Impact of Musical Improvisation Training on Cognitive Function in Older Adults

August 9, 2023 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

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, 94107
        • Potrero Hill Neighborhood House
      • San Francisco, California, United States, 94107
        • Third Baptist Church
      • San Francisco, California, United States, 94109
        • Aquatic Park Senior Center

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
  • 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 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
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 16 weeks.
Active Comparator: 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.
Music Listening facilitated by a professional instructor for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Self-Regulation Questionnaire
Time Frame: Baseline and 12-week Post Intervention
Self-report measure of the ability to regulate one's behavior in a goal-oriented way. This self-reported questionnaire contains 31 items, each item was scored on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The questionnaire scores ranged from 31 to 155, with higher scores indicating better self-regulation behavior.
Baseline and 12-week Post Intervention
Florida Cognitive Activities Scale
Time Frame: Baseline and 12-week Post Intervention
The Florida Cognitive Activities Scale is a 25-item scale (0-never to 5-daily) used to assess the cognitive activity in elderly populations. There are two subscales, the Higher Cognitive Abilities and Frequent Cognitive Abilities, and also a measure of self-reported maintenance of cognitive activity.
Baseline and 12-week Post Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short GRIT Scale
Time Frame: Baseline and 12-week Post Intervention
The Grist-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. Scores for each item range from 1 to 5, with overall scores being calculated by added up all points and dividing by 8. Higher scores indicate a higher level of "grit," or perseverance.
Baseline and 12-week Post Intervention
National Institutes of Health ToolBox Self-Efficacy
Time Frame: Baseline and 12-week Post Intervention
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). Higher scores indicate higher self-efficacy.
Baseline and 12-week Post Intervention
Five Facets of Mindfulness
Time Frame: Baseline and 12-week Post Intervention
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 6 (never to always true). Mindfulness and self-regulation ability have been identified as closely aligned in recent theoretical frameworks (e.g., the self- awareness, -regulation, and -transcendence model of mindfulness.
Baseline and 12-week Post Intervention
National Institutes of Health Toolbox Loneliness Scale
Time Frame: Baseline and 12-week Post Intervention
Self-report measure that assesses perceptions of loneliness and assesses the extent to which an individual feels alone or socially isolated from other individuals. The NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness using a 5-item fixed length form.
Baseline and 12-week Post Intervention
National Institutes of Health Toolbox Apathy
Time Frame: Baseline and 12-week Post Intervention
Instruments measuring deficits in-goal directed behavior and decrements in in-goal related thought content. It is 7 items, each item is scored on a 4-point Likert scale (not at all true to very true). The total score ranges from 18 to 72, with higher scores indicating more apathy.
Baseline and 12-week Post Intervention
Geriatric Depression Scale - Short Form
Time Frame: Baseline and 12-week Post Intervention
A short form comprising of 15-items, which is effective for the diagnosis of depression of elderly, is more simple, brief and time-effective.
Baseline and 12-week Post Intervention
10-item Personality Inventory
Time Frame: Baseline Only
Brief assessment of the Big Five Personality Dimensions: 1. Extraversion, 2. Agreeableness, 3. Conscientiousness, 4. Emotional Stability, and 5. Openness to Experience consisting of 10 items. Scores range from 1 (disagree strongly) to 7 (agree strongly).
Baseline Only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

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.

Clinical Trials on Cognitive Impairment

Clinical Trials on Piano Improvisation

3
Subscribe