Improv Music Therapy for Older Adults

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: Not yet recruiting
• Conditions: Alzheimer's Disease (AD); Older Adults (65 Years and Older)
• Intervention / Treatment: Behavioral: Clinical Improvisation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen C Barrett, PhD; Phone Number: 4153534501; Email: Karen.Barrett@ucsf.edu
• Study Contact Backup: Name: Howie Rosen, MD; Phone Number: ]415 476-5567; Email: howie.rosen@ucsf.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dementia Mood Picture Test	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)	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)	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	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

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Karen Barrett, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stress reduction; music; caregiver; behavior change; improvisation; person living with dementia; Alzheimer's Disease and related diseases; mechanism of behavior change
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID 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