Alzheimer's Disease (Incl Subtypes)NCT04840173
Beyond Listening: A Music-based Intervention
A study testing Music in people with Alzheimer's Disease (Incl Subtypes) and Depressive Symptoms, run by MJHS Institute for Innovation in Palliative Care at 1 site in United States.
Trial summary
Study will be conducted to determine if caregivers who use music at home will feel less burden and whether the person they are caring for will demonstrate decreased symptoms of dementia. Caregivers will participate in a series of psycho-educational trainings for six weeks. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (Incl Subtypes), Depressive Symptoms
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Jul 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A diagnosis of dementia,
- person with dementia exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.,
- A family member or close friend of a person with dementia,
- Family member must be able to read or write in basic English.
Who cannot join
- Diagnosis or history of mental illness
- Inadequate hearing even with corrective device
- History of psychosis or other mental disorders other than depression
- History or presence of substance or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Menorah Center for Nursing and Rehabilitation
Brooklyn, New York, 11235
Kendra Ray, PhD, MPH, 718-646-4441 ext. 7927, kray@mjhs.org
Marion Kaiser, MS, 7186464441, mkaiser@mjhs.org
About this study
Official title: Beyond Listening: A Music-based Caregiver Intervention
Study will be conducted to determine if caregivers who use music at home will feel less burden and whether the person they are caring for will demonstrate decreased symptoms of dementia. Caregivers will participate in a series of psycho-educational trainings for six weeks. During this time, caregivers will learn how to use singing, music listening and music with movement with their family member. Caregivers should feel less stressed and a decreased sense of burden. The care recipient should appear happier with less occurrences of depression or restlessness.
Read the detailed description
Our study will incorporate caregivers and their care receivers who are diagnosed with dementia and agitation co-occurring depression. The primary study outcomes are the following: caregiver burden, measured with the Zarit Caregiver Burden Intervention; mood, measured with the Cornell-Brown Scale for Quality of Life; agitation, measured with the Neuropsychiatric Inventory Questionnaire; and focus group and diaries will be used to gain a descriptive account of caregiver experiences of facilitation of music intervention. Assessment time frame is focus group with caregivers, then pre-tests for baseline. Before the first workshop, caregivers will be asked to participate in a focus group with other caregivers.
Following pre-tests and focus group, caregivers will participate in a 6-week classroom workshop including the following topics: adding singing and music with movement to address mood or agitation, music listening to assist with transitions or difficult tasks, implementing background music for compliance during activities of daily living, creating individualized playlists/interventions to address undesirable behaviors, and the use of an MP3 player . The 6-week workshop will take place in person or via Zoom. Potential participants will be asked to meet for an hour, once weekly.
During the workshops, caregivers will be taught music-based interventions that involve adding singing and music with movement to address mood or agitation, music listening to assist with transitions or difficult tasks, background music for compliance and the creation of individualized playlists to address undesirable behaviors.
This psychosocial intervention will teach caregivers to incorporate a music-based intervention. The music-based intervention is a non-invasive program that involves singing, music with movement and music listening.
During these 6 weeks, caregivers will implement the music intervention with the care recipient and document weekly diaries. There will be a 3 month follow up designated for participants to repeat the completion of the questionnaires, Zarit Caregiver Burden Interview, Cornell-Brown Scale for Quality of Life, and Neuropsychiatric Inventory Questionnaire. These questions will be about participants' moods, agitation level or caregiver burden. This information will be collected in person at Menorah from potential caregiver participants. Principal Investigator will call to gather this data from the caregivers.
- Being tested
- Music
- Keywords
- Music Therapy, Music Interventions, Caregiver Singing, Family Caregivers, Dementia, Alzheimer's Disease, ADRD, Neuropsychiatric symptoms, Therapeutic music, Non-pharmacological interventions, Creative arts therapy, Vascular dementia, Behavioral and Psychological symptoms of dementia, Caregiver Burden, Depression, Agitation, Mood, Pleasure
- Medical subject headings
- Alzheimer Disease, Depression, Dementia, Dementia, Vascular, Behavior, Caregiver Burden, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
During attendance at a one hour, 6-week psychosocial classroom or virtual training, caregivers will learn to use singing and other music-based interventions, implementing them each week before the informational session.
| Study group | Role | What they receive |
|---|---|---|
| Music at home | Experimental | Caregivers will use Singing, music listening, or moving with music twice a week for 30 minutes with their care recipient. Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Mean of 12-item Zarit Caregiver Burden Interview at Week 6. The minimum score is 0 and maximum score is 88.
The Zarit Caregiver Burden is a validated, self-reported instrument assessing personal strain and role strain of family caregiver. Higher scores suggest more caregiver burden.
Measured: Baseline, week 6 and month three
Change from Baseline Quality of Life on the 19-item Cornell-Brown Scale for Quality of Life at Week 6. .
The Cornell-Brown Scale for Quality of Life is a validated measure assessing mood related bi-polar items such as anxiety vs comfort, sadness vs happiness, irritability vs tolerance, etc. for care recipients. This is completed by the caregiver on behalf of the care recipient. The minimum score for this measure is -38 and the maximum score is 38. A higher score indicates higher quality of life.
Measured: Baseline, week 6 and month three
Change from baseline symptoms on the 12-item Neuropsychiatric Inventory Questionnaire at Week 6.
The Neuropsychiatric Inventory Questionnaire is a validated measure completed by the caregiver on behalf of the care recipient assessing neuropsychiatric symptoms and behaviors associated with dementia. The scores range from 0 to 36 for individual symptoms. Higher scores indicate higher degrees of severity. Caregiver distress scores range from 0 to 55 with higher scores indicating higher distress.
Measured: Baseline, week 6 and month three
Secondary outcomes (1)
Qualitative description of usefulness of music intervention
Caregivers will be asked to keep weekly diaries of their use of music with care recipient.
Measured: Diaries will be collected at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Aug 2018
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease (Incl Subtypes)Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MJHS Institute for Innovation in Palliative Care
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840173
- Sponsor's protocol ID
- MJHSPalliative
- Status last verified
- Aug 2022
- First submitted
- 7 Apr 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Publications
Ziv N, Granot A, Hai S, Dassa A, Haimov I. The effect of background stimulative music on behavior in Alzheimer's patients. J Music Ther. 2007 Winter;44(4):329-43. doi: 10.1093/jmt/44.4.329.
PubMed 17997624Gerdner LA. Individualized music for dementia: Evolution and application of evidence-based protocol. World J Psychiatry. 2012 Apr 22;2(2):26-32. doi: 10.5498/wjp.v2.i2.26.
PubMed 24175165Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
PubMed 11001602Ray KD, Mittelman MS. Music therapy: A nonpharmacological approach to the care of agitation and depressive symptoms for nursing home residents with dementia. Dementia (London). 2017 Aug;16(6):689-710. doi: 10.1177/1471301215613779. Epub 2015 Oct 29.
PubMed 26519453Ready RE, Ott BR, Grace J, Fernandez I. The Cornell-Brown Scale for Quality of Life in dementia. Alzheimer Dis Assoc Disord. 2002 Apr-Jun;16(2):109-15. doi: 10.1097/00002093-200204000-00008.
PubMed 12040306Sarkamo T, Tervaniemi M, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist. 2014 Aug;54(4):634-50. doi: 10.1093/geront/gnt100. Epub 2013 Sep 5.
PubMed 24009169Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
PubMed 7203086
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Listening: A Music-based Caregiver Intervention
- ClinicalTrials.gov ID
- NCT04840173
- Acronym / sponsor ID
- MJHSPalliative
- Keywords
- Music Therapy, Music Interventions, Caregiver Singing, Family Caregivers, Dementia, Alzheimer's Disease, ADRD, Neuropsychiatric symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MJHS Institute for Innovation in Palliative CareUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 9 Apr 2021 (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.
Study will be conducted to determine if caregivers who use music at home will feel less burden and whether the person they are caring for will demonstrate decreased symptoms of dementia. Caregivers will participate in a series of psycho-educational trainings for six weeks. During this time, caregivers will learn how to use singing, music listening and music with movement with their family member. Caregivers should feel less stressed and a decreased sense of burden. The care recipient should appear happier with less occurrences of depression or restlessness.
Detailed description
Our study will incorporate caregivers and their care receivers who are diagnosed with dementia and agitation co-occurring depression. The primary study outcomes are the following: caregiver burden, measured with the Zarit Caregiver Burden Intervention; mood, measured with the Cornell-Brown Scale for Quality of Life; agitation, measured with the Neuropsychiatric Inventory Questionnaire; and focus group and diaries will be used to gain a descriptive account of caregiver experiences of facilitation of music intervention. Assessment time frame is focus group with caregivers, then pre-tests for baseline. Before the first workshop, caregivers will be asked to participate in a focus group with other caregivers.
Following pre-tests and focus group, caregivers will participate in a 6-week classroom workshop including the following topics: adding singing and music with movement to address mood or agitation, music listening to assist with transitions or difficult tasks, implementing background music for compliance during activities of daily living, creating individualized playlists/interventions to address undesirable behaviors, and the use of an MP3 player . The 6-week workshop will take place in person or via Zoom. Potential participants will be asked to meet for an hour, once weekly.
During the workshops, caregivers will be taught music-based interventions that involve adding singing and music with movement to address mood or agitation, music listening to assist with transitions or difficult tasks, background music for compliance and the creation of individualized playlists to address undesirable behaviors.
This psychosocial intervention will teach caregivers to incorporate a music-based intervention. The music-based intervention is a non-invasive program that involves singing, music with movement and music listening.
During these 6 weeks, caregivers will implement the music intervention with the care recipient and document weekly diaries. There will be a 3 month follow up designated for participants to repeat the completion of the questionnaires, Zarit Caregiver Burden Interview, Cornell-Brown Scale for Quality of Life, and Neuropsychiatric Inventory Questionnaire. These questions will be about participants' moods, agitation level or caregiver burden. This information will be collected in person at Menorah from potential caregiver participants. Principal Investigator will call to gather this data from the caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music at home | Experimental | Behavioral: MusicCaregivers will use Singing, music listening, or moving with music twice a week for 30 minutes with their care recipient. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of dementia,
- person with dementia exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc.,
- A family member or close friend of a person with dementia,
- Family member must be able to read or write in basic English.
Key exclusion criteria (4 listed)
- Diagnosis or history of mental illness
- Inadequate hearing even with corrective device
- History of psychosis or other mental disorders other than depression
- History or presence of substance or alcohol abuse.
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 |
|---|---|---|
| MusicDuring attendance at a one hour, 6-week psychosocial classroom or virtual training, caregivers will learn to use singing and other music-based interventions, implementing them each week before the informational session. | Behavioural | Music at home |
Primary outcome
Change from Baseline in the Mean of 12-item Zarit Caregiver Burden Interview at Week 6. The minimum score is 0 and maximum score is 88.
Time frame: Baseline, week 6 and month three
The Zarit Caregiver Burden is a validated, self-reported instrument assessing personal strain and role strain of family caregiver. Higher scores suggest more caregiver burden.
Change from Baseline Quality of Life on the 19-item Cornell-Brown Scale for Quality of Life at Week 6. .
Time frame: Baseline, week 6 and month three
The Cornell-Brown Scale for Quality of Life is a validated measure assessing mood related bi-polar items such as anxiety vs comfort, sadness vs happiness, irritability vs tolerance, etc. for care recipients. This is completed by the caregiver on behalf of the care recipient. The minimum score for this measure is -38 and the maximum score is 38. A higher score indicates higher quality of life.
Change from baseline symptoms on the 12-item Neuropsychiatric Inventory Questionnaire at Week 6.
Time frame: Baseline, week 6 and month three
The Neuropsychiatric Inventory Questionnaire is a validated measure completed by the caregiver on behalf of the care recipient assessing neuropsychiatric symptoms and behaviors associated with dementia. The scores range from 0 to 36 for individual symptoms. Higher scores indicate higher degrees of severity. Caregiver distress scores range from 0 to 55 with higher scores indicating higher distress.
1 secondary outcome
Qualitative description of usefulness of music intervention
Time frame: Diaries will be collected at week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 17997624Ziv N, Granot A, Hai S, Dassa A, Haimov I. The effect of background stimulative music on behavior in Alzheimer's patients. J Music Ther. 2007 Winter;44(4):329-43. doi: 10.1093/jmt/44.4.329.
- Results publication: PubMed 24175165Gerdner LA. Individualized music for dementia: Evolution and application of evidence-based protocol. World J Psychiatry. 2012 Apr 22;2(2):26-32. doi: 10.5498/wjp.v2.i2.26.
- Results publication: PubMed 11001602Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
- Results publication: PubMed 26519453Ray KD, Mittelman MS. Music therapy: A nonpharmacological approach to the care of agitation and depressive symptoms for nursing home residents with dementia. Dementia (London). 2017 Aug;16(6):689-710. doi: 10.1177/1471301215613779. Epub 2015 Oct 29.
- Results publication: PubMed 12040306Ready RE, Ott BR, Grace J, Fernandez I. The Cornell-Brown Scale for Quality of Life in dementia. Alzheimer Dis Assoc Disord. 2002 Apr-Jun;16(2):109-15. doi: 10.1097/00002093-200204000-00008.
- Results publication: PubMed 24009169Sarkamo T, Tervaniemi M, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist. 2014 Aug;54(4):634-50. doi: 10.1093/geront/gnt100. Epub 2013 Sep 5.
- Results publication: PubMed 7203086Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Alzheimer's Disease (Incl Subtypes) and Depressive Symptoms, run by MJHS Institute for Innovation in Palliative Care 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kendra Ray, PhD (7183687927, kray@mjhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Mean of 12-item Zarit Caregiver Burden Interview at Week 6. The minimum score is 0 and maximum score is 88. (time frame: Baseline, week 6 and month three). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840173, which also lists 7 linked publications.
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 24 Aug 2022.