Aging, Cognitive Aging, Cognitive Impairment, Cognitively Normal Older Adults, Cognitive Training, Mild Cognitive Impairment
Conditions
Keywords
Aging, Brain Aging, Cognition, Cognitive Engagement, Mild Cognitive Impairment, Music, Music-based Intervention, Music Training, Older Adults
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPiano Improvisation
Piano Improvisation taught by a professional instructor for 12 weeks.
BEHAVIORALMusic Listening
Music Listening facilitated by a professional instructor for 12 weeks.
Sponsors
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
We will conduct a 2-arm randomized pilot trial.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 60 and over * Living independently in the community * Sufficient visual and hearing acuity (age-related to normal hearing loss, with assistive devices) as measured by audiometer * Less than three years of formal music training (as indicated by private music lessons does not include group or ensemble classes) and not currently reading or engaging in music performance * English fluency rated fairly well to well * Montreal Cognitive Assessment (MoCA) score of 22-30 or diagnosis of mild cognitive impairment * Not currently taking psychoactive medications, antidepressants, or sleep medications that could adversely affect cognitive abilities.
Exclusion criteria
* Medical diagnosis of dementia (any etiology) * Inability to move the hands or use all 10 digits (extensive arthritis, neuropathy, missing digits) * Score \< 22 on Montreal Cognitive Assessment (MoCA) * Current (but not prior) severe psychiatric disorder, serious medical condition (e.g., stroke, TIA) that would interfere with participation in the study * Poor English fluency * Musician or previously trained in jazz improvisation, more than three years of formal music instruction or training and/or currently engaged in musical performance * Plans to move out of the area within six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in Study | 12 weeks | This outcome is the proportion of participants who completed post-test assessments and remained in the study. |
| Adherence to Intervention | 12 weeks | This outcome will document participant adherence to the intervention. The percentage of participants who completed at least 6 out of 12 sessions. |
| Satisfaction With Intervention | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Grit Scale | Baseline and 12-week | 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. |
| Short Self-Regulation Questionnaire | Baseline and 12-weeks | 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. |
| Five Facets of Mindfulness | Baseline and 12-week | 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. |
| Florida Cognitive Activities Scale | Baseline and 12-week | 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. |
| National Institutes of Health ToolBox Self-Efficacy | Baseline and 12-week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 29 |
| Total | 53 |
Baseline characteristics
| Characteristic | Music Listening | Total | Piano Improvisation |
|---|---|---|---|
| Age, Continuous | 75.9 years STANDARD_DEVIATION 8.8 | 74.8 years STANDARD_DEVIATION 7.3 | 73.7 years STANDARD_DEVIATION 5.8 |
| Education | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 49 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 22 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 22 Participants | 11 Participants |
| Region of Enrollment United States | 29 Participants | 53 Participants | 24 Participants |
| Sex: Female, Male Female | 25 Participants | 45 Participants | 20 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 29 |
| other Total, other adverse events | 4 / 24 | 2 / 29 |
| serious Total, serious adverse events | 0 / 24 | 0 / 29 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Piano Improvisation Training | Adherence to Intervention | 21 Participants |
| Music Listening Training | Adherence to Intervention | 16 Participants |
Primary
Retention in Study
This outcome is the proportion of participants who completed post-test assessments and remained in the study.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Piano Improvisation Training | Retention in Study | 22 Participants |
| Music Listening Training | Retention in Study | 21 Participants |
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).
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Piano Improvisation Training | Satisfaction With Intervention | 24 Participants |
| Music Listening Training | Satisfaction With Intervention | 27 Participants |
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.
Time frame: Baseline and 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piano Improvisation Training | Five Facets of Mindfulness | 0.23 units on a scale | Standard Deviation 5.36 |
| Music Listening Training | Five Facets of Mindfulness | 0.79 units on a scale | Standard Deviation 4.73 |
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.
Time frame: Baseline and 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piano Improvisation Training | Florida Cognitive Activities Scale | 0.86 units on a scale | Standard Deviation 9.9 |
| Music Listening Training | Florida Cognitive Activities Scale | -1.95 units on a scale | Standard Deviation 12.04 |
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.
Time frame: Baseline and 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piano Improvisation Training | National Institutes of Health ToolBox Self-Efficacy | -0.50 units on a scale | Standard Deviation 4.41 |
| Music Listening Training | National Institutes of Health ToolBox Self-Efficacy | -0.63 units on a scale | Standard Deviation 5.06 |
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.
Time frame: Baseline and 12-week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piano Improvisation Training | Short Grit Scale | -0.86 units on a scale | Standard Deviation 3.62 |
| Music Listening Training | Short Grit Scale | -0.74 units on a scale | Standard Deviation 2.4 |
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.
Time frame: Baseline and 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Piano Improvisation Training | Short Self-Regulation Questionnaire | -0.32 units on a scale | Standard Deviation 10.02 |
| Music Listening Training | Short Self-Regulation Questionnaire | 0.95 units on a scale | Standard Deviation 11.93 |