RECRUITING

A Multimodal Music Therapy Intervention for Engaging Persons with Severe Dementia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06605157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 65 years or older
  2. * late-onset dementia diagnosis from a physician
  3. * stable at facility long enough to establish residency and routine at the facility (about 2 months prior to start of study)
  4. * English is primary language (for pilot study practicality and ensure straightforward evaluation of our aims)
  5. * 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.
  1. * music therapy recipient
  2. * co-occurring movement disorder
  3. * preexisting cognitive disability
  4. * 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.

Contacts and Locations

Study Contact

Alaine E. Reschke-Hernandez, PhD
CONTACT
859-257-4536
Alaine.ReschkeHernandez@uky.edu

Principal Investigator

Alaine E. Reschke-Hernandez, PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40506
United States
Windsor Care Center
Mt. Sterling, Kentucky, 40353
United States

Collaborators and Investigators

Sponsor: Alaine E Hernandez, PhD

  • Alaine E. Reschke-Hernandez, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Dementia Severe