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| Name | Class |
|---|---|
| Methodist Homes for the Aged | OTHER |
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This research aims to investigate whether the use of music-improvisation therapy for older adult participants can lead to improvements in cognitive ability levels, especially in attentional functions. Very relevant reviews highlight studies that demonstrate the effectiveness of Music Therapy training. However, only a few are based on randomised criteria and structured methodological approaches. This affects the generalizability of findings, as to whether Music Therapy interventions are effective in improving cognitive functions, mood, and quality of life of people with cognitive decline.
In order to make a difference, there is a need for more studies that are structured [i] according to rigorous empirical criteria (namely involving random assignment of participants to activity groups), [ii] and that gather scientific evidence, based on both standardized cognitive tests and biomarkers (hormones: Cortisol, or stress hormone, and DHEA or aging hormone; brain signal, EEG; Physiology: Respiratory Sinus Arrhythmia).
In this RCT study, the investigator investigated the effect of 4-month music therapy vs Storytelling program for older adults with cognitive decline, living in care homes.
RESEARCH QUESTIONS
Participants A power sample size calculation with an effect size (f) = 0.26, α= 0.05, Power (1-β) = 0.80 (any level over 0.80 is considered satisfactory) was performed with G*Power software yielding an overall n=32 minimum participant sample.
Participants were randomly allocated by a blind researcher to a MT (experimental group) or a ST intervention (active control group) using a computerised randomisation method.
To minimise a possible drop-out rate with a consequent loss of power, a total of 50 participants were recruited, of which 42 completed the study, 23 in the experimental group and 19 in the control group. All participants underwent a neuropsychological test battery examination. No baseline differences were found between the experimental and control group as to screening demographic variables, MMSE, Cognitive Reserve and a battery of cognitive and behavioural tests. Hence the two groups were equivalent at the start of the study.
DATA ANALYSIS Data of the neuropsychological, well-being and biomarker measures were analysed using a mixed design ANOVA with time (pre-post intervention) as a within-subject factor and group (MT vs ST) as a between-subjects factor. The dependent variables were the cognitive, neuropsychological test and biomarkers tests. Quantitative data were processed using IBM SPSS Statistic 25. Partial eta-square (ηp²) and Cohen's d were used as a measure of effect size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Improvisational Music Therapy - 45min, one 2 one intervention. |
|
| Active Control | Active Comparator | Storytelling activity - 45min, one 2 one intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy | Behavioral | Weekly individual (one2one) Music Therapy intervention lasting 4 months (n=16 sessions). Behavioral: Music Therapy 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 been 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 |
|---|---|---|
| Music Cognitive Test (MCT) | The Music Cognitive Test (Mangiacotti et al., 2022) which is a music-based cognitive screening test, specifically designed to measure possible changes brought by music-based interventions. The score range is 0-52 points; A higher score indicates better cognitive performance, with a score of 45 or above considered normal cognitive functioning. | Change in MCT score from baseline (time 0) to post-intervention period (+4 months). |
| Cornell Scale for Depression in Dementia (CSDD, Alexopoulos et al., 1988) | The Cornell Scale for Depression in Dementia (CSDD) is a test to screen depressive symptoms in older adults with dementia and cognitive impairment. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The score range is 0-38 with scores above 10 indicating a probable major depression. Scores above 18 indicate a definite major depression. | Change in CSDD score from baseline (time 0) to post-intervention period (+4 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA, Nasreddine et al., 2005) | The Montreal Cognitive Assessment (MoCA) is a brief extensively validated screening tool to measure cognitive impairment and is widely used in both clinical and experimental settings. The score range is 0-30 points; A higher score indicates better cognitive performance with a score of 26 or above considered normal cognitive functioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+4 months) | Two types of salivary hormones will be collected: 1) Cortisol, which is associated with emotional distress and depressive symptoms (Herbert, 2013); 2) DHEA is an age-related hormone involved in different physiological mechanisms (anti-oxidant, anti-inflammatory; Kurata et al., 2004). The cortisol/DHEA ratio can be considered a reliable stress index (Theorell et al., 2021). The average of four daily collections will be performed to obtain a single daily value. Four 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHA Methodist Homes | Derby | DE1 2EQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30833913 | Background | Kim SJ, Yoo GE. Instrument Playing as a Cognitive Intervention Task for Older Adults: A Systematic Review and Meta-Analysis. Front Psychol. 2019 Feb 18;10:151. doi: 10.3389/fpsyg.2019.00151. eCollection 2019. | |
| 28691506 | Background | Fusar-Poli L, Bieleninik L, Brondino N, Chen XJ, Gold C. The effect of music therapy on cognitive functions in patients with dementia: a systematic review and meta-analysis. Aging Ment Health. 2018 Sep;22(9):1097-1106. doi: 10.1080/13607863.2017.1348474. Epub 2017 Jul 10. |
| Label | URL |
|---|---|
| Aktas, A., \& Keskin, B. (2013). Statistical power analysis. The 7th International Days of Statistics and Economics, 578-587 | View source |
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the data have been analysed as group data (e.g., comparing men vs. women) and will be presented in an aggregate form
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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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Experimental group = Improvisational Music Therapy Active control group = Storytelling activity
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| Storytelling | Behavioral | Weekly individual (one2one) Storytelling intervention lasting 4 months (n=16 sessions). Behavioural: Storytelling is a non-pharmacological activity, in which a professional activity coordinator reads different stories (e.g., poems, novels) to the participants and used them to initiate a possible conversation. |
|
| Change in MoCa score from baseline (time 0) to post-intervention period (+4 months). |
| Verbal Fluency test, Phonemic & Semantic (VFT, Ardila et al., 2006; Machado et al., 2009) | The Verbal Fluency test (VTF) is used to investigate lexical skills, semantic verbal fluency as well as the ability to organize an adequate research strategy. The total score for VFT is made by counting up the total number of animals (for the Semantic part) or words (for the Phonemic part) that the individual is able to produce. A higher score indicates better cognitive performance. | Change in VTF score from baseline (time 0) to post-intervention period (+4 months). |
| Clock Drawing test (CDT, Mondini et al., 2011) | The Clock Drawing test (CDT) is used to evaluate praxis abilities, mental representation and planning abilities. The score range for CDT is 0-10 points with a higher score indicating better cognitive performance. | Change in CDT score from baseline (time 0) to post-intervention period (+4 months). |
| Tangled Figure Test (TFT, in Mondini et al., 2011, adaptation of Rey, 1964) | The Tangle Figure Test (TFT) provides information on spatial-cognitive abilities and executive and naming difficulties. The score range for TFT is 0-50 with a higher score indicating better cognitive performance. | Change in TFT score from baseline (time 0) to post-intervention period (+4 months). |
| Trail Making Test (TMT-A, in Mondini et al., 2011) | The Trail Making Test-A (TMT-A) assess selective attention and psychomotor speed. The test is scored based on how many seconds it takes the participant to complete the trial. Higher scores indicate a higher degree of cognitive impairment. | Change in TMT-A score from baseline (time 0) to post-intervention period (+4 months). |
| Bristol Activities of Daily Living Scale (BADL, Bucks et al., 1996) | The Bristol Activities of Daily Living is a scale developed to measure activities of daily living (ADL) specifically designed for individuals with mild dementia living in a care home setting. The score range is 0-60, with a higher score indicating a higher degree of dependence on ADL. | Change in BADL score from baseline (time 0) to post-intervention period (+4 months). |
| Quality of Life in Alzheimer's Disease (QoL, Logsdon et al., 2002). | The Quality of Life in Alzheimer's Disease (QoL) measures the quality of life in dementia. QoL is measured using the 13-item scale. Total score range from 13-52; higher scores indicate better quality of life. | Change in QoL score from baseline (time 0) to post-intervention period (+4 months). |
| The Satisfaction With Life Scale (SWLS, Diener et al., 1985). | The Satisfaction With Life Scale (SWLS) is a widely used 5-item measure of global life satisfaction and showed sufficient sensitivity to be a potentially valuable tool to detect changes in life satisfaction during clinical interventions (Pavot & Diener, 2009). The scale is a 7-point Likert-style response scale. The possible range of scores is 5-35 points. | Change in SWLS score from baseline (time 0) to post-intervention period (+4 months). |
| Neuropsychiatric Inventory (NPI, Cummings et al., 1994) | The Neuropsychiatric Inventory is a tool that provides information on behavioral symptoms commonly encountered in people with brain disorders. The total range score is 0-144 with a higher score indicating severe neuropsychiatric symptoms. | Change in NPI score from baseline (time 0) to post-intervention period (+4 months). |
| [Time Frame: Baseline vs. mid vs. post- intervention period (time 0/+2-months/+4months) |
| RSA change from baseline/post | • Respiratory sinus arrhythmia (RSA): 5 min resting state based on Puyvelde et al., (2014) | Baseline and post- intervention period (time 0/+4 months) |
| 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. |
| 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. |
| Background | Mangiacotti, A., Cipriani, G., Ward, E., Franco, F., & Biasutti, M. (2022). Development and validation of the Music Cognitive Test: A music-based cognitive screening test. Psychology of Music, 030573562211008. https://doi.org/10.1177/03057356221100851 |
| 25207803 | Background | Van Puyvelde M, Loots G, Vanfleteren P, Meys J, Simcock D, Pattyn N. Do you hear the same? Cardiorespiratory responses between mothers and infants during tonal and atonal music. PLoS One. 2014 Sep 10;9(9):e106920. doi: 10.1371/journal.pone.0106920. eCollection 2014. |
| 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. |
| 15817019 | Background | Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. |
| Background | Ardila, A., Ostrosky-Solís, F., & Bernal, B. (2006). Cognitive testing toward the future: The example of Semantic Verbal Fluency (ANIMALS). International Journal of Psychology, 41(5), 324-332. https://doi.org/10.1080/00207590500345542 |
| 29213611 | Background | Machado TH, Fichman HC, Santos EL, Carvalho VA, Fialho PP, Koenig AM, Fernandes CS, Lourenco RA, Paradela EMP, Caramelli P. Normative data for healthy elderly on the phonemic verbal fluency task - FAS. Dement Neuropsychol. 2009 Jan-Mar;3(1):55-60. doi: 10.1590/S1980-57642009DN30100011. |
| Background | ondini, S., Mapelli, D., Vestri, A., & Bisiacchi, P. S. (2011). Esame neuropsicologico breve 2: Una batteria di test per lo screening neuropsicologico. [A battery of tests for neuropsychological screening]. Raffaello Cortina Editore. |
| Background | Rey A (1958). L'examen clinique en psychologie (1st ed.). Paris: Presses universitaires de France |
| 8670538 | Background | Bucks RS, Ashworth DL, Wilcock GK, Siegfried K. Assessment of activities of daily living in dementia: development of the Bristol Activities of Daily Living Scale. Age Ageing. 1996 Mar;25(2):113-20. doi: 10.1093/ageing/25.2.113. |
| 12021425 | Background | Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016. |
| 16367493 | Background | Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13. |
| Background | Pavot, W., & Diener, E. (2009). Review of the Satisfaction With Life Scale (pp. 101-117). https://doi.org/10.1007/978-90-481-2354-4_5 |
| 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. |
| 22564216 | Background | Herbert J. Cortisol and depression: three questions for psychiatry. Psychol Med. 2013 Mar;43(3):449-69. doi: 10.1017/S0033291712000955. Epub 2012 May 8. |
| 15175425 | Background | Kurata K, Takebayashi M, Morinobu S, Yamawaki S. beta-estradiol, dehydroepiandrosterone, and dehydroepiandrosterone sulfate protect against N-methyl-D-aspartate-induced neurotoxicity in rat hippocampal neurons by different mechanisms. J Pharmacol Exp Ther. 2004 Oct;311(1):237-45. doi: 10.1124/jpet.104.067629. Epub 2004 Jun 2. |
| 34030538 | Background | Theorell T, Engstrom G, Hallinder H, Lennartsson AK, Kowalski J, Emami A. The use of saliva steroids (cortisol and DHEA-s) as biomarkers of changing stress levels in people with dementia and their caregivers: A pilot study. Sci Prog. 2021 Apr-Jun;104(2):368504211019856. doi: 10.1177/00368504211019856. |
| 39666490 | Derived | Mangiacotti AMA, Hsu MH, Barone C, Van Puyvelde M, Zandona A, Gabai G, Biasutti M, Franco F. Effects of one-to-one music therapy in older adults with cognitive impairment: A randomized controlled trial. Psychol Aging. 2024 Dec;39(8):960-982. doi: 10.1037/pag0000861. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |