Beyond Listening: A Music-based Intervention

NCT04840173 | Unknown

• 1 other identifier: MJHSPalliative
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease (Incl Subtypes); Depressive Symptoms

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Qualitative description of usefulness of music intervention

  Diaries will be collected at week 6

Study Arms (1)

Music at home

EXPERIMENTAL

Caregivers will use Singing, music listening, or moving with music twice a week for 30 minutes with their care recipient.

Behavioral: Music

Interventions

Music BEHAVIORAL

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.

Music at home

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MJHS Institute for Innovation in Palliative Care: lead
• Alzheimer's Association: collaborator

Study Sites (1)

Menorah Center for Nursing and Rehabilitation

Brooklyn, New York, 11235, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 17997624 BACKGROUND

• 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.

  PMID: 24175165 RESULT

• 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. doi: 10.1176/jnp.12.2.233.

  PMID: 11001602 RESULT

• 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.

  PMID: 26519453 RESULT

• 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. doi: 10.1097/00002093-200204000-00008.

  PMID: 12040306 RESULT

• Sarkamo 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.

  PMID: 24009169 RESULT

• Zarit 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.

  PMID: 7203086 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Depression; Dementia; Dementia, Vascular; Behavior; Caregiver Burden; Psychomotor Agitation

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Kendra Ray, PhD

CONTACT

7183687927; kray@mjhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: August 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be available following the study for one year.
• Access Criteria: Individuals interested in accessing the study protocol can reach out to the PI via email at kray@mjhs.org

Locations

US (1)