AgingNCT05980286
Impact of Music Improvisation Training on Cognitive Function in Older Adults
A study testing Piano Improvisation and Music Listening in people with Aging and Cognitive Aging, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Aging, Cognitive Impairment
- What is being tested?
- Piano Improvisation and Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Disability and Aging Services (DAS) Sites
San Francisco, California, 94103
About this study
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.
Read the 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.
- Conditions
- Aging, Cognitive Aging, Cognitive Impairment, Cognitive Training, Cognitively Normal Older Adults, Mild Cognitive Impairment
- Being tested
- Piano Improvisation, Music Listening
- Keywords
- Aging, Brain Aging, Cognition, Cognitive Engagement, Mild Cognitive Impairment, Music, Music-based Intervention, Music Training, Older Adults
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piano ImprovisationBehavioural
Piano Improvisation taught by a professional instructor for 12 weeks.
Music ListeningBehavioural
Music Listening facilitated by a professional instructor for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Piano Improvisation |
| 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. Receives: Behavioral: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Study
This outcome is the proportion of participants who completed post-test assessments and remained in the study.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start15 Oct 2022
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a 2-arm randomized pilot trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Julene Johnson, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980286
- Sponsor's protocol ID
- 1R61AG073669
- Other IDs
- 1R61AG073669
- Status last verified
- Dec 2025
- First submitted
- 31 Jul 2023
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Music Improvisation Training on Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT05980286
- Acronym / sponsor ID
- 1R61AG073669
- Conditions
- Aging, Cognitive Aging, Cognitive Impairment, Cognitive Training, Cognitively Normal Older Adults, Mild Cognitive Impairment
- Keywords
- Aging, Brain Aging, Cognition, Cognitive Engagement, Mild Cognitive Impairment, Music, Music-based Intervention, Music Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will conduct a 2-arm randomized pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Piano Improvisation Training | Experimental | Behavioral: Piano ImprovisationThis 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. |
| Music Listening Training | Active comparator | Behavioral: Music ListeningThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piano ImprovisationPiano Improvisation taught by a professional instructor for 12 weeks. | Behavioural | Piano Improvisation Training |
| Music ListeningMusic Listening facilitated by a professional instructor for 12 weeks. | Behavioural | Music Listening Training |
Primary outcome
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).
5 secondary outcomes
Short Self-Regulation Questionnaire
Time frame: Baseline and 12-weeks
Florida Cognitive Activities Scale
Time frame: Baseline and 12-week
National Institutes of Health ToolBox Self-Efficacy
Time frame: Baseline and 12-week
Short Grit Scale
Time frame: Baseline and 12-week
Five Facets of Mindfulness
Time frame: Baseline and 12-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julene Johnson, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piano Improvisation and Music Listening in people with Aging and Cognitive Aging, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in Study (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.