NCT07069530

Brief Summary

This single-site interventional study evaluated the effects of receptive live music therapy on depression in patients with dementia and caregiver burden at the AMAVIDA Memory Care Unit in Fort Myers, Florida. Over two weeks, participants attended six 30-minute live piano performances using a fixed setlist delivered one hour before dinner. Pre- and post-intervention assessments included the Geriatric Depression Scale (GDS) for patients and the Caregiver Burden Scale in End-of-Life Care (CBS-EOLC) for staff caregivers. Data were analyzed using paired-sample t-tests to compare depression and burden scores before and after the music intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 7, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Music TherapyDementiaDepressionAlzheimer's DiseaseCaregiver BurdenReceptive Music Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Geriatric Depression Scale (GDS) Score Among Residents

    The Geriatric Depression Scale (Short Form, 15 items) was administered to residents diagnosed with dementia before and after a two-week receptive music therapy intervention. Scores range from 0 to 15, with higher scores indicating greater depressive symptoms. The primary outcome is the change in GDS score from pre- to post-intervention.

    Within 2 weeks (pre- and post-intervention)

Secondary Outcomes (1)

  • Change in Caregiver Burden Scale in End-of-Life Care (CBS-EOLC) Score

    Within 2 weeks (pre- and post-intervention)

Study Arms (1)

Music Therapy Intervention Arm

EXPERIMENTAL

Participants in this arm received six 30-minute sessions of receptive live music therapy delivered via solo piano performance over the course of two weeks. Sessions were held in a communal setting one hour before dinner, using a fixed playlist to ensure consistency. Pre- and post-intervention measures included the Geriatric Depression Scale (GDS) for residents and the Caregiver Burden Scale in End-of-Life Care (CBS-EOLC) for staff.

Behavioral: Receptive Music Therapy

Interventions

Participants received six 30-minute sessions of receptive music therapy delivered by live solo piano performance over two weeks. The same playlist was performed in a fixed order at each session, held one hour before dinner. The intervention was designed to reduce depressive symptoms in dementia patients and alleviate caregiver burden using a structured, low-cost, non-pharmacological approach.

Music Therapy Intervention Arm

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident participants must be aged 60 or older.
  • Residents must have a documented diagnosis of Alzheimer's disease or related dementia.
  • Residents must have completed a Mini-Mental State Examination (MMSE) with a score of ≥17.
  • Caregiver participants must be aged 25 or older.
  • Caregivers must have at least one year of experience working in the memory care unit.

You may not qualify if:

  • Residents with MMSE scores \<17 indicating severe cognitive impairment.
  • Residents unable to provide coherent verbal responses.
  • Participants (residents or caregivers) who decline to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amavida Assisted Living

Fort Myers, Florida, 33907, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer DiseaseCognitive DysfunctionDepressionCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesCognition DisordersBehavioral SymptomsBehaviorStress, Psychological

Study Officials

  • Hieu D Nguyen, Associates Degree

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

February 1, 2022

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of the study population, which includes cognitively impaired older adults. The data collected, including EEG readings and behavioral assessments, may pose a risk of re-identification even after de-identification procedures. Furthermore, participants and/or their legal guardians did not provide consent for their data to be shared with external researchers. The study was designed for internal use only and not intended for secondary analysis or broader data dissemination.

Locations