- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05980286
Impact of Music Improvisation Training on Cognitive Function in Older Adults
December 1, 2025 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94103
- Department of Disability and Aging Services (DAS) Sites
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Piano Improvisation Training
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.
|
Piano Improvisation taught by a professional instructor for 12 weeks.
|
|
Active Comparator: Music Listening Training
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.
|
Music Listening facilitated by a professional instructor for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention in Study
Time Frame: 12 weeks
|
This outcome is the proportion of participants who completed post-test assessments and remained in the study.
|
12 weeks
|
|
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.
|
12 weeks
|
|
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).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Self-Regulation Questionnaire
Time Frame: 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.
|
Baseline and 12-weeks
|
|
Florida Cognitive Activities Scale
Time Frame: 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.
|
Baseline and 12-week
|
|
National Institutes of Health ToolBox Self-Efficacy
Time Frame: 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.
|
Baseline and 12-week
|
|
Short Grit Scale
Time Frame: 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.
|
Baseline and 12-week
|
|
Five Facets of Mindfulness
Time Frame: 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.
|
Baseline and 12-week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Julene Johnson, PhD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2022
Primary Completion (Actual)
June 28, 2023
Study Completion (Actual)
June 28, 2023
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
July 31, 2023
First Posted (Actual)
August 7, 2023
Study Record Updates
Last Update Posted (Estimated)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 1, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R61AG073669 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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