NCT05980286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

July 31, 2023

Results QC Date

June 6, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

AgingBrain AgingCognitionCognitive EngagementMild Cognitive ImpairmentMusicMusic-based InterventionMusic TrainingOlder Adults

Outcome Measures

Primary Outcomes (3)

  • Retention in Study

    This outcome is the proportion of participants who completed post-test assessments and remained in the study.

    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.

    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).

    12 weeks

Secondary Outcomes (5)

  • Short Self-Regulation Questionnaire

    Baseline and 12-weeks

  • Florida Cognitive Activities Scale

    Baseline and 12-week

  • National Institutes of Health ToolBox Self-Efficacy

    Baseline and 12-week

  • Short Grit Scale

    Baseline and 12-week

  • Five Facets of Mindfulness

    Baseline and 12-week

Study Arms (2)

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.

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.

Behavioral: Music Listening

Interventions

Piano Improvisation taught by a professional instructor for 12 weeks.

Piano Improvisation Training
Music ListeningBEHAVIORAL

Music Listening facilitated by a professional instructor for 12 weeks.

Music Listening Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Disability and Aging Services (DAS) Sites

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Julene Johnson, Professor
Organization
University of California, San Francisco

Study Officials

  • Julene Johnson, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: We will conduct a 2-arm randomized pilot trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

October 15, 2022

Primary Completion

June 28, 2023

Study Completion

June 28, 2023

Last Updated

December 17, 2025

Results First Posted

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations