Music for the Mind Study
M4M
Feasibility and Acceptability of Music Training Programs Among Older Adults Living With Mild Cognitive Impairment: a Pilot Randomized Controlled Trial
1 other identifier
interventional
19
1 country
1
Brief Summary
The goal of this pilot clinical trial is to learn if older adults with mild cognitive impairment (MCI) find two music programs equally acceptable. This pilot study will help researchers prepare for a future, large-scale clinical trial to learn if music training can slow cognitive decline and promote emotional well-being in those at risk for Alzheimer's disease and related dementias. The main questions this pilot study aims to answer are:
- Do participants like the music programs?
- Do participants stay enrolled in the study?
- Do participants report perceived benefits of the programs for their emotional well-being or everyday memory? Participants will:
- Participate in 12-weekly sessions of piano lessons or music lessons, with group and individual lessons alternating each week.
- Have home practice in between lessons, with a keyboard or other instruments provided.
- Keep a diary of their home practice and their mood before and after practice.
- Participate in interviews before and after the 12-week programs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2025
CompletedFirst Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedApril 8, 2026
March 1, 2025
7 months
March 4, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of participants who complete the 12-week program they are randomly assigned to
The proportion of participants who complete the program. Feasibility of retention is defined as \> 80% of enrolled participants in each group complete at least 10 lesson sessions.
From enrollment to the end of the program at 12 weeks
Secondary Outcomes (2)
Expectancy of the 12-week program they are randomly assigned to
At enrollment
Percent of participants who are approached and consent to the study
At enrollment
Other Outcomes (2)
Acceptability of the 12-week program they are randomly assigned to
At enrollment, at the end of the program at 12 weeks
Satisfaction of the 12-week program they are randomly assigned to
At the end of the program at 12 weeks
Study Arms (2)
Piano lessons
EXPERIMENTALIntroduction to piano playing, including instruction and practice in note reading, finger positions, and song playing.
Music lessons
ACTIVE COMPARATORIntroduction to varied instrument playing, music singing, and music appreciation.
Interventions
The program consists of 12-weekly piano lessons, alternating small group lessons and individual lessons each week. Individual lessons reinforce and help personalize what is instructed during group lessons. Lessons are tailored to help older adults with memory challenges learn note reading, finger positioning, and song playing. Participants are asked to practice at home in between lessons for 10 minutes per day, 5 times per week, with a keyboard and bench provided.
The program consists of 12-weekly music lessons, alternating small group lessons and individual lessons each week. Individual lessons reinforce and help personalize what is instructed during group lessons. Lessons are tailored to help older adults with memory challenges learn various instruments, engage in group playing during group lessons, and engage in music appreciation activities. Participants are asked to practice at home in between lessons for 10 minutes per day, 5 times per week, with instruments provided.
Eligibility Criteria
You may qualify if:
- Aged ≥ 60 years
- English-speaking
- Community-dwelling
- Medical diagnosis of MCI by a physician or research diagnostic criteria for MCI, defined by having Montreal Cognitive Assessment (MoCA), with a cutoff of 20- 25 (further adjusted for racial/ethnic differences)
- Capable to consent as identified by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- No severe psychiatric condition (e.g., bipolar disorder)
You may not qualify if:
- Demonstrate musicality knowledge, as assessed by the Musicality Assessment developed by the study team
- Currently participating in a formal music activity (performance, classes, lessons, etc.)
- Major impairment in eyesight or hearing that precludes music reading, hearing, or engagement in the class
- Any difficulty using a keyboard (portable electric piano) due to pain, neuropathy, tremor, or upper finger/hand/limb injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Eastman Performing Arts Medicine Centercollaborator
- University of Rochester Aging Institutecollaborator
- University of Rochester School of Nursingcollaborator
Study Sites (1)
School of Nursing
Rochester, New York, 14620, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 10, 2025
Study Start
February 24, 2025
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
April 8, 2026
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share