DementiaNCT07069530
Impact of Musical Therapeutic Intervention on Depression in Dementia Patients and Caregiver Burden
A study testing Receptive Music Therapy in people with Dementia and Alzheimer Disease (AD), run by Florida SouthWestern State College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease (AD), Depression Chronic
- What is being tested?
- Receptive Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Receptive Music Therapy
- Keywords
- Music Therapy, Dementia, Depression, Alzheimer's Disease, Caregiver Burden, Receptive Music Intervention
- Medical subject headings
- Dementia, Alzheimer Disease, Cognitive Dysfunction, Depression, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receptive Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Receptive Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 weeks (pre- and post-intervention)
Secondary outcomes (1)
Change in Caregiver Burden Scale in End-of-Life Care (CBS-EOLC) Score
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.
Measured: Within 2 weeks (pre- and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida SouthWestern State College
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Hieu Nguyen, Florida SouthWestern State College
- Investigators
- Hieu D Nguyen, Associates Degree, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069530
- Sponsor's protocol ID
- Music-2025
- Other IDs
- #FSWHRP2022-1-29-01
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Musical Therapeutic Intervention on Depression in Dementia Patients and Caregiver Burden
- ClinicalTrials.gov ID
- NCT07069530
- Acronym / sponsor ID
- Music-2025
- Conditions
- Dementia, Alzheimer Disease (AD), Depression Chronic, Caregiver Burden of People With Dementia, Cognitive Impairments
- Keywords
- Music Therapy, Dementia, Depression, Alzheimer's Disease, Caregiver Burden, Receptive Music Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Florida SouthWestern State CollegeUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Intervention Arm | Experimental | Behavioral: Receptive Music TherapyParticipants 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. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receptive Music TherapyParticipants 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. | Behavioural | Music Therapy Intervention Arm |
Primary outcome
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.
1 secondary outcome
Change in Caregiver Burden Scale in End-of-Life Care (CBS-EOLC) Score
Time frame: Within 2 weeks (pre- and post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hieu D Nguyen, Associates Degree principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receptive Music Therapy in people with Dementia and Alzheimer Disease (AD), run by Florida SouthWestern State College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Geriatric Depression Scale (GDS) Score Among Residents (time frame: Within 2 weeks (pre- and post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.