Music Therapy for Severe Dementia

(AMUSED Trial)

Recruiting at1 trial location

Overseen by Alaine E Reschke-Hernandez, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Alaine E Hernandez, PhD

Disqualifiers: Music therapy recipient, Movement disorder, Cognitive disability, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this pilot randomized clinical trial is to learn if a music therapy treatment, called AMUSED, can improve engagement and reduce behavioral symptoms in older adults with severe dementia who live in care facilities. The main questions it aims to answer are: * Is it feasible to conduct a full-scale trial of AMUSED? * Can investigators identify the best outcome measures to assess impact on behavioral symptoms of dementia? * Does speech offer a useful indicator of treatment effectiveness? Researchers will compare a group-based music therapy treatment to a reading activity to learn if music therapy leads to greater improvements in behavioral symptoms and speech patterns. Participants will: * Participate in either music therapy (includes live music, singing, and rhythmic instrument playing) or a reading group with stories about life and nature and talk about memories. * Attend small group sessions twice a week for 12 weeks, with each session lasting 40 minutes between lunch and dinner. * Be observed and assessed for behavioral symptoms, cognition, and speech several times during treatment and at a 4-week follow-up.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What data supports the effectiveness of the treatment AMUSED for severe dementia?

Research shows that music therapy can help improve mood, reduce agitation, and enhance quality of life in people with dementia. Personalized music interventions have been found to reduce the need for medications and improve cognitive and emotional functions, especially in those with mild to moderate dementia. ^{1 2 3 4 5}

Is music therapy safe for people with dementia?

Music therapy is generally considered safe for people with dementia, as it is a non-drug approach that can help improve mood and reduce agitation without the side effects associated with medications. ^{6 7 8 9 10}

How is the treatment AMUSED different from other treatments for severe dementia?

AMUSED, a music therapy treatment, is unique because it uses music to improve mood and behavior in people with severe dementia, offering a non-drug approach that can enhance quality of life and reduce the need for medications. ^{11 12 13 14 15}

Research Team

Alaine E Reschke-Hernandez, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for older adults with severe dementia living in care facilities. They should be able to attend small group sessions and participate in activities. There are no specific inclusion or exclusion criteria provided, but typically participants must meet certain health conditions and not have factors that would prevent them from fully participating.

Inclusion Criteria

English is primary language

I am 65 years old or older.

Dementia is severe: Residents' charted score on the Brief Inventory of Mental Status (BIMS) < 7 and no independent function in community affairs, hobbies, chores, or personal care

Exclusion Criteria

Milder dementia (BIMS 7+)

Preexisting cognitive disability

I have received music therapy.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline measures are taken before the intervention begins

1 week

Treatment

Participants receive either music therapy or reading sessions twice a week for 12 weeks

12 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for behavioral symptoms, cognition, and speech after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• AMUSED (Behavioural Intervention)

Trial Overview The study tests if AMUSED, a music therapy involving live music, singing, and instruments can improve engagement and reduce behavioral symptoms compared to reading aloud about life stories. It's a pilot randomized trial where participants join twice-weekly sessions for 12 weeks to determine the feasibility of a full-scale trial.

Participant Groups

Group I: Music Therapy Experimental Treatment 1 Intervention

Live delivery of a music therapy protocol that is designed to be led by a board-certified music therapist (MT-BC). Activity blocks are identical to the reading arm: * T0 Baseline measures * Weeks 1-4: music therapy intervention * T1 measures (end of week 4) * Weeks 5-8: music therapy intervention * T2 measures (end of week 8) * Weeks 5-8: music therapy intervention * T3 measures (end of week 12) * T4 measures 4-week-follow-up (week 16)

Group II: Reading Aloud Active Control 1 Intervention

Live reading aloud of an age-appropriate book by a group leader to control for social attention and isolate the effects of music. Activity blocks are identical to the music therapy arm: * T0 Baseline measures * Weeks 1-4: music therapy intervention * T1 measures (end of week 4) * Weeks 5-8: music therapy intervention * T2 measures (end of week 8) * Weeks 5-8: music therapy intervention * T3 measures (end of week 12) * T4 measures 4-week-follow-up (week 16)

Who Is Running the Clinical Trial?

Alaine E Hernandez, PhD

Lead Sponsor

Trials

2

Recruited

70+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

A pilot study involving 25 older patients with delirium and/or dementia showed that creative music therapy (CMT) significantly improved mood and engagement, as evidenced by positive changes in engagement and pleasure ratings during therapy sessions.

CMT not only increased constructive engagement and pleasure but also reduced negative engagement and affect, suggesting it could be a beneficial intervention in acute hospital settings to enhance patient cooperation and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creative Music Therapy in an Acute Care Setting for Older Patients with Delirium and Dementia. Cheong, CY., Tan, JA., Foong, YL., et al.[2023]

A randomized clinical trial involving 32 residents with Alzheimer's disease and related dementias showed that a singing-based music therapy intervention significantly improved feelings, positive emotions, and social engagement compared to a non-music condition (verbal discussion).

The positive effects of music therapy were particularly notable in individuals with moderate dementia, suggesting that music interventions can enhance psychosocial well-being in this population and should be tailored to patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music Therapy Increases Social and Emotional Well-Being in Persons With Dementia: A Randomized Clinical Crossover Trial Comparing Singing to Verbal Discussion. Reschke-Hernández, AE., Gfeller, K., Oleson, J., et al.[2023]

The Music, Mind, and Movement (MMM) program, consisting of seven weekly group sessions, showed promising improvements in global cognition for 8 out of 12 participants with mild to moderate dementia, particularly in attention and verbal fluency.

In contrast, participants receiving standard care experienced a decline in cognition, highlighting the potential therapeutic benefits of music-based interventions for enhancing cognitive function in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 'Music, Mind and Movement' Program for People With Dementia: Initial Evidence of Improved Cognition. Brancatisano, O., Baird, A., Thompson, WF.[2023]

A pilot study involving 21 hospitalized patients with dementia demonstrated that a personalized music listening intervention is feasible for nursing staff to implement in a geriatric unit, potentially enhancing patient engagement and clinical efficiency.

While the results on agitation reduction were inconclusive due to the small sample size, the study suggests that non-pharmacological approaches like music could challenge the reliance on psychotropic medications for managing agitation in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a personalised music listening intervention decrease agitation in hospitalised patients with dementia? A feasibility trial. Lee, S., Chan, L., Maddison, J.[2023]

A pilot study involving 18 dementia-caregiver dyads showed that home-based neurologic music therapy (NMT) significantly improved neuropsychiatric symptoms after 6 weeks, with benefits maintained at 12 weeks for those who completed the therapy.

However, 38.9% of participants withdrew from the study, particularly those with more severe symptoms, suggesting that starting NMT earlier in the dementia progression may be more beneficial for both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Home-Based Neurologic Music Therapy for Behavioral and Psychological Symptoms of Dementia: A Pilot Study. Holden, SK., Sheffler, J., Stewart, R., et al.[2019]

Music therapy has been shown to provide significant benefits for individuals with dementia, helping to manage symptoms and improve their overall environment.

Early research suggests that music therapy may reduce the reliance on psychotropic medications, offering a safer alternative for managing dementia-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy for dementia patients. Hsu, MH.[2017]

Music therapy can provide therapeutic benefits for patients with Alzheimer's dementia by improving their overall well-being and potentially reflecting their progress in managing the disease.

Engaging in music therapy sessions may help alleviate some cognitive disorders associated with Alzheimer's, enhancing the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy and Alzheimer disease]. Tromeur, E.[2014]

In a study involving nine individuals with advanced dementia, music therapy was found to have a positive impact on the mood and behavior of eight participants, indicating its potential benefits in this population.

The effects of music therapy were assessed through case notes completed by nursing and care staff, highlighting its practical application in a hospital setting for improving patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

But does it do any good? Measuring the impact of music therapy on people with advanced dementia: (Innovative practice). Gold, K.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Active Music Therapy and Individualized Listening to Music on Dementia: A Multicenter Randomized Controlled Trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical and Demographic Factors Associated with the Cognitive and Emotional Efficacy of Regular Musical Activities in Dementia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pragmatic Trial of Personalized Music for Agitation and Antipsychotic Use in Nursing Home Residents With Dementia. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Alzheimer's disease: rhythm, timing and music as therapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Addendum to 'Efficacy of music therapy treatment based on cycles of sessions: a randomised controlled trial' (Raglio et al., 2010). [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Creative Music Therapy in an Acute Care Setting for Older Patients with Delirium and Dementia. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Music Therapy Increases Social and Emotional Well-Being in Persons With Dementia: A Randomized Clinical Crossover Trial Comparing Singing to Verbal Discussion. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A 'Music, Mind and Movement' Program for People With Dementia: Initial Evidence of Improved Cognition. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Can a personalised music listening intervention decrease agitation in hospitalised patients with dementia? A feasibility trial. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility of Home-Based Neurologic Music Therapy for Behavioral and Psychological Symptoms of Dementia: A Pilot Study. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Therapy for dementia patients. [2017]

12. France pubmed.ncbi.nlm.nih.gov

[Music therapy and Alzheimer disease]. [2014]

13. England pubmed.ncbi.nlm.nih.gov

Music therapy in moderate and severe dementia of Alzheimer's type: a case-control study. [2016]

14. England pubmed.ncbi.nlm.nih.gov

But does it do any good? Measuring the impact of music therapy on people with advanced dementia: (Innovative practice). [2014]

15. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Music Therapy-Singing Group on Quality of Life and Affect of Persons With Dementia: A Randomized Controlled Trial. [2020]