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Impact of Musical Improvisation Training on Cognitive Function in Older Adults

Primary Purpose

Aging, Cognitive Aging, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Piano Improvisation
Music Listening
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aging focused on measuring Aging, Brain Aging, Cognition, Cognitive Engagement, Mild Cognitive Impairment, Music, Music-based Intervention, Music Training, Older Adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Potrero Hill Neighborhood House
  • Third Baptist Church
  • Aquatic Park Senior Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Piano Improvisation

Music Listening

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Short Self-Regulation Questionnaire
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.
Florida Cognitive Activities Scale
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.

Secondary Outcome Measures

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). Higher scores indicate higher self-efficacy.
Short GRIT Scale
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.
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 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.
National Institutes of Health Toolbox Loneliness Scale
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.
National Institutes of Health Toolbox Apathy
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.
Geriatric Depression Scale - Short Form
A short form comprising of 15-items, which is effective for the diagnosis of depression of elderly, is more simple, brief and time-effective.
10-item Personality Inventory
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).

Full Information

First Posted
July 31, 2023
Last Updated
August 9, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05980286
Brief Title
Impact of Musical Improvisation Training on Cognitive Function in Older Adults
Official Title
Impact of Musical Improvisation Training on Cognitive Function in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
June 28, 2023 (Actual)
Study Completion Date
June 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Older Adults

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will conduct a 2-arm randomized pilot trial.
Masking
Investigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Piano Improvisation
Arm Type
Experimental
Arm Description
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.
Arm Title
Music Listening
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Piano Improvisation
Intervention Description
Piano Improvisation taught by a professional instructor for 16 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Music Listening
Intervention Description
Music Listening facilitated by a professional instructor for 16 weeks.
Primary Outcome Measure Information:
Title
Short Self-Regulation Questionnaire
Description
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.
Time Frame
Baseline and 12-week Post Intervention
Title
Florida Cognitive Activities Scale
Description
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.
Time Frame
Baseline and 12-week Post Intervention
Secondary Outcome Measure Information:
Title
National Institutes of Health ToolBox Self-Efficacy
Description
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.
Time Frame
Baseline and 12-week Post Intervention
Title
Short GRIT Scale
Description
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.
Time Frame
Baseline and 12-week Post Intervention
Title
Five Facets of Mindfulness
Description
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.
Time Frame
Baseline and 12-week Post Intervention
Title
National Institutes of Health Toolbox Loneliness Scale
Description
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.
Time Frame
Baseline and 12-week Post Intervention
Title
National Institutes of Health Toolbox Apathy
Description
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.
Time Frame
Baseline and 12-week Post Intervention
Title
Geriatric Depression Scale - Short Form
Description
A short form comprising of 15-items, which is effective for the diagnosis of depression of elderly, is more simple, brief and time-effective.
Time Frame
Baseline and 12-week Post Intervention
Title
10-item Personality Inventory
Description
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).
Time Frame
Baseline Only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julene Johnson, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Potrero Hill Neighborhood House
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Third Baptist Church
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Aquatic Park Senior Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Musical Improvisation Training on Cognitive Function in Older Adults

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