NCT06721390

Brief Summary

This project will study 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

75
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress97%
Mar 2024May 2026

Study Start

First participant enrolled

March 5, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

December 3, 2024

Last Update Submit

March 9, 2026

Conditions

Keywords

AgingBrain AgingCognitionCognitive EngagementMild Cognitive ImpairmentMusicMusic-based InterventionMusic TrainingOlder Adults

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline and 12-week Post Intervention

  • Short Self Regulatory 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

    Baseline and 12-week Post Intervention

Secondary Outcomes (7)

  • National Institutes of Health ToolBox Self-Efficacy

    Baseline and 12-week Post Intervention

  • Short GRIT Scale

    Baseline and 12-week Post Intervention

  • Five Facets of Mindfulness

    Baseline and 12-week Post Intervention

  • National Institutes of Health Toolbox Loneliness Scale

    Baseline and 12-week Post Intervention

  • National Institutes of Health Toolbox Apathy

    Baseline and 12-week Post Intervention

  • +2 more secondary outcomes

Study Arms (2)

Piano Improvisation

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

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
Music ListeningBEHAVIORAL

Music Listening facilitated by a professional instructor for 12 weeks.

Music Listening

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
  • 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 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)

The study is taking place at community sites in San Francisco.

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Julene Johnson, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

March 5, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations