Music therapy to engage people with severe dementia
Pilot Randomized Clinical Trial of A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia (AMUSED)
This study is testing if music therapy can help older adults with severe dementia feel more engaged and reduce challenging behaviors while they live in care facilities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 9 sites (Cynthiana, Kentucky and 8 other locations) |
| Trial ID | NCT06605157 on ClinicalTrials.gov |
What this trial studies
This pilot randomized clinical trial aims to evaluate the effectiveness of a music therapy intervention called AMUSED in improving engagement and reducing behavioral symptoms in older adults with severe dementia residing in care facilities. Participants will be assigned to either group-based music therapy sessions, which include live music and singing, or a reading activity focused on storytelling and memory sharing. The study will assess the feasibility of conducting a larger trial, identify appropriate outcome measures, and explore the impact of music therapy on behavioral symptoms and speech patterns. Sessions will occur twice a week for 12 weeks, each lasting 40 minutes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with a late-onset diagnosis of severe dementia who reside in care facilities.
Not a fit: Patients who are currently receiving music therapy or have co-occurring movement disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the quality of life for patients with severe dementia by improving their engagement and reducing behavioral symptoms.
How similar studies have performed: While empirical evidence for music-based interventions in severe dementia is limited, similar approaches have shown promise in enhancing engagement and reducing symptoms in other populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cynthiana, Kentucky and 8 other locations
- Cedar Ridge Health Campus — Cynthiana, Kentucky, United States (Completed)
- Walker's Trail Senior Living — Danville, Kentucky, United States (Completed)
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
- Magnolia Springs Senior Living — Lexington, Kentucky, United States (Withdrawn)
- Sayre Christian Village — Lexington, Kentucky, United States (Active_not_recruiting)
- The Homeplace at Midway — Midway, Kentucky, United States (Completed)
- Windsor Care Center — Mount Sterling, Kentucky, United States (Withdrawn)
- Daisy Hill Senior Living — Versailles, Kentucky, United States (Active_not_recruiting)
- Thomson-Hood Veterans Center — Wilmore, Kentucky, United States (Completed)
Study contacts
- Principal investigator: Alaine E. Reschke-Hernandez, PhD — University of Kentucky
- Study coordinator: Alaine E. Reschke-Hernandez, PhD
- Email: Alaine.ReschkeHernandez@uky.edu
- Phone: 859-257-4536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.