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| ID | Type | Description | Link |
|---|---|---|---|
| DUNHILL MEDICAL TRUST | Other Grant/Funding Number | RPGF2006\241 |
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| Name | Class |
|---|---|
| The Dunhill Medical Trust | OTHER |
| University of Padova | OTHER |
| Vrije Universiteit Brussel | OTHER |
| University of Dublin, Trinity College |
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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.
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\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One2One | Experimental | 1) Weekly individual (one2one) Music Therapy intervention lasting 5 months (n=20 sessions) |
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| Small-group | Experimental | 2) Weekly small group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions) |
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| Large group | Experimental | 3) Weekly Large group (max 8 people per group) Music Therapy intervention lasting 5 months (n=20 sessions) |
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| Control | No Intervention | Passive control, not attending any music-related activity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline vs. post- intervention period (time 0/+5-months) |
| Mood Index change from baseline/post (i.e., time 0/+5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+5 months) | Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Mangiacotti, PhD | Middlesex University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHA Methodist Homes | Derby | DE1 2EQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10990596 | Background | 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. | |
| 26183582 | 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. |
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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.
August 2025
Middlesex University FigShare
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| OTHER |
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• 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. |
| Baseline vs. post- intervention period (time 0/+5-months) |
| 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. | Baseline vs. post- intervention period (time 0/+5-months) |
| 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. | Baseline (i.e., time 0) |
| 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 | Baseline vs. post- intervention period (time 0/+5-months) |
| 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." | Baseline vs. post- intervention period (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) | Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant:
| 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) | Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Biggio, Mostallino 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory). The cortisol/DHEA ratio can be considered a reliable stress index.The average of three daily collections will be performed to obtain a single daily value. Three passive-drool samples are collected in a single day for each participant:
| Mid-intervention period (10 weeks) vs. post-intervention (5 months) |
| RSA change from baseline/post (i.e., time 0/+5 months) | • Respiratory sinus arrhythmia (RSA): 5 min resting state | Baseline and post- intervention period (time 0/+5-months) |
| EEG change from baseline/post (i.e., time 0/+5 months) | • Neural tracking of natural speech and musical sound: EEG measures of cortical activity (Di Liberto et al., 2015, 2020) - 8 electrodes, 15 minutes. | Baseline and post- intervention period (time 0/+5-months) |
| 28025173 | 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. |
| 6860082 | 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. |
| 21691143 | 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. |
| 3337862 | 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. |
| 7991117 | 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. |
| 26412129 | 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. |
| 32122465 | 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. |
| 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). |
| 42161569 | Derived | Mangiacotti A, Ward EV, Williams S, Barone C, Ataye K, Asue ML, Behram A, Hsu MH, Lovato E, Zandona A, Franco F. A randomized controlled trial comparison of three music therapy formats on cognitive function and psychological well-being in normal aging. J Gerontol B Psychol Sci Soc Sci. 2026 May 7;81(6):gbag070. doi: 10.1093/geronb/gbag070. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |