Music Therapy for Severe Dementia

(AMUSED Trial)

Recruiting at 2 trial locations

Overseen By Alaine E. Reschke-Hernandez, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Alaine E Hernandez, PhD

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if music therapy, known as AMUSED, can improve engagement and reduce behavioral issues in older adults with severe dementia living in care facilities. Researchers seek to establish the feasibility of a larger study and identify the best methods to measure changes in behavior and speech. Participants will either join group music therapy sessions, which include activities like live music and singing, or participate in a reading group. The trial seeks residents in care facilities who have severe dementia and do not currently receive music therapy. As an unphased study, this trial provides a unique opportunity to explore innovative therapies that could enhance quality of life.

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 prior data suggests that this music therapy treatment is safe for older adults with severe dementia?

Research has shown that music therapy is generally safe and well-tolerated for people with dementia. Past studies have found that music therapy significantly lowers anxiety, depression, and lack of interest in patients. One study showed that music therapy helped reduce disruptive behavior over six weeks. These results suggest that music therapy, such as AMUSED, is unlikely to cause harm and is probably safe for participants.

Although detailed safety information specifically for AMUSED is not available, music therapy in similar situations has been linked to positive results and is considered low risk. This makes it a promising option for those interested in joining this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about music therapy for severe dementia because it offers a non-drug approach that focuses on stimulating memory and emotions through music, potentially enhancing the quality of life for patients. Unlike standard dementia treatments that often involve medications targeting neurotransmitters, music therapy provides a personalized, interactive experience led by a trained music therapist. This method could offer a meaningful and enjoyable way to engage patients, promoting cognitive and emotional benefits without the side effects associated with pharmaceuticals.

What evidence suggests that music therapy might be an effective treatment for severe dementia?

This trial will compare the effects of music therapy with reading aloud for individuals with severe dementia. Studies have shown that music therapy can improve mood and reduce restlessness in people with severe dementia. Research indicates that music therapy may also help people find words and speak more easily. Additionally, music therapy has been linked to reduced anxiety, depression, and apathy in dementia patients. Evidence suggests that music therapy can enhance thinking skills, such as memory and decision-making. Overall, these findings suggest that music therapy, like AMUSED, might effectively increase engagement and reduce behavioral symptoms in severe dementia. ^{1 2 3 6 7}

Who Is on the Research Team?

Alaine E Reschke-Hernandez, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• AMUSED

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

In a study involving 89 dementia patients and their caregivers, a 10-week music coaching intervention showed that singing improved working memory in patients with mild dementia and helped maintain executive function in younger patients.

Music listening supported general cognition and quality of life in patients with moderate dementia not caused by Alzheimer's disease, while both interventions reduced depression in patients with mild dementia and Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Demographic Factors Associated with the Cognitive and Emotional Efficacy of Regular Musical Activities in Dementia. Särkämö, T., Laitinen, S., Numminen, A., et al.[2022]

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]

In a randomized controlled study with 60 patients, music therapy (MT) combined with standard care showed a significant positive impact on behavioral disturbances in individuals with moderate to severe dementia, as indicated by changes in Neuropsychiatric Inventory (NPI) global scores.

Although the benefits of MT were evident during the treatment phase, both the experimental and control groups experienced worsening of symptoms after treatment ended, suggesting that while MT is effective, its benefits may diminish over time without continued intervention.

NCBI (Pubmed)

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). Raglio, A., Bellelli, G., Traficante, D., et al.[2018]

Active music-making can serve as an effective therapy for Alzheimer's patients, helping to maintain cognitive functions and improve quality of life through social interaction and self-expression.

Music therapy may reduce the need for tranquilizers and hypnotics, promoting mood improvement and enhancing mental processes, suggesting it could be a valuable part of rehabilitation strategies for Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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 randomized controlled trial involving 120 participants with moderate to severe dementia, both active music therapy (MT) and individualized listening to music (LtM) did not show significant differences in reducing behavioral and psychological symptoms of dementia (BPSDs) compared to standard care.

However, all groups experienced a reduction in symptoms over time, with the MT group showing a 28% decrease in the Neuropsychiatric Inventory (NPI) global score, suggesting that while music interventions may not significantly outperform standard care, they could still contribute to overall symptom improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Active Music Therapy and Individualized Listening to Music on Dementia: A Multicenter Randomized Controlled Trial. Raglio, A., Bellandi, D., Baiardi, P., et al.[2022]

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 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 personalized music intervention did not significantly reduce agitated behaviors in nursing home residents with dementia, as measured by the Cohen-Mansfield Agitation Inventory and other behavior assessments, involving 976 participants across 54 facilities.

While there was a slight reduction in the use of antipsychotic medications among residents receiving the music intervention, this difference was not statistically significant, indicating that the intervention may not have a meaningful impact on medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic Trial of Personalized Music for Agitation and Antipsychotic Use in Nursing Home Residents With Dementia. McCreedy, EM., Sisti, A., Gutman, R., et al.[2023]

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]

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]

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]

In a study involving 38 patients with moderate to severe Alzheimer's disease, music therapy significantly reduced activity disturbances, aggressiveness, and anxiety over a 6-week period.

The positive effects of music therapy were temporary, as most benefits diminished after four weeks, indicating that while it is a safe and effective intervention, ongoing treatment may be necessary for sustained results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study involving 52 participants aged 67 to 99, music therapy with active group singing significantly improved quality of life and emotional well-being in individuals with dementia compared to music listening and control groups.

The music therapy-singing group showed notable increases in positive affect and decreases in negative affect, highlighting its potential as an effective non-pharmacological intervention for enhancing the emotional health of dementia patients in long-term care settings.

NCBI (Pubmed)

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. Cho, HK.[2020]

Citations

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A Multimodal Music Therapy Intervention for Engaging ... 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 ...

2. uky.trialstoday.org uky.trialstoday.org/trial/NCT06605157

A Multimodal Music Therapy Intervention for Engaging ... The goal of this pilot randomized clinical trial is to learn if a music therapy treatment, called AMUSED, can improve engagement and reduce ...

3. withpower.com withpower.com/trial/phase-dementia-9-2024-2a81a

Music Therapy for Severe Dementia (AMUSED Trial) What data supports the effectiveness of the treatment AMUSED for severe dementia? Research shows that music therapy can help improve mood, reduce agitation ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7709645/

Effects of Music Therapy on Patients with Dementia—A ... Significant improvements in verbal fluency occurred after music therapy, with significant reductions in anxiety, depression, and apathy.

5. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-023-01214-9

The effect of music therapy on cognitive functions in patients ... The results showed that compared to different control groups, there is an improvement in cognitive functions after music therapy application.

6. nature.com nature.com/articles/s44220-024-00342-x

How and why music therapy reduces distress ... A Cochrane review of music-based interventions for people with dementia reported moderate-quality evidence for reduction in depression and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224048671

Music therapy in moderate and severe dementia of ... Results: The study showed a significant reduction in activity disturbances in the music therapy group during a 6-week period measured with the Behavior ...