NCT06605157 · ACTIVE NOT RECRUITING
A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia
This pilot trial is testing whether a structured music therapy program called AMUSED, which includes live music, singing, and rhythm instruments, reduces behavioral symptoms and improves engagement in people with severe dementia living in care facilities. It compares music therapy to a group reading activity over 12 weeks. This is a feasibility pilot, meaning researchers are figuring out whether a larger, definitive trial is even practical to run.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-19