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

NCT ID: NCT07069530

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-07-01

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.

Detailed Description

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.

Conditions

Dementia; Alzheimer Disease (AD); Depression Chronic; Caregiver Burden of People With Dementia; Cognitive Impairments

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Music Therapy Intervention Arm

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.

Group Type: EXPERIMENTAL

Receptive Music Therapy

Intervention Type: 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.

Interventions

Receptive Music Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Florida SouthWestern State College

OTHER

Sponsor Role: lead

Responsible Party

Hieu Nguyen

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hieu D Nguyen, Associates Degree

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Amavida Assisted Living

Fort Myers, Florida, United States

Countries

United States

Other Identifiers

#FSWHRP2022-1-29-01

Identifier Type: OTHER

Identifier Source: secondary_id

Music-2025

Identifier Type: -

Identifier Source: org_study_id