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

Study Overview
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Brief Summary
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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.

Detailed Description
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RESEARCH QUESTIONS - What are the cognitive-neuropsychological benefits of Music Therapy activities in older adults with mild-moderate cognitive impairment? - What are the behavioural-wellbeing benefits of Music Therapy activities in older adults with mild-moderate cognitive impairment? - 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.

Official Title
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Evaluation of Cognitive Effects Generated by Music Therapy for Older Adults With Cognitive Impairment Living in Care Homes - a Randomized Control Trial

Conditions
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Cognitive Impairment, Cognitive Decline

Intervention / Treatment
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* Behavioral: Music Therapy
* Behavioral: Storytelling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group = Improvisational Music Therapy Active control group = Storytelling activity
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Improvisational Music Therapy - 45min, one 2 one intervention. | Behavioral: Music Therapy<br>* 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).<br>|
| Active Comparator: Active Control<br>Storytelling activity - 45min, one 2 one intervention. | Behavioral: Storytelling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, aging, cognitive rehabilitation, biomarkers, saliva cortisol/DHEA