Pilot Randomized Clinical Trial of A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia (AMUSED)
Trial ID: NCT06605157
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-03-12
Completion date: 2026-06-30
Sponsor: Alaine E Hernandez, PhD
Collaborators: National Institute on Aging (NIA)
Conditions: Dementia Severe
Interventions: AMUSED; Reading Aloud
Locations: Cedar Ridge Health Campus; Walker's Trail Senior Living; University of Kentucky; Magnolia Springs Senior Living; Sayre Christian Village; The Homeplace at Midway; Windsor Care Center; Daisy Hill Senior Living; Thomson-Hood Veterans Center
Countries: United States; United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 45
Age range: 65 Years - None
Sex: ALL

Summary:
The goal of this pilot randomized clinical trial is to learn if a music therapy treatment, called AMUSED, can improve engagement and reduce behavioral symptoms in older adults with severe dementia who live in care facilities. The main questions it aims to answer are:

* Is it feasible to conduct a full-scale trial of AMUSED?
* Can investigators identify the best outcome measures to assess impact on behavioral symptoms of dementia?
* Does speech offer a useful indicator of treatment effectiveness? Researchers will compare a group-based music therapy treatment to a reading activity to learn if music therapy leads to greater improvements in behavioral symptoms and speech patterns.

Participants will:

* Participate in either music therapy (includes live music, singing, and rhythmic instrument playing) or a reading group with stories about life and nature and talk about memories.
* Attend small group sessions twice a week for 12 weeks, with each session lasting 40 minutes between lunch and dinner.
* Be observed and assessed for behavioral symptoms, cognition, and speech several times during treatment and at a 4-week follow-up.

Eligibility criteria:
PARTICIPANT Inclusion Criteria:

* 65 years or older
* late-onset dementia diagnosis from a physician
* stable at facility long enough to establish residency and routine at the facility (about 2 months prior to start of study)
* English is primary language (for pilot study practicality and ensure straightforward evaluation of our aims)
* Dementia is severe: As in the feasibility study, residents' charted score on the Brief Inventory of Mental Status (BIMS) \< 7 will be used and no independent function in community affairs, hobbies, chores, or personal care. The BIMS is a component of the Minimum Data Set (MDS), a federally mandated clinical assessment for all residents in US Medicare and Medicaid certified care facilities. It is completed periodically and interpreted by a licensed health care professional employed by the facility who has completed requisite training on the assessment.

PARTICIPANT Exclusion criteria:

* music therapy recipient
* co-occurring movement disorder
* preexisting cognitive disability
* Milder dementia (BIMS 7+); Persons with more significant cognitive decline could arguably respond differently to the intervention than those with milder dementia, a notion that is supported by past music therapy research with this population.

FACILITIES - Inclusion Criteria:

* Any facility in Kentucky that provides residential care for persons with severe dementia (up to 8 facilities).
* At least 5 residents must enroll to make the best use of our resources.
* At least 1 facility staff member available to help with recruitment and periodic observable data collection
* Can accommodate consistent session days and times between lunch and dinner, 2 times per week for 40 minutes, for 12 weeks.
* Willing to communicate questions, concerns, and changes in safety protocols to the research team.
* Can provide a space appropriate for a small group activity (3-5 residents plus a group leader).
* Can ensure staff support is available for safely transitioning participants to/from sessions at the agreed upon session days and time.
* Can assert that music therapy from a credentialed music therapist (MT-BC) is not offered by the facility, to prevent "double dosing" (music entertainment is ok).

FACILITIES - Exclusion Criteria:

-Does not meet one or more inclusion criteria.

Outcomes:
Mean Change from Baseline in Dementia Behavior at 12 Weeks