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NCT Number: NCT07069530

Impact of Musical Therapeutic Intervention on Depression in Dementia Patients and Caregiver Burden

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.

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Key information

Conditions

Dementia Alzheimer Disease Alzheimer Disease (AD) Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Caregiver Burden of People With Dementia Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairments Depression Depression Chronic Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stress, Psychological Tauopathies

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amavida Assisted Living

Fort Myers, Florida, 33907, United States

About this study

This exploratory study was designed to assess the feasibility and therapeutic potential of receptive live music as a non-pharmacological intervention for older adults with dementia and their caregivers in a residential memory care setting. The intervention involved structured, live piano performances using a fixed repertoire and delivery schedule to maintain consistency across sessions. Participants were recruited from a licensed memory care unit within a retirement community at Amavida in Fort Myers Florida and included both residents diagnosed with Alzheimer's disease or related dementias and their long-term caregivers.

Eligible residents underwent cognitive screening using the Mini-Mental State Examination (MMSE) to ensure the ability to engage meaningfully with the intervention. Pre- and post-intervention assessments focused on psychological well-being, specifically depression and caregiver burden. Validated scales-the 15-item Geriatric Depression Scale (GDS) and the Caregiver Burden Scale in End-of-Life Care (CBS-EOLC)-were administered to quantify changes in mental health outcomes.

Music sessions occurred in a communal space and were integrated into the facility's daily schedule one hour prior to dinner. Caregivers remained present but unobtrusive during performances to minimize interference. Data were collected confidentially, and participants were informed of their right to withdraw at any time.

The study emphasized ecological validity by embedding the intervention in a real-world care environment without modifying existing pharmacological treatment plans. Findings were analyzed using standard statistical methods to determine within-subject change.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Receptive Music Therapy

Behavioral

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.

Primary outcomes

  1. Change in Geriatric Depression Scale (GDS) Score Among Residents

    Time frame: Within 2 weeks (pre- and post-intervention)

    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.

Secondary outcomes

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

    Time frame: Within 2 weeks (pre- and post-intervention)

    The Caregiver Burden Scale in End-of-Life Care (CBS-EOLC) is a validated 16-item self-report questionnaire that measures physical, emotional, and logistical strain experienced by caregivers. Scores range from 16 to 64, with higher scores indicating greater perceived burden. The secondary outcome is the change in caregiver burden scores from before to after the two-week music therapy intervention.

Sponsors and collaborators

Lead sponsor

Florida SouthWestern State College

Other

Collaborators

  • Stanford University

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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