Music Therapy for Older Adults With Cognitive Decline Living in Care Homes

NCT05856604 | Completed

• 1 other identifier: ST020-2018
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Impairment; Cognitive Decline

Keywords

music therapy; aging; cognitive rehabilitation; biomarkers; saliva cortisol/DHEA

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (9)

• Montreal Cognitive Assessment (MoCA, Nasreddine et al., 2005)

  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)

  Change in VTF score from baseline (time 0) to post-intervention period (+4 months).

• Clock Drawing test (CDT, Mondini et al., 2011)

  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)

  Change in TFT score from baseline (time 0) to post-intervention period (+4 months).

• Trail Making Test (TMT-A, in Mondini et al., 2011)

  Change in TMT-A score from baseline (time 0) to post-intervention period (+4 months).

Other Outcomes (2)

• Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+4 months)

  [Time Frame: Baseline vs. mid vs. post- intervention period (time 0/+2-months/+4months)

• RSA change from baseline/post

  Baseline and post- intervention period (time 0/+4 months)

Study Arms (2)

Experimental

EXPERIMENTAL

Improvisational Music Therapy - 45min, one 2 one intervention.

Behavioral: Music Therapy

Active Control

ACTIVE COMPARATOR

Storytelling activity - 45min, one 2 one intervention.

Behavioral: Storytelling

Interventions

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).

Experimental

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.

Active Control

Eligibility Criteria

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

You may qualify if:

• Aged ≥60yrs
• No significant hearing impairment that would negatively interfere with the music-based interventions
• Fluent in English
• 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
• Methodist Homes for the Aged: collaborator

Study Sites (1)

MHA Methodist Homes

Derby, DE1 2EQ, United Kingdom

Location

Related Publications (22)

• 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.

  PMID: 30833913 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.

  PMID: 28691506 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.

  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

• 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

  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.

  PMID: 25207803 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

• 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.

  PMID: 15817019 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

  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.

  PMID: 29213611 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

  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.

  PMID: 8670538 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.

  PMID: 12021425 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.

  PMID: 16367493 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

  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

• 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.

  PMID: 22564216 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.

  PMID: 15175425 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.

  PMID: 34030538 BACKGROUND

• 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.

  PMID: 39666490 DERIVED

Related Links

• Aktas, A., \& Keskin, B. (2013). Statistical power analysis. The 7th International Days of Statistics and Economics, 578-587

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental group = Improvisational Music Therapy Active control group = Storytelling activity

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 12, 2023
• Study Start: February 1, 2018
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)