Beyond Listening: A Music-based Intervention

Depressive Symptoms Clinical Trial

Official title:

Beyond Listening: A Music-based Caregiver Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840173
• Other study ID #: MJHSPalliative
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2022
• Source: MJHS Institute for Innovation in Palliative Care
• Contact: Kendra Ray, PhD
• Phone: 7183687927
• Email: kray[@]mjhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (Incl Subtypes)
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Music
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.

Locations

Country	Name	City	State
United States	Menorah Center for Nursing and Rehabilitation	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
MJHS Institute for Innovation in Palliative Care	Alzheimer's Association

Country where clinical trial is conducted

United States, 

References & Publications (7)

Gerdner 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. — View Citation

Kaufer 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. — View Citation

Ray 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. — View Citation

Ready 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. — View Citation

Särkämö 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/ge — View Citation

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, week 6 and month three
Primary	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.	Baseline, week 6 and month three
Primary	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.	Baseline, week 6 and month three
Secondary	Qualitative description of usefulness of music intervention	Caregivers will be asked to keep weekly diaries of their use of music with care recipient.	Diaries will be collected at week 6