Clinical trial NCT05856604: Music Therapy for Older Adults With Cognitive Decline Living in Care Homes
Official title: Evaluation of Cognitive Effects Generated by Music Therapy for Older Adults With Cognitive Impairment Living in Care Homes - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Cognitive Decline
Keywords: music therapy
aging
cognitive rehabilitation
biomarkers
saliva cortisol/DHEA
Lead sponsor: Middlesex University
Sponsor class: OTHER
Collaborators: name: Methodist Homes for the Aged
First posted: 2023-05-12
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group = Improvisational Music Therapy Active control group = Storytelling activity
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: RESEARCH QUESTIONS

1. - What are the cognitive-neuropsychological benefits of Music Therapy activities in older adults with mild-moderate cognitive impairment?
2. - What are the behavioural-wellbeing benefits of Music Therapy activities in older adults with mild-moderate cognitive impairment?
3. - Can Music Therapy influence the psychophysiological domains (i.e., cortisol/DHEA ratio, RSA) of people with mild-moderate cognitive impairment?

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Music Cognitive Test (MCT)
timeFrame: Change in MCT score from baseline (time 0) to post-intervention period (+4 months).
measure: Cornell Scale for Depression in Dementia (CSDD, Alexopoulos et al., 1988)
timeFrame: Change in CSDD score from baseline (time 0) to post-intervention period (+4 months).
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA, Nasreddine et al., 2005)
timeFrame: Change in MoCa score from baseline (time 0) to post-intervention period (+4 months).
measure: Verbal Fluency test, Phonemic & Semantic (VFT, Ardila et al., 2006; Machado et al., 2009)
timeFrame: Change in VTF score from baseline (time 0) to post-intervention period (+4 months).
measure: Clock Drawing test (CDT, Mondini et al., 2011)
timeFrame: Change in CDT score from baseline (time 0) to post-intervention period (+4 months).
measure: Tangled Figure Test (TFT, in Mondini et al., 2011, adaptation of Rey, 1964)
timeFrame: Change in TFT score from baseline (time 0) to post-intervention period (+4 months).
measure: Trail Making Test (TMT-A, in Mondini et al., 2011)
timeFrame: Change in TMT-A score from baseline (time 0) to post-intervention period (+4 months).
measure: Bristol Activities of Daily Living Scale (BADL, Bucks et al., 1996)
timeFrame: Change in BADL score from baseline (time 0) to post-intervention period (+4 months).
measure: Quality of Life in Alzheimer's Disease (QoL, Logsdon et al., 2002).
timeFrame: Change in QoL score from baseline (time 0) to post-intervention period (+4 months).
measure: The Satisfaction With Life Scale (SWLS, Diener et al., 1985).
timeFrame: Change in SWLS score from baseline (time 0) to post-intervention period (+4 months).
measure: Neuropsychiatric Inventory (NPI, Cummings et al., 1994)
timeFrame: Change in NPI score from baseline (time 0) to post-intervention period (+4 months).
Other outcomes:
measure: Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+4 months)
timeFrame: [Time Frame: Baseline vs. mid vs. post- intervention period (time 0/+2-months/+4months)
measure: RSA change from baseline/post
timeFrame: Baseline and post- intervention period (time 0/+4 months)
Locations:
city: Derby
country: United Kingdom
facility: MHA Methodist Homes
Study officials:
affiliation: Middlesex University
name: Anthony Mangiacotti, PhD
role: PRINCIPAL_INVESTIGATOR
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