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Healthy AgingMusiCareNCT04851028

MusiCare: Music Therapy & Innovative Technology

A study testing Music Therapy in people with Healthy Aging and Cognitive Impairment, run by Middlesex University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The number of older people living with cognitive impairment or dementia has increased the need for simple, inexpensive interventions to improve the quality of life for such individuals and their families. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Aging, Cognitive Impairment
What is being tested?
Music Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteUnited Kingdom
Study dates
1 Apr 2022to 26 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Aged ≥65yrs
  • No significant hearing impairment that would negatively interfere with the music-based interventions
  • Fluent in English
  • Healthy group - MMSE ≥ 24
  • Cognitive impairment: mild MMSE= 18-23, moderate MMSE= 10-17

Who cannot join

  • Presence of severe motor deficits that would not allow individuals to participate in the intervention
  • Having taken part in a cognitive training programme or Music Therapy programme within the last 6 months.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • MHA Methodist Homes

    Derby, DE1 2EQ

Other trials in United Kingdom

About this study

Official title: MusiCare: Protecting Cognitive Functions and Wellbeing Using Music Therapy & Innovative Technology With an Aging Population

The number of older people living with cognitive impairment or dementia has increased the need for simple, inexpensive interventions to improve the quality of life for such individuals and their families. Policy-makers sensitive to issues associated with mental health challenges in aging have embraced social prescribing, and a wealth of research has flourished to study non-pharmacological forms of preventative intervention. Can music-therapy(MT) be one of them? Different studies demonstrated that music stimulates a range of cognitive and social functions. However, scientific studies assessing the value of MT for those who need support in later life are limited, and rigorous research is required to generate robust scientific evidence. The focus of this study is on developing novel forms of intervention for older adults who are healthy or experiencing mild-to-moderate cognitive decline, aiming at [i]understanding whether MT could be used in preventive programs to support cognitive functions, [ii]identifying the best match between types of MT and levels of cognitive decline. Moreover, recent developments of Robotic-Assistance-Technologies offer opportunities to explore how such technologies may be used to contribute to older adults wellbeing when integrated within care routines to facilitate MT delivery.

Spanning across three-studies, the investigators will examine psychosocial benefits of 5-month MT interventions (one2one, small-group MT, large-group MT) in healthy older adults and impaired older adults in care homes, compared to standard care. This latter group will receive MT afterwards. Further, researchers will investigate whether Robotic-Assistance-Technologies may enrich MT interventions and have additional benefits for the participants and translatability for community-based services.

Read more

In order to measure these effects, psychological (cognitive functions, wellbeing, quality of life) and physiological (hormonal, cardiovascular \& brain activity) measures will be compared before/after the intervention.

The study will elucidate relationships between different types of MT and benefits to participants wellbeing, cognitive functions \& social engagement, as well as the impact of robotic assistive technologies in public health services and social care.

Read the detailed description

The following objectives are addressed:

[Oi] Identifying a consistent set of convergent measures for the reliable assessment of cognition/well-being in MT studies integrating psychological measures with biomarkers; [Oii] Implementing robust MT protocols benefitting cognitive functions/well-being in ageing individuals with varying cognitive ability; [Oiii] Comparing the outcomes of one2one/small-group/large-group MT intervention in function of participants' cognitive abilities (ranging from healthy ageing to moderate impairment); [Oiv] Devising, implementing and testing a robotic platform associated with MT to facilitate therapists/caregivers' work through novel forms of interaction with ageing individuals, and potential translatability to communities.

Our research questions/hypotheses are:

[H1] Will MT benefits healthy, mildly and moderately impaired 65+ in outcome measures? MT > standard care.

[H2] Which MT treatment (one2one/small group/large group) is more effective in function of older adults' cognitive level? Best outcomes predicted as follows: healthy 65+ with small-group MT; for mildly impaired 65+, one2one = small-group MT<large group; moderately impaired 65+ with one2one MT.

[H3] Will improvements in cognitive functions derived from MT be associated with psychophysiological biomarkers? Convergent measures will be identified linking cognitive, behavioural and physiological improvement.

[H4] What are the benefits of MT for caregivers? A reduction in participant psychiatric and depressive symptoms will correspond to caregivers' workload and stress perception decrease.

[H5] Are there benefits from enriching MT with robotic technology? Specifically, the investigators hypothesize that a) the robot will have the capability of delivering interactive music training sessions, with the support of caregivers not specialised in MT and b) the continuous monitoring provided by the robotic platform will enhance the information available to therapists/caregivers without significantly burdening them.

MusiCare aims are:

[Ai] Provide care-homes, communities and policy-makers with clear guidelines concerning the utility, suitability and cost-effectiveness of Music Therapy (MT) interventions (one2one vs small-group vs large group) as a prevention/rehabilitation method suitable for social prescribing and support for positive ageing.

[Aii] Provide music therapists with robust protocols, new tests specifically designed to work through musical tasks (Music Cognitive Test).

[Aiii] Provide scholars/practitioners with a range of objective measures to select from, depending on their needs, in order to evaluate MT interventions in ageing.

[Aiv] Explore how the assistive robotic technologies can enrich MT in care-home settings by empowering care-home staff with a new active role in assisting rehabilitative activities as well as facilitating inter-generational communication between families and ageing relatives.

[Av] Increase public awareness about healthy ageing, and arts \& wellbeing.

Being tested
Music Therapy
Keywords
music therapy, aging, cognitive function, robotics
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music TherapyBehavioural

    Music therapy is a non-pharmacological intervention, in which music and its elements are used professionally as an intervention in medical, educational, and everyday environments with individuals, groups, families, or communities who seek to optimize their quality of life and improve their physical, social, communicative, emotional, intellectual, and spiritual health and wellbeing. This therapy has shown to provide significant benefits for individuals with cognitive decline living in care homes, enhancing social-cognitive functions and reducing behavioural symptoms (Brotons \& Koger, 2000; Hsu et al., 2015; Zhang et al., 2017).

Study groups in NCT04851028
Study groupRoleWhat they receive
One2OneExperimental1) Weekly individual (one2one) Music Therapy intervention lasting 5 months (n=20 sessions)
Receives: Behavioral: Music Therapy
Small-groupExperimental2) Weekly small group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)
Receives: Behavioral: Music Therapy
Large groupExperimental3) Weekly Large group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)
Receives: Behavioral: Music Therapy
ControlNo interventionPassive control, not attending any music-related activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General cognitive functions change from baseline/post (i.e., time 0/+5 months)

    Mini-Mental State Examination (MMSE, Folstein et al., 1975): A world standardized tool for screening general cognitive function which allows the client to be placed on a cognitive functioning scale. This test is usually used to follow the course of a disease or for monitoring the response to a specific treatment, as in this case.

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

  2. Music related cognitive function change from baseline/post (i.e., time 0/+5 months)

    Music Cognitive Test (MCT, Mangiacotti, 2019; - et al., 2019b) A music-based cognitive test to measure cognitive functions typically stimulated by rehabilitative music interventions.

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

  3. Attentional functions change from baseline/post (i.e., time 0/+5 months)

    TMT-A (Reitan \& Wolfoson, 1985) The test assesses selective attention and psychomotor speed.

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

  4. Executive and spatial-cognitive abilities change from baseline/post (i.e., time 0/+5 months)

    Tangled Figure Test (Arcara et al., 2011) The test wants to evaluate participant's ability to perform figure-background discrimination and inhibition on the answers already provided as well as to recognize the contours of the figures. Mainly it is a test of visual recognition, but it requires the ability to reorganize a complex visual pattern in order to identify an increasing number of figures. Provides information on spatial-cognitive abilities, and executive and naming difficulties.

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

Secondary outcomes (6)

  1. Quality of Life change from baseline/post (i.e., time 0/+5 months)

    • Quality of Life in Alzheimer's Disease (Logsdon et al., 1999); The test measure quality of life in dementia. Rating is got from both the participant and the caregiver.

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

  2. Mood Index change from baseline/post (i.e., time 0/+5 months)

    • Cornell Scale for Depression in Dementia (CSDD, Alexopoulos, Abrams, Young, \& Shamoian, 1988); This test is specifically designed to screen depressive symptoms in older adults with dementia and cognitive impairment. It is an interviewer-administered scale relying on information from caregivers and clinician's observations.

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

  3. Neuro-psychiatric symptoms change from baseline/post (i.e., time 0/+5 months)

    • Neuro-Psychiatric Inventory (NPI, Cummings, 1994) A tool that provides information on the presence of psychopathology in people with brain disorders. The NPI was developed for people with Alzheimer's disease and other dementias, but it may be useful in the assessment of behavioural changes in other conditions.

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

  4. Cognitive reserve

    • Cognitive Reserve Index Questionnaire (CRI-Q, Nucci, Mapelli, Mondini, 2012). A tool used to quantify, in a standardized model, cognitive reserve through an interview to the participant or to the caregiver. The questionnaire collects demographic information regarding the school curriculum, work and type of free-time activities. These three different indices (CRI-School, CRI-Work and CRI-Free Time) are then combined into a single "Index of Cognitive Reserve". This test is useful in the research setting to balance study groups, as occur this project.

    Measured: Baseline (i.e., time 0)

  5. Wellbeing of Older People scale

    (WOOP; Hackert et al., 2020) Used as a general index of wellbeing, the scale asks participants to rate nine factors (physical health, mental health, social contacts, support, acceptance and resilience, feeling useful, independence, financial security, and living situation) according to their importance for overall wellbeing. Higher scores reflect greater self-perceived wellbeing

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

  6. Sleep Quality Index

    Measured with the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) to assess overall sleep quality. This self-report questionnaire comprises seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction."

    Measured: Baseline vs. post- intervention period (time 0/+5-months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2021
  2. Study start1 Apr 2022
  3. Primary completion30 Apr 2024
  4. Study completion26 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851028
Sponsor's protocol ID
2020 Dec 14845
Other IDs
DUNHILL MEDICAL TRUST
Acronym
MusiCare
Status last verified
Aug 2025
First submitted
29 Mar 2021
Last updated
3 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: An anonymised dataset will be created with all the cognitive and physiological data collected from participants that will give consent to share their anonymised data.

Publications

  • Brotons M, Koger SM. The impact of music therapy on language functioning in dementia. J Music Ther. 2000 Fall;37(3):183-95. doi: 10.1093/jmt/37.3.183.

    PubMed 10990596

  • Hsu MH, Flowerdew R, Parker M, Fachner J, Odell-Miller H. Individual music therapy for managing neuropsychiatric symptoms for people with dementia and their carers: a cluster randomised controlled feasibility study. BMC Geriatr. 2015 Jul 18;15:84. doi: 10.1186/s12877-015-0082-4.

    PubMed 26183582

  • Zhang Y, Cai J, An L, Hui F, Ren T, Ma H, Zhao Q. Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis. Ageing Res Rev. 2017 May;35:1-11. doi: 10.1016/j.arr.2016.12.003. Epub 2016 Dec 23.

    PubMed 28025173

  • Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available.

    PubMed 6860082

  • Nucci M, Mapelli D, Mondini S. Cognitive Reserve Index questionnaire (CRIq): a new instrument for measuring cognitive reserve. Aging Clin Exp Res. 2012 Jun;24(3):218-26. doi: 10.3275/7800. Epub 2011 Jun 20.

    PubMed 21691143

  • Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.

    PubMed 3337862

  • Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

    PubMed 7991117

  • Di Liberto GM, O'Sullivan JA, Lalor EC. Low-Frequency Cortical Entrainment to Speech Reflects Phoneme-Level Processing. Curr Biol. 2015 Oct 5;25(19):2457-65. doi: 10.1016/j.cub.2015.08.030. Epub 2015 Sep 24.

    PubMed 26412129

  • Di Liberto GM, Pelofi C, Bianco R, Patel P, Mehta AD, Herrero JL, de Cheveigne A, Shamma S, Mesgarani N. Cortical encoding of melodic expectations in human temporal cortex. Elife. 2020 Mar 3;9:e51784. doi: 10.7554/eLife.51784.

    PubMed 32122465

  • Biggio, G. and Mostallino, M.C., 2013. Stress, cortisol, neuronal plasticity, and depressive disorder. Journal of Psychopathology, 19, pp.77-83.

  • Logsdon, R.G., Gibbons, L.E., McCurry, S.M. and Teri, L., 1999. Quality of life in Alzheimer's disease: patient and caregiver reports. Journal of Mental health and Aging, 5, pp.21-32.

  • Arcara, G., Bisiacchi, P. S., Mapelli, D., Mondini, S., & Vestri, A. 2011. Esame Neuropsicologico Breve (ENB-2): una batteria di test per lo screening neuropsicologico, Raffaello Cortina Editore, Milano.

  • Reitan, R. M., & Wolfson, D. (2009). The Halstead-Reitan neuropsychological test battery for adults-theoretical, methodological, and validational bases. Neuropsychological assessment of neuropsychiatric and neuromedical disorders, 1, 3-24.

  • Mangiacotti, A., Cipriani, G., Ward, E., Franco, F. and Biasutti, M., 2019b. The Music Cognitive Test: A new music-based cognitive test. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 15(7), pp.446-P447.

  • Mangiacotti, A., Hsu, M.H., Barone, C., Di Liberto, G., Van Puyvelde, M., Biasutti, M. and Franco, F., 2019a. Effects of music therapy in elderly care: cognition, biomarkers, mood and social behaviour. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 15(7), p.1144.

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy in people with Healthy Aging and Cognitive Impairment, run by Middlesex University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General cognitive functions change from baseline/post (i.e., time 0/+5 months) (time frame: Baseline vs. post- intervention period (time 0/+5-months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04851028, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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