions?" on a 5-point scale (1-poor, 2-fair, 3-good, 4-very good, or 5-excellent). Scores range from 1-5, with higher scores indicating better satisfaction. We report the percentage of participants who rated the intervention as good to excellent (scores of 3-5). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Short Self-Regulation Questionnaire | The Short Self-Regulation Questionnaire is a 31-item measure of the ability to regulate behavior in order to achieve desired future outcomes. This is the short form of the Self-Regulation Questionnaire (SRQ) developed by Brown et al. in 1999. Each item was scored on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The questionnaire scores range from 31 to 155, with higher scores indicating better self-regulation behavior. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julene Johnson, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Disability and Aging Services (DAS) Sites | San Francisco | California | 94103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Piano Improvisation | This intervention will involve group piano improvisation training sessions once a week for 12 weeks, in addition to daily in-home practice for 4-5 days. |
| FG001 | Music Listening | The music listening condition will involve group music listening sessions (led by a trained instructor) once a week for 12 weeks and daily in-home music listening practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Piano Improvisation | This intervention will involve group piano improvisation training sessions once a week for 12 weeks, in addition to daily in-home practice for 4-5 days. |
| BG001 | Music Listening |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention in Study | This outcome is the proportion of participants who completed post-test assessments and remained in the study. | Posted | Count of Participants | Participants | 12 weeks |
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up to 14 weeks, which represented the week when the baseline assessment was done, the 12-week intervention, and the week when the post-intervention assessment was done.
Adverse events were graded from mild to severe.Potential mild adverse effects while completing a questionnaire could include boredom, fatigue, frustration, and loss of confidentiality. Potential mild adverse events related to piano improvisation training may include frustration, stress, and mild musculoskeletal fatigue. Moderate adverse events may include the falls and moderate musculoskeletal fatigue or pain. Severe adverse events might include cardiovascular events and death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Piano Improvisation | This intervention will involve group piano improvisation training sessions once a week for 12 weeks, in addition to daily in-home practice for 4-5 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal fatige | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Two participants experienced pain in the hands during keyboard practice |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julene Johnson, Professor | University of California, San Francisco | 415-476-1106 | Julene.Johnson@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2022 | Jun 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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We will conduct a 2-arm randomized pilot trial.
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| Music Listening | Behavioral | Music Listening facilitated by a professional instructor for 12 weeks. |
|
| Baseline and 12-weeks |
| Florida Cognitive Activities Scale | The Florida Cognitive Activities Scale is a self-report 25-item questionnaire (0-never to 5-daily) used to assess frequency of engagement in cognitive activity for older adults. A Total Cognitive Activity (TCA) score is calculated by summing scores on all 25 items, with scores ranging from 0-100. Higher scores indicate more frequent engagement in cognitive activity. | Baseline and 12-week |
| National Institutes of Health ToolBox Self-Efficacy | The NIH Toolbox Self-Efficacy Scale is a 10-item self-reported measure that assesses belief in one's capacity to manage and have control over meaningful events in life. Scores for each item range from 1 to 5 (never to very often) with scores ranging from 10-50. Higher scores indicate higher self-efficacy. | Baseline and 12-week |
| Short Grit Scale | The Short Grit Scale (Grit-S) is a self-report, 8-item questionnaire that measures the extent to which individuals are able to maintain focus and interest and persevere in obtaining long-term goals. The Short Grit Scale (Grit-S) retains the 2-factor structure of the original Grit Scale (Duckworth, Peterson, Matthews, & Kelly, 2007) with 4 fewer items and improved psychometric properties. Scores for each item range from 1 to 5, with overall scores being calculated by added up all points and dividing by 8. Scores range from 1-5. Higher scores indicate a higher level of "grit," or perseverance. | Baseline and 12-week |
| Five Facets of Mindfulness | Measures components of mindfulness, which is a tendency to attend to the present moment with a non-judgemental attitude. Scores for each item range from 1 to 5 (never to always true), with higher scores representing lower non-judgemental attitude.The Total FFMQ can be divided by 39 to get an average item score. Total score ranges from 39 to 195, and higher scores suggest a better mindful self-awareness. | Baseline and 12-week |
The music listening condition will involve group music listening sessions (led by a trained instructor) once a week for 12 weeks and daily in-home music listening practice.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | San Francisco County | Count of Participants | Participants | No |
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| Education | Education: High school or less | Count of Participants | Participants |
|
|
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| Primary | Adherence to Intervention | This outcome will document participant adherence to the intervention. The percentage of participants who completed at least 6 out of 12 sessions. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Primary | Satisfaction With Intervention | This survey item was part of a longer feasibility and acceptability survey that was created for this study. This question measures the degree to which participants reported being satisfied with the intervention. This item was "Overall, how would you rate the quality of the sessions?" on a 5-point scale (1-poor, 2-fair, 3-good, 4-very good, or 5-excellent). Scores range from 1-5, with higher scores indicating better satisfaction. We report the percentage of participants who rated the intervention as good to excellent (scores of 3-5). | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Short Self-Regulation Questionnaire | The Short Self-Regulation Questionnaire is a 31-item measure of the ability to regulate behavior in order to achieve desired future outcomes. This is the short form of the Self-Regulation Questionnaire (SRQ) developed by Brown et al. in 1999. Each item was scored on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The questionnaire scores range from 31 to 155, with higher scores indicating better self-regulation behavior. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-weeks |
|
|
|
| Secondary | Florida Cognitive Activities Scale | The Florida Cognitive Activities Scale is a self-report 25-item questionnaire (0-never to 5-daily) used to assess frequency of engagement in cognitive activity for older adults. A Total Cognitive Activity (TCA) score is calculated by summing scores on all 25 items, with scores ranging from 0-100. Higher scores indicate more frequent engagement in cognitive activity. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-week |
|
|
|
| Secondary | National Institutes of Health ToolBox Self-Efficacy | The NIH Toolbox Self-Efficacy Scale is a 10-item self-reported measure that assesses belief in one's capacity to manage and have control over meaningful events in life. Scores for each item range from 1 to 5 (never to very often) with scores ranging from 10-50. Higher scores indicate higher self-efficacy. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-week |
|
|
|
| Secondary | Short Grit Scale | The Short Grit Scale (Grit-S) is a self-report, 8-item questionnaire that measures the extent to which individuals are able to maintain focus and interest and persevere in obtaining long-term goals. The Short Grit Scale (Grit-S) retains the 2-factor structure of the original Grit Scale (Duckworth, Peterson, Matthews, & Kelly, 2007) with 4 fewer items and improved psychometric properties. Scores for each item range from 1 to 5, with overall scores being calculated by added up all points and dividing by 8. Scores range from 1-5. Higher scores indicate a higher level of "grit," or perseverance. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-week |
|
|
|
| Secondary | Five Facets of Mindfulness | Measures components of mindfulness, which is a tendency to attend to the present moment with a non-judgemental attitude. Scores for each item range from 1 to 5 (never to always true), with higher scores representing lower non-judgemental attitude.The Total FFMQ can be divided by 39 to get an average item score. Total score ranges from 39 to 195, and higher scores suggest a better mindful self-awareness. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12-week |
|
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|
| 0 |
| 24 |
| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | Music Listening | The music listening condition will involve group music listening sessions (led by a trained instructor) once a week for 12 weeks and daily in-home music listening practice. | 0 | 29 | 0 | 29 | 2 | 29 |
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| Frustration with learning new skill | General disorders | Systematic Assessment | Two participants experienced frustration with learning a new skill |
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| Frustration with participants' attendance | General disorders | Systematic Assessment | Two participants expressed frustration with participants who missed intervention sessions |
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