NCT07419022

Brief Summary

Older adults and their care partners will participate in music therapy sessions for approximately 8 weeks. Before and after the 8 week study period, participants will fill out questionnaires about their mood, stress levels, and emotions. During the music therapy sessions, they may be observed or asked questions about the music therapy sessions.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Dec 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 11, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

musicimprovisationperson living with dementiacaregiverAlzheimer's Disease and related diseasesmechanism of behavior changestress reductionbehavior change

Outcome Measures

Primary Outcomes (2)

  • Science of Behavior Change (SOBC) Brief-COPE

    The Brief COPE is a 28 item measure of strategies used for coping or regulating cognitions in response to stressors. The questions assess the frequency with which a person uses different coping strategies (e.g. "I've been turning to work or other activities to take my mind off strings") and the respondent gives a rating on a 5 item scale (1= I haven't been doing this at all to 4 I've been doing this a lot).

    Baseline and Post-Intervention, 8 weeks

  • SOBC Perceived Stress Scale

    The Perceived Stress Scale ask participants about their feelings and thoughts during the last month. There are 10 items and participants are asked how often they felt orr thought a certian way (0 = never to 4 very often)

    Baseline and Post Intervention, 8 weeks

Secondary Outcomes (4)

  • Dementia Mood Picture Test

    Baseline and Post Intervention, 8 weeks

  • SOBC Positive and Negative Affect (PANAS)

    Baseline and Post Intervention, 8 weeks

  • Neuropsychiatric Inventory (NPI-Q)

    Baseline and Post Intervention, 8 weeks

  • Kingston Caregivers STress Scale

    Baseline and Post-Intervention, 8 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Clinical Improvisation Immediately

Behavioral: Clinical Improvisation

Group B

EXPERIMENTAL

Delayed Onset Clinical improvisation

Behavioral: Clinical Improvisation

Interventions

Clinical improvisation music therapy offered as group sessions delivered by board-certified music therapist.

Group AGroup B

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
  • Medical diagnosis of Alzheimer's Disease
  • Mild dementia defined as MoCA score between 16-20, or MMSE score between 19-24
  • Sufficient visual and hearing acuity (age-related to normal hearing loss with assistive devices)
  • English fluency rated fairly well to well (self-rated English fluency)
  • Age 18 or Older
  • Moderate to good English fluency (self-rated English fluency)
  • Willing to participate in intervention with PLWD

You may not qualify if:

  • Medical diagnosis of severe dementia (any etiology)
  • Non-AD dementia diagnosis (e.g., frontotemporal dementia)
  • Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study
  • Significant difficulty moving the hands or arms (severe arthritis, neuropathy)
  • Plans to move out of the area within six months
  • Current but not prior severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
  • Serious medical condition (e.g., an end-stage disease requiring hospice, aphasia from stroke, paralysis, brain injury) requiring active medical management that would interfere with participation in the study
  • Plans to move out of the area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Karen Barrett, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen C Barrett, PhD

CONTACT

Howie Rosen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: This is a waitlisted control pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations