Improv Music Therapy for Older Adults

February 20, 2026 updated by: University of California, San Francisco

Impact of Improvisation Music Therapy for Persons Living With Dementia and Their Care Partners

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Inclusion criteria for the Person Living with Dementia (PLWD) are:

  • 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)

Inclusion Criteria for Caregiver are:

  • Age 18 or Older
  • Moderate to good English fluency (self-rated English fluency)
  • Willing to participate in intervention with PLWD

Exclusion Criteria

Exclusion criteria for PLWD are:

  • 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

Exclusion criteria for Caregiver are:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Clinical Improvisation Immediately
Behavioral: Clinical Improvisation
Clinical improvisation music therapy offered as group sessions delivered by board-certified music therapist.
Experimental: Group B
Delayed Onset Clinical improvisation
Behavioral: Clinical Improvisation
Clinical improvisation music therapy offered as group sessions delivered by board-certified music therapist.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Science of Behavior Change (SOBC) Brief-COPE
Time Frame: Baseline and Post-Intervention, 8 weeks
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
Time Frame: Baseline and Post Intervention, 8 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dementia Mood Picture Test
Time Frame: Baseline and Post Intervention, 8 weeks
Participants are given large line face drawings with large font descriptors. Participants are asked whether or not they are experiencing each mood ("Are you in a good mood?") and the intensity of the mood. The test assesses the PLWD directly but focuses on six primary moods.
Baseline and Post Intervention, 8 weeks
SOBC Positive and Negative Affect (PANAS)
Time Frame: Baseline and Post Intervention, 8 weeks
The PANAS is a 20 item self-questionnaire. Respondent is asked to read several words which describe different feelings and emotions. Applicability of the emotion is scored by respondent on a 5 point Likert Scale (1 = very slightly or not at all to 5 = extremely). Higher scores on Positive Affect items incidate greater intensity of positive emotions and higher scores on Negative Affect indicate greater intensity of negative emotions.
Baseline and Post Intervention, 8 weeks
Neuropsychiatric Inventory (NPI-Q)
Time Frame: Baseline and Post Intervention, 8 weeks
The NPI-Q is a 12-item questionnaire completed by the caregiver. Each question asks about a neuropsychiatric symptom over the previous month. The Caregiver can say "no" and go on to the next question. If the Caregiver says "yes", the caregive then rates the a) Severity of the symptoms present on a 3 point scale (1=mild to 3 = severe), and b) Distress experienced by the caregiver due to that symptom on a 5 point scale (0 = not distressing at all to 5 very distressing).
Baseline and Post Intervention, 8 weeks
Kingston Caregivers STress Scale
Time Frame: Baseline and Post-Intervention, 8 weeks
The KCSS is at 10 item questionnaire completed by a family caregiver. The questions ask caregivers to report feeling of stress surrounding specific aspects of caregiving. Caregivers respond using a 5 point scale (1 = no stress to 5 = extreme stress)
Baseline and Post-Intervention, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen Barrett, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5K01AG088475-02 (U.S. NIH Grant/Contract)
  • 1K01AG088475-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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