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Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

196 Participants Needed

Music Therapy for Dementia
(MCTM Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Hearthstone Institute, LLC

Disqualifiers: Dementia, Cognitive impairment, Rapid decline

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

Trial Summary

What is the purpose of this trial?

Healthcare systems around the world, including within the United States, have long-established shortages of trained caregivers. The American Health Care Association states that "the health care system has experienced a shortage of trained caregivers for critical roles for some time." This scarcity directly impacts the 45,800 Long-Term Care (LTC) communities throughout the U.S. Concurrent with this staff shortage, more than half of LTC residents have some form of dementia. These two issues create a serious public health concern, since dementia is associated with a variety of behavioral expressions, such as aggression, anxiety, and agitation. Behavioral expressions of dementia can be successfully managed with the use of tailored, psychosocial interventions and communication support. Unfortunately, existing staff shortages make the facilitation of such interventions challenging. One powerful and often-overlooked approach to ameliorating staffing shortages involves the utilization of retired volunteers to facilitate interventions for persons with dementia (PWD). Based on the nearly universal love of music and a promising pilot study, the product to be developed and tested in this STTR will build upon the combined prior work of the Principal Investigators. Making Connections Thru Music (MCTM), an urgently needed product, will enable retired volunteers to facilitate an evidence-based music and discussion intervention with PWD. MCTM aims to improve engagement, enhance quality of life, and reduce behavioral expressions in PWD. The intervention will consist of two main components: (1) a comprehensive online training course for volunteers, which will provide a general overview of dementia, demonstrate effective communication strategies to use with PWD, and instruct volunteers to effectively facilitate MCTM sessions, and (2) an app containing a structured MCTM intervention protocol and toolkit, which will be the means by which volunteers facilitate MCTM. MCTM will be marketed to LTC communities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Making Connections Thru Music for dementia?

Research shows that music therapy can help improve mood, behavior, and engagement in people with dementia. Studies have developed tools to measure these positive effects, indicating that music therapy can be a valuable treatment for managing symptoms of 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 aims to improve mood and reduce agitation without the use of medication. However, more research is needed to fully understand its effects and ensure its safety across different settings.⁶ ⁷ ⁸ ⁹ ¹⁰

How is the 'Making Connections Thru Music' treatment different from other treatments for dementia?

The 'Making Connections Thru Music' treatment is unique because it involves training family caregivers to use music intentionally in daily routines with their loved ones who have dementia, enhancing their quality of life and wellbeing. Unlike other treatments, it empowers caregivers to apply music therapy techniques at home, even when professional music therapists are not present.⁶ ¹¹ ¹² ¹³ ¹⁴

Eligibility Criteria

This trial is for volunteers aged 55+ and staff at residential care facilities, both groups must speak/read English. Residents with dementia eligible for the study must be diagnosed with any type of dementia, score 10+ on MMSE, be aged 65+, and speak/read English. Those showing rapid decline or working third shift only are excluded.

Inclusion Criteria

I am over 18, work in a care facility in the study, and speak English.

I am 55 years old or older and can speak and read English.

Exclusion Criteria

I am not experiencing a fast decline in my physical or mental abilities.

Staff members will be excluded if they work third shift only.

I am 65 or older, diagnosed with dementia, can speak English, and scored 10+ on the MMSE.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Baseline

Initial assessment and baseline measurements are conducted

4 weeks

1 visit (in-person)

Treatment

Participants receive the MCTM intervention facilitated by volunteers or professionals

8 weeks

Weekly sessions

Follow-up

Participants are monitored for engagement and behavioral changes post-intervention

4 weeks

Treatment Details

Interventions

Making Connections Thru Music

Trial OverviewThe trial tests 'Making Connections Thru Music' (MCTM), a program where retired volunteers facilitate music-based interventions to improve engagement and quality of life in people with dementia. It includes an online training course for volunteers and an app containing the intervention protocol.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: MCTM InterventionExperimental Treatment1 Intervention

Activity sessions will be led by activity volunteers

Group II: ControlActive Control1 Intervention

Activity sessions will be led by activity professionals

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hearthstone Institute, LLC

Lead Sponsor

Trials

Recruited

490+

Hopeful Aging

Lead Sponsor

Trials

Recruited

610+

Benjamin Rose Institute on Aging

Collaborator

Trials

Recruited

2,600+

Findings from Research

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]

Current research on music therapy for dementia lacks rigorous methodological design, making it difficult to draw strong conclusions about its effectiveness.

Despite the absence of reliable empirical evidence, existing studies suggest that music therapy may have potential benefits in managing dementia symptoms, highlighting the need for better-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for dementia symptoms.Koger, SM., Brotons, M.[2018]

Current research on music therapy for dementia lacks rigorous methodological design, making it difficult to draw definitive conclusions about its effectiveness.

Despite the absence of strong empirical evidence, the available studies suggest that music therapy may have potential benefits in managing dementia symptoms, highlighting the need for more well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for dementia symptoms.Koger, SM., Brotons, M.[2020]