An interventional study of Music Therapy and Storytelling in Cognitive Impairment and Cognitive Decline, sponsored by Middlesex University. Completed at 1 site in United Kingdom. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by Middlesex University · Not applicable, Interventional, and Supportive care
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Among 137 studies in Cognitive Dysfunction with a site in United Kingdom — 36 open to participants now, 53 under way, 7 of them phase 3. Cognitive Dysfunction · United Kingdom.
Among the 137 studies in Cognitive Dysfunction with a site in United Kingdom, this one is the 58th largest by enrollment of the 88 interventional ones that give a count, is one of 11 that started in 2018, is one of 50 with no phase, and was the 94th registered.
3,876 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →36 of the 137 studies in Cognitive Dysfunction with a site in United Kingdom are open now. Recruiting first, the newest first:
University College, London · Sites in United Kingdom
Ages 55+
University of Edinburgh · Sites in United Kingdom
Ages 18+
University of Ulster · Sites in United Kingdom
Ages 50+ · Healthy volunteers
Prima Mente · Sites in United Kingdom
Ages 50+
King's College Hospital NHS Trust · Sites in United Kingdom
Ages 18–65
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 753 Cognitive Dysfunction studies recruiting now, 364 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 260 take healthy volunteers.
This study: 65 Years and older · all sexes · healthy volunteers too.
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137 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 17 · Phase 3 14 · Phase 4 1
First in 2004; this study’s year is marked. 11 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 42 is below the median of 64 across 2,797 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 69 across the 88 interventional studies, 100 across the 49 observational. Of the 71 that completed or were terminated, 20 (28%) have results posted.
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44 of 137 have an industry lead sponsor. The 10 most frequent:
Middlesex University is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Middlesex University has 2 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
8 of the studies in Cognitive Dysfunction with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06207942Region SkaneStepcare Extended Follow-up Substudy | 2027-01 |
| NCT03507257Indiana UniversityLongitudinal Early-onset Alzheimer's Disease Study Protocol | 2027-01-01 |
| NCT06604104University of EdinburghVisual Frailty in Ageing | 2027-01-11 |
| NCT07466446University of EdinburghPost Intensive Care Accelerometery to Study and Support Recovery Outcomes | 2027-02-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 137 studies in Cognitive Dysfunction with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Improvisational Music Therapy - 45min, one 2 one intervention.
Behavioral: Music Therapy
Storytelling activity - 45min, one 2 one intervention.
Behavioral: Storytelling
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).
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.
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.
Time frame: 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.
Time frame: Change in CSDD score from baseline (time 0) to post-intervention period (+4 months).
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.
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)
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.
Time frame: 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.
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)
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.
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)
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.
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)
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.
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).
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.
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).
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.
Time frame: 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.
Time frame: Change in NPI score from baseline (time 0) to post-intervention period (+4 months).
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: * At awakening (7am - 8am) * Before lunchtime (11.00am to 12.30am); * Before dinner (4pm to 5pm); * Evening (from 7pm to 8pm).
Time frame: [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)
Time frame: Baseline and post- intervention period (time 0/+4 months)
Plan to share: No — the data have been analysed as group data (e.g., comparing men vs. women) and will be presented in an aggregate form
Ran from Feb 2018 to primary completion in Aug 2019, 18 months.
Of 1,449 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 18 months is below that.
Counting every sponsor, half of 1,518 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Middlesex University