RecruitingNot ApplicableNCT06605157

A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia

Pilot Randomized Clinical Trial of A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia (AMUSED)


Sponsor

Alaine E Hernandez, PhD

Enrollment

45 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria13

  • 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.
  • 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).

Exclusion Criteria4

  • 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.

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Interventions

BEHAVIORALAMUSED

Delivered live by a board-certified music therapist (MT-BC) 40 min 2x/week for 12 weeks (24 total sessions; 16 total hours) in small groups of 3-5 people. A Multimodal mUSic therapy intervention for Engaging persons with severe Dementia (AMUSED) uses live participant-preferred music and progressively layers singing, touch, and rhythmic instrument playing concurrent with participant behavioral responses. Follows the Clinical Practice Model for Persons with Dementia and implementation strategies that promote cognition, attention, familiarity, audibility, structure, autonomy per participants' strengths, interests, preferences, culture, and momentary responses. Each small group works with the same music therapist throughout the study.

BEHAVIORALReading Aloud

Delivered live by a trained research assistant ("interventionist") 40 min 2x/week for 12 weeks (24 total sessions; 16 total hours) in small groups of 3-5 people. The interventionist will read aloud from age-appropriate books (Chicken Soup for the Golden Soul by Jack Canfield; World of Wonders by Aimee Nezhukumatathil) selected to have sufficient material for all sessions, contain short stories to accommodate for attention span and session length, and offer choice. Follows implementation strategies identical to the music therapy arm (i.e., within the Clinical Practice Model for Persons with Dementia) that promote cognition, attention, familiarity, audibility, structure, autonomy per participants' strengths, interests, preferences, culture, and momentary responses. However, no music (including musical references) is used. Each small group works with the same reading interventionist throughout the study.


Locations(9)

Cedar Ridge Health Campus

Cynthiana, Kentucky, United States

Walker's Trail Senior Living

Danville, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Magnolia Springs Senior Living

Lexington, Kentucky, United States

Sayre Christian Village

Lexington, Kentucky, United States

The Homeplace at Midway

Midway, Kentucky, United States

Windsor Care Center

Mount Sterling, Kentucky, United States

Daisy Hill Senior Living

Versailles, Kentucky, United States

Thomson-Hood Veterans Center

Wilmore, Kentucky, United States

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