A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia
NCT ID: NCT06605157
Last Updated: 2026-01-20
Study Results
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Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-03-12
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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The overall objectives of this quantitative pilot study are to (i) establish a well-refined clinical trial design, procedures, and outcome measures and (ii) obtain preliminary data of enduring effectiveness of a multimodal music therapy intervention for engaging persons with severe dementia (AMUSED) with regards to behavioral symptoms and speech. AMUSED uses live participant-preferred music and progressively layers singing, touch, and rhythmic instrument playing concurrent with participant behavioral responses. This MBI is grounded in the person-centered Clinical Practice Model for PWD, which provides guidelines for adjusting the degree of support and challenge offered to an individual. This Model is also used to enhance treatment fidelity.
This pilot study builds on a feasibility study that field tested logistics and demonstrated feasibility and acceptability of the AMUSED intervention protocol through a randomized cross-over trial design. The researchers refined recruitment, data collection, protocol training, and intervention processes. As in past similar work, the researchers demonstrated positive engagement during music therapy sessions. However, obtaining longer-term measures of treatment effects (i.e., neuropsychiatric inventory, Fitbit actigraphy, pulse oximetry, functional measures) proved impractical and unreliable in the care milieu. The researchers' recent qualitative work with long-term care staff revealed possible solutions to more feasibly measure such outcomes in a long-term care setting. The current pilot study builds on this past feasibility and qualitative work.
In this quantitative pilot study, the investigators will use a randomized clinical trial design to test methods and procedures that will be used in a future larger clinical trial. This will help enhance the rigor and reproducibility of this research. The aims of this pilot study are to: 1) determine whether the clinical trial protocol is feasible for a full-scale trial, 2) select the most appropriate primary outcome measure(s) of behavioral symptoms of dementia, and 3) determine if spontaneous speech offers a useful indicator of music-based intervention effectiveness in persons with severe dementia. Participants will be older adults with severe dementia who live in a long-term care facility. To isolate the effects of the music and obtain an estimate of cluster effects, care facilities will be randomly assigned to either receive music therapy or reading. Both conditions use the same structure, strategies, and dosage, with music being the key difference.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Music Therapy
Live delivery of a music therapy protocol that is designed to be led by a board-certified music therapist (MT-BC). Activity blocks are identical to the reading arm:
* T0 Baseline measures
* Weeks 1-4: music therapy intervention
* T1 measures (end of week 4)
* Weeks 5-8: music therapy intervention
* T2 measures (end of week 8)
* Weeks 5-8: music therapy intervention
* T3 measures (end of week 12)
* T4 measures 4-week-follow-up (week 16)
AMUSED
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.
Reading Aloud
Live reading aloud of an age-appropriate book by a group leader to control for social attention and isolate the effects of music.
Activity blocks are identical to the music therapy arm:
* T0 Baseline measures
* Weeks 1-4: music therapy intervention
* T1 measures (end of week 4)
* Weeks 5-8: music therapy intervention
* T2 measures (end of week 8)
* Weeks 5-8: music therapy intervention
* T3 measures (end of week 12)
* T4 measures 4-week-follow-up (week 16)
Reading 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.
Interventions
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AMUSED
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.
Reading 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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Alaine E Hernandez, PhD
OTHER
Responsible Party
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Alaine E Hernandez, PhD
Assistant Professor of Music Therapy
Principal Investigators
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Alaine E. Reschke-Hernandez, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Reschke-Hernández, A. E. (2021). The Clinical Practice Model for Persons with Dementia: Application to music therapy. Music Therapy Perspectives, 39(2), 133-141. https://doi.org/10.1093/mtp/miab006
Weinfurt KP. Clarifying the Meaning of Clinically Meaningful Benefit in Clinical Research: Noticeable Change vs Valuable Change. JAMA. 2019 Dec 24;322(24):2381-2382. doi: 10.1001/jama.2019.18496. No abstract available.
van der Steen JT, Smaling HJ, van der Wouden JC, Bruinsma MS, Scholten RJ, Vink AC. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2018 Jul 23;7(7):CD003477. doi: 10.1002/14651858.CD003477.pub4.
Reschke-Hernandez AE, Tranel D. Strategies to enhance treatment fidelity and music-based intervention reporting in dementia research. Transl Behav Med. 2024 May 24;14(6):353-358. doi: 10.1093/tbm/ibae003.
Reschke-Hernandez, A.E., Ross, M., Davis, H.R., Latham, E.F. and Veblen, N.B. (2023), Multimodal music therapy intervention for engagement and agitation reduction for persons with severe dementia: Study protocol of a pilot randomized cross-over trial. Alzheimer's Dement., 19: e080171. https://doi.org/10.1002/alz.080171
Reschke-Hernandez AE, Gfeller K, Oleson J, Tranel D. Music Therapy Increases Social and Emotional Well-Being in Persons With Dementia: A Randomized Clinical Crossover Trial Comparing Singing to Verbal Discussion. J Music Ther. 2023 Oct 7;60(3):314-342. doi: 10.1093/jmt/thad015.
Reschke-Hernández, A. E. (2019). A clinical practice model of music therapy to address psychosocial functioning for persons with dementia: Model development and randomized clinical crossover trial (NCT03643003). Doctoral dissertation, University of Iowa. https://doi.org/10.17077/etd.59oh-y06y
Profyri E, Leung P, Huntley J, Orgeta V. Effectiveness of treatments for people living with severe dementia: A systematic review and meta-analysis of randomised controlled clinical trials. Ageing Res Rev. 2022 Dec;82:101758. doi: 10.1016/j.arr.2022.101758. Epub 2022 Oct 13.
Edwards E, St Hillaire-Clarke C, Frankowski DW, Finkelstein R, Cheever T, Chen WG, Onken L, Poremba A, Riddle R, Schloesser D, Burgdorf CE, Wells N, Fleming R, Collins FS. NIH Music-Based Intervention Toolkit: Music-Based Interventions for Brain Disorders of Aging. Neurology. 2023 May 2;100(18):868-878. doi: 10.1212/WNL.0000000000206797. Epub 2023 Jan 13.
Kistin C, Silverstein M. Pilot Studies: A Critical but Potentially Misused Component of Interventional Research. JAMA. 2015 Oct 20;314(15):1561-2. doi: 10.1001/jama.2015.10962. No abstract available.
Other Identifiers
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94750
Identifier Type: -
Identifier Source: org_study_id
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