A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia

NCT06605157 | Recruiting

• 2 other identifiers: 94750P30AG072946
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Dementia Severe

Keywords

Music Therapy; Evidence-based practice; Behavioral symptoms; Speech; Language; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in Dementia Behavior at 12 Weeks

  The Quick Dementia Behavior Observation Scale (QD-BOS) is an 18-item observational measure (est. 3 min. to complete). Section 1 contains the 11 sub-questions from the Neuropsychiatric Inventory-Nursing Home section C "agitation/aggression" and care staff rate the presence or absence of 8 behaviors in the past week (raw score 0-8), the frequency (raw score 1-4) and severity of behaviors (raw score 1-3), total score (frequency x severity, ranges 1-12), and occupational disruptiveness of those behaviors (raw score 0-5; all ranges higher score indicates worse behavior). Section 2 contains 5 questions regarding observed psychosocial well-being in the past week using a 5-point Likert-type scale (item range 1-5), and an optional open-ended item. Section 3 contains 1 question regarding job-related stress in the past week, using a 5-point Likert-type scale (range 1-5). A lower score indicates worse/less desirable behavior. Completed by care staff at baseline and every 4 weeks.

  Baseline, end of Week 12

Secondary Outcomes (6)

• Mean Change from Baseline in Dementia Behavior at 4 Weeks

  Baseline, end of Week 4

• Mean Change from Baseline in Dementia Behavior at 8 Weeks

  Baseline, end of Week 8

• Mean Change from Baseline in Dementia Behavior at 4-Week Follow-Up (16 Weeks)

  Baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)

• Mean Change from Baseline in Language Function at 12 Weeks

  Enrollment, end of Week 12

• Mean Change from Baseline in Cognition at 12 Weeks

  Enrollment, end of Week 12

Other Outcomes (3)

• Mean Change in Spontaneous Speech at Week 4

  Immediately before and immediately after session 8 at week 4

• Mean Change in Spontaneous Speech at Week 8

  Immediately before and immediately after session 16 at week 8

• Mean Change in Spontaneous Speech at Week 12

  Immediately before and immediately after session 24 at week 12

Study Arms (2)

Music Therapy

EXPERIMENTAL

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)

Behavioral: AMUSED

Reading Aloud

ACTIVE COMPARATOR

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)

Behavioral: Reading Aloud

Interventions

AMUSED BEHAVIORAL

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.

Music Therapy

Reading Aloud BEHAVIORAL

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.

Reading Aloud

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Alaine E Hernandez, PhD: lead
• National Institute on Aging (NIA): collaborator

Study Sites (9)

Cedar Ridge Health Campus

Cynthiana, Kentucky, 41031, United States

COMPLETED

Walker's Trail Senior Living

Danville, Kentucky, 40422, United States

COMPLETED

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Magnolia Springs Senior Living

Lexington, Kentucky, 40511, United States

WITHDRAWN

Sayre Christian Village

Lexington, Kentucky, 40517, United States

ACTIVE NOT RECRUITING

The Homeplace at Midway

Midway, Kentucky, 40347, United States

COMPLETED

Windsor Care Center

Mount Sterling, Kentucky, 40353, United States

WITHDRAWN

Daisy Hill Senior Living

Versailles, Kentucky, 40383, United States

ACTIVE NOT RECRUITING

Thomson-Hood Veterans Center

Wilmore, Kentucky, 40390, United States

COMPLETED

Related Publications (10)

• 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.

  PMID: 31790549 BACKGROUND

• 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.

  PMID: 30033623 BACKGROUND

• 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.

  PMID: 38334197 BACKGROUND

• 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&#39;s Dement., 19: e080171. https://doi.org/10.1002/alz.080171

  BACKGROUND

• 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.

  PMID: 37220880 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 36243355 BACKGROUND

• 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.

  PMID: 36639235 BACKGROUND

• 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.

  PMID: 26501530 BACKGROUND

MeSH Terms

Conditions

Behavioral Symptoms; Speech; Language

Condition Hierarchy (Ancestors)

Behavior; Verbal Behavior; Communication

Study Officials

• Alaine E. Reschke-Hernandez, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaine E. Reschke-Hernandez, PhD

CONTACT

859-257-4536; Alaine.ReschkeHernandez@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants and care providers (music therapists, reading group leaders) will not be masked; both will know what is being received (music therapy or reading). Principal investigator Reschke-Hernandez and Co-Is Schmitt and Abner will remain masked to allocation. Care staff who collect behavior data will not be masked; care staff will know if the facility is receiving music therapy or reading. However, for all other outcomes, research assistants who assess participants will be masked to group assignment without knowledge of the intervention assigned to individual participants. Allocation and assignment information will be kept in a separate secure document that is not accessible to the PI or Co-Is.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Music Therapy

Model Details: To prevent cross-contamination, a research team member will randomize facilities as clusters (N=8) 1:1 to either the music or the reading intervention using a random number table. Opting for four clusters per arm will enable the researchers to estimate cluster effects and evaluate delivery across different care structures. The researchers will enroll at least 5 participants from each cluster/facility to provide a buffer against attrition to maintain a group of at least 3 individuals in each cluster. Delivery of both music and reading is in small groups (3-5 people).

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 20, 2024
• Study Start: March 12, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication. The principal investigator will consider sharing data and study materials prior to that time frame in consultation with the study team.
• Access Criteria: The principal investigator will share data, qualitative and quantitative analysis plans, and study materials with other researchers who provide a reasonable rationale for intended use, by email. Requests will be reviewed by the principal investigator Reschke-Hernandez, all co-investigators, and all study team members.

Locations

US (9)