MusiCare: Music Therapy & Innovative Technology

NCT04851028 | Completed

• 2 other identifiers: 2020 Dec 14845DUNHILL MEDICAL TRUST
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Healthy Aging; Cognitive Impairment

Keywords

music therapy; aging; cognitive function; robotics

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (6)

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

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

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

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

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

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

• Cognitive reserve

  Baseline (i.e., time 0)

• Wellbeing of Older People scale

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

Other Outcomes (5)

• Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+5 months)

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

• Salivary Hormones index (cortisol/DHEA ratio) change from baseline/mid-intervention(i.e., time 0/+10 weeks)

  Baseline vs. mid-intervention period (time 0/+10 weeks)

• Salivary Hormones index (cortisol/DHEA ratio) change from mid-/post-intervention (i.e., 10weeks/5 months)

  Mid-intervention period (10 weeks) vs. post-intervention (5 months)

Study Arms (4)

One2One

EXPERIMENTAL

1\) Weekly individual (one2one) Music Therapy intervention lasting 5 months (n=20 sessions)

Behavioral: Music Therapy

Small-group

EXPERIMENTAL

2\) Weekly small group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)

Behavioral: Music Therapy

Large group

EXPERIMENTAL

3\) Weekly Large group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions)

Behavioral: Music Therapy

Control

NO INTERVENTION

Passive control, not attending any music-related activity

Interventions

Music Therapy BEHAVIORAL

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).

Large group; One2One; Small-group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Middlesex University: lead
• The Dunhill Medical Trust: collaborator
• University of Padova: collaborator
• Vrije Universiteit Brussel: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

MHA Methodist Homes

Derby, DE1 2EQ, United Kingdom

Location

Related Publications (16)

• 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.

  PMID: 10990596 BACKGROUND

• 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.

  PMID: 26183582 BACKGROUND

• 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.

  PMID: 28025173 BACKGROUND

• 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.

  PMID: 6860082 BACKGROUND

• 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.

  PMID: 21691143 BACKGROUND

• 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.

  PMID: 3337862 BACKGROUND

• 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.

  PMID: 7991117 BACKGROUND

• 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.

  PMID: 26412129 BACKGROUND

• 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.

  PMID: 32122465 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Mangiacotti, A., PhD Thesis, "The Music Cognitive Test validation, training and applicability of a music-based cognitive tool for music therapists - an interdisciplinary study" University of Padua (submitted October 2019 - Viva passed 9th March 2020).

  BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Anthony Mangiacotti, PhD

  Middlesex University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Psychology; Co-PI MusiCare Project

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 20, 2021
• Study Start: April 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: May 26, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: August 2025
• Access Criteria: Middlesex University FigShare

Locations

GB (1)