Cognitive ImpairmentNCT05856604
Music Therapy for Older Adults With Cognitive Decline Living in Care Homes
A study testing Music Therapy and Storytelling in people with Cognitive Impairment and Cognitive Decline, run by Middlesex University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Cognitive Decline
- What is being tested?
- Music Therapy and Storytelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cognitive Effects Generated by Music Therapy for Older Adults With Cognitive Impairment Living in Care Homes - a Randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Cognitive Impairment, Cognitive Decline
- Being tested
- Music Therapy, Storytelling
- Keywords
- music therapy, aging, cognitive rehabilitation, biomarkers, saliva cortisol/DHEA
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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).
StorytellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Improvisational Music Therapy - 45min, one 2 one intervention. Receives: Behavioral: Music Therapy |
| Active Control | Active comparator | Storytelling activity - 45min, one 2 one intervention. Receives: Behavioral: Storytelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in NPI score from baseline (time 0) to post-intervention period (+4 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Feb 2018
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group = Improvisational Music Therapy Active control group = Storytelling activity
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Middlesex University
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist Homes for the Aged
- Responsible party
- Principal investigator, Anthony Mangiacotti, Middlesex University
- Investigators
- Anthony Mangiacotti, PhD, Principal investigator, Middlesex University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856604
- Sponsor's protocol ID
- ST020-2018
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data have been analysed as group data (e.g., comparing men vs. women) and will be presented in an aggregate form
Publications
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.
PubMed 30833913Fusar-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.
PubMed 28691506Brotons 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.
PubMed 10990596Hsu 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.
PubMed 26183582Zhang 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.
PubMed 28025173Mangiacotti, 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
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.
PubMed 25207803Alexopoulos 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.
PubMed 3337862Nasreddine 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.
PubMed 15817019Ardila, 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
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.
PubMed 29213611ondini, 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.
Rey A (1958). L'examen clinique en psychologie (1st ed.). Paris: Presses universitaires de France
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.
PubMed 8670538Logsdon 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.
PubMed 12021425
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Effects Generated by Music Therapy for Older Adults With Cognitive Impairment Living in Care Homes - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05856604
- Acronym / sponsor ID
- ST020-2018
- Conditions
- Cognitive Impairment, Cognitive Decline
- Keywords
- music therapy, aging, cognitive rehabilitation, biomarkers, saliva cortisol/DHEA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Middlesex UniversityUniversity, hospital or other
- Collaborators
- Methodist Homes for the Aged
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- - 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group = Improvisational Music Therapy Active control group = Storytelling activity
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Music TherapyImprovisational Music Therapy - 45min, one 2 one intervention. |
| Active Control | Active comparator | Behavioral: StorytellingStorytelling activity - 45min, one 2 one intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyWeekly 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). | Behavioural | Experimental |
| StorytellingWeekly 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. | Behavioural | Active Control |
Primary outcome
Music Cognitive Test (MCT)
Time frame: Change in MCT score from baseline (time 0) to post-intervention period (+4 months).
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.
Cornell Scale for Depression in Dementia (CSDD, Alexopoulos et al., 1988)
Time frame: Change in CSDD score from baseline (time 0) to post-intervention period (+4 months).
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.
9 secondary outcomes
Montreal Cognitive Assessment (MoCA, Nasreddine et al., 2005)
Time frame: 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)
Time frame: Change in VTF score from baseline (time 0) to post-intervention period (+4 months).
Clock Drawing test (CDT, Mondini et al., 2011)
Time frame: 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)
Time frame: Change in TFT score from baseline (time 0) to post-intervention period (+4 months).
Trail Making Test (TMT-A, in Mondini et al., 2011)
Time frame: 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)
Time frame: 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).
Time frame: Change in QoL score from baseline (time 0) to post-intervention period (+4 months).
The Satisfaction With Life Scale (SWLS, Diener et al., 1985).
Time frame: Change in SWLS score from baseline (time 0) to post-intervention period (+4 months).
Neuropsychiatric Inventory (NPI, Cummings et al., 1994)
Time frame: Change in NPI score from baseline (time 0) to post-intervention period (+4 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 30833913Kim 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.
- Background: PubMed 28691506Fusar-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.
- Background: PubMed 10990596Brotons 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.
- Background: PubMed 26183582Hsu 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.
- Background: PubMed 28025173Zhang 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.
- BackgroundMangiacotti, 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: PubMed 25207803Van 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.
- Background: PubMed 3337862Alexopoulos 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.
- Background: PubMed 15817019Nasreddine 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.
- BackgroundArdila, 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: PubMed 29213611Machado 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.
- Backgroundondini, 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.
- Aktas, A., \& Keskin, B. (2013). Statistical power analysis. The 7th International Days of Statistics and Economics, 578-587Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Mangiacotti, PhD principal investigator
Middlesex University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy and Storytelling in people with Cognitive Impairment and Cognitive Decline, run by Middlesex University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Music Cognitive Test (MCT) (time frame: Change in MCT score from baseline (time 0) to post-intervention period (+4 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05856604, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.