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Clinical Trials/NCT05980286
NCT05980286CompletedNot Applicable

Impact of Music Improvisation Training on Cognitive Function in Older Adults

University of California, San Francisco2 sites in 1 country53 target enrollmentStarted: October 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
2
Primary Endpoint
Retention in Study

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Retention in Study

Time Frame: 12 weeks

This outcome is the proportion of participants who completed post-test assessments and remained in the study.

Adherence to Intervention

Time Frame: 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

Time Frame: 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).

Retention in Study

Time Frame: 12 weeks

This outcome is the proportion of participants who completed post-test assessments and remained in the study.

Adherence to Intervention

Time Frame: 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

Time Frame: 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 Outcomes

  • Short Self-Regulation Questionnaire(Baseline and 12-weeks)
  • Florida Cognitive Activities Scale(Baseline and 12-week)
  • National Institutes of Health ToolBox Self-Efficacy(Baseline and 12-week)
  • Short Grit Scale(Baseline and 12-week)
  • Five Facets of Mindfulness(Baseline and 12-week)
  • Short Self-Regulation Questionnaire(Baseline and 12-weeks)
  • Florida Cognitive Activities Scale(Baseline and 12-week)
  • National Institutes of Health ToolBox Self-Efficacy(Baseline and 12-week)
  • Short Grit Scale(Baseline and 12-week)
  • Five Facets of Mindfulness(Baseline and 12-week)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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