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| Name | Class |
|---|---|
| Mitacs | INDUSTRY |
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The proposed study is a pilot study that aims to understand if the Pi Electronics adaptive music intervention (AM) is effective to promote positive psychosocial and cognitive outcomes, over and above a traditional music intervention (TM) among healthy older adults. This study will contribute to the ongoing literature on the benefits of music interventions and provide insight on how emerging technology can enhance the therapeutic effects of music as a viable intervention for older adults.
The study will adopt a three-arm randomized controlled trial (RCT). Eligible participants will be randomized into one of three groups: traditional music therapy group (TM), Pi Electronic's adaptive music program (AM), and a waitlist control group (CG). Informed consent will be collected from all participants. All three groups will complete outcome measures at three sessions: pretest, posttest, and at a three-month follow-up, but only the TM and AM group will receive music between the pretest and posttest sessions, spanning for 4 weeks, with 4 music therapy sessions per week, and each session lasting 30 minutes.
Data will be analyzed for each outcome variables to understand the group differences in the performance on the psychosocial and cognitive outcome measures. The study will also validate the Pi Electronics EEG headset with the BioSemi, 64-channel EEG system.
Objectives:
Sample: healthy older adults (65 years and older) will be recruited from the Ryerson Seniors Participants Pool (RSPP) and through community advertising. The target sample size will be 75 participants (N = 25 per group), evenly randomized into the three arms of intervention: TMT, AIT, and no-treatment waitlist control group (CG).
Overall Design and Procedure: informed consent will be collected. All groups will complete behavioural and neurophysiological outcome assessments at three time-points: pretest, posttest, and 3-month follow-up. EEG and mood validation will be conducted at pretest for the AIT group. During this procedure, participants will be exposed to default music database to induce the target mood while EEG is recorded and mood regulation is monitored (e.g., Sourina et al., 2012). Participants will be asked to self-rate their positive emotional valence (happy and calm) by completing the Positive and Negative Affect Schedule (Watson, et al., 1988). Participants in the intervention groups will be given instructions on their respective intervention program to ensure they are fully familiarized.
Intervention: the TM and AM groups will span for 4 weeks, requiring engagement in at least four 30-minute sessions of music listening per week, delivered on-line through cloud from the Pi Speakers. The AM and TM group will be exposed to individually selected music pieces based on the data collected at pretest. However, the AM group will be exposed to music that has been enhanced by frequencies that elicit positive mood in participants.
Data Analysis Plan: To understand the training benefits, a three group by two time (pretest versus posttest), mixed model analysis of variance (ANOVA) will be employed. This will be done to understand the differences in the psychosocial and cognitive outcome variables within and between subjects from before to after the music program training. To understand the maintenance effect, a three group by two time (posttest versus three-month follow-up) mixed model ANOVA will be employed. Again, this will be used to understand if there are significant differences in training benefit maintenance for the psychosocial and cognitive outcome variables, both between and within subjects in the TM, AM, and CG. The study will also validate the Pi Electronics EEG headset with the BioSemi, 64-channel EEG system by comparing the mean peak difference of average waveforms of event related potentials using t-tests.
Timeline:
1-year period starting in 2022, outlined below in months:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Music Intervention (AM) | Experimental | The intervention will be an adaptive music program, in which participants will listen to music provided by the research team that has been enhanced with frequencies that elicit positive moods using the Pi Electronic Venus speaker for 30 minutes, at least 4 times in a week over 4 weeks. |
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| Traditional Music Intervention (TM) | Active Comparator | The intervention will be traditional music therapy, in which participants will listen to music provided by the research team that has not been enhanced with frequencies using the Pi Electronic Venus speaker for 30 minutes, at least 4 times in a week over 4 weeks. |
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| Control Group | No Intervention | The control intervention will be an audiobook provided by the research team that participants will listen to using the Pi Electronic Venus speaker for 30 minutes, at least 4 times in a week over 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Music Intervention | Other | Music that has been enhanced by frequencies that are associated with positive feelings as measured by EEG data. Music will be delivered through the Pi Electronic Inc.'s Venus Speaker that aims to promote psychosocial and cognitive functioning over and above traditional music therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life: Psychosocial functions of healthy older adults. | All computerized on Qualtrics, no cut off scores. Psychosocial functioning will be assessed using the: -World Health Organization - 5. Higher scores indicate increased quality of life. | Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), |
| Resiliency: Psychosocial functions of healthy older adults. | All computerized on Qualtrics, no cut off scores. Psychosocial functioning will be assessed using the: -Brief Resilient Coping Scale. Higher scores indicates higher resiliency coping. | Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), |
| Emotional Regulation: Psychosocial functions of healthy older adults. | All computerized on Qualtrics, no cut off scores. Psychosocial functioning will be assessed using the: -Emotion Regulation Questionnaire. Higher scores indicate increased emotional regulation. | Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), |
| Activities of Daily Living: Psychosocial functions of healthy older adults. | All computerized on Qualtrics, no cut off scores. Psychosocial functioning will be assessed using the: -Lawton Instrumental Activities of Daily Living Scale. Higher scores indicate better everyday functioning. | Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), |
| Loneliness: Psychosocial functions of healthy older adults. | All computerized on Qualtrics, no cut off scores. Psychosocial functioning will be assessed using the: - 6-item de Jong Gierveld. Higher scores indicate increased loneliness. | Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Bolton, BA. hons | Toronto Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryerson University (renamed: Toronto Metropolitan University) | Toronto | Ontario | M5B 2K3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10916193 | Background | Cahn-Weiner DA, Malloy PF, Boyle PA, Marran M, Salloway S. Prediction of functional status from neuropsychological tests in community-dwelling elderly individuals. Clin Neuropsychol. 2000 May;14(2):187-95. doi: 10.1076/1385-4046(200005)14:2;1-Z;FT187. | |
| 27405091 | Background | Ben-Haim MS, Williams P, Howard Z, Mama Y, Eidels A, Algom D. The Emotional Stroop Task: Assessing Cognitive Performance under Exposure to Emotional Content. J Vis Exp. 2016 Jun 29;(112):53720. doi: 10.3791/53720. |
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De-identified, collective group information (i.e., aggregate data) will be reported. However, individual scores (i.e., raw data) will not be shared. This may be shared through open science framework.
Available in December 2023 for at least 10 years.
To be determined.
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Three-arm, randomized control trial for psychosocial and cognitive intervention. Participants will be in one of three groups: those receiving music enhanced with frequencies, those receiving music without enhancement, and a waitlist control receiving no intervention.
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Participants in two arms (traditional music intervention and adaptive music intevention groups) will not know which arm of the intervention they will be receiving until after the intervention period has been completed. This is to control for potential response bias in participants on the psychosocial outcome measures and/or the placebo effect.
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| Traditional Music Intervention | Other | Music that has not been enhanced by frequencies. Music is delivered through the Pi Electronic Inc.'s Venus Speaker that aims to promote psychosocial and cognitive functioning. |
|
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| Emotional processing: Cognitive functions of healthy older adults. | All computerized on PsychoPy. Cognitive performance will be measured using the: -Emotional Stroop Task. Increased reaction time to negative emotional words indicates decreased mood. | Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), |
| Processing Speed: Cognitive functions of healthy older adults. | All computerized on PsychoPy. Cognitive performance will be measured using the: -Digit Symbol Substitution Test. Increased accuracy indicates better processing speed efficiency. | Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up), |
| Background | Creech, A., Hallam, S., McQueen, H., & Varvarigou, M. (2013). The power of music in the lives of older adults. Research Studies in Music Education, 35(1), 87-102. https://doi.org/10.1177/1321103X13478862 |
| 28149509 | Background | Fang R, Ye S, Huangfu J, Calimag DP. Music therapy is a potential intervention for cognition of Alzheimer's Disease: a mini-review. Transl Neurodegener. 2017 Jan 25;6:2. doi: 10.1186/s40035-017-0073-9. eCollection 2017. |
| Background | Gierveld JDJ, Tilburg TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness: Confirmatory Tests on Survey Data. Res Aging. 2006;28(5):582-598. doi:10.1177/0164027506289723 |
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| Background | Sourina, O., Liu, Y., & Nguyen, M. K. (2012). Real-time EEG-based emotion recognition for music therapy. Journal on Multimodal User Interfaces, 5(1-2), 27-35. https://doi.org/10.1007/s12193-011-0080-6 |
| 15842075 | Background | Thompson RG, Moulin CJ, Hayre S, Jones RW. Music enhances category fluency in healthy older adults and Alzheimer's disease patients. Exp Aging Res. 2005 Jan-Mar;31(1):91-9. doi: 10.1080/03610730590882819. |
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| Background | World Health Organization. (1998). Wellbeing Measures in Primary Healthcare: The Depcare Project. https://www.euro.who.int/__data/assets/pdf_file/0016/130750/E60246.pdf |
| 27094452 | Background | Zhao K, Bai ZG, Bo A, Chi I. A systematic review and meta-analysis of music therapy for the older adults with depression. Int J Geriatr Psychiatry. 2016 Nov;31(11):1188-1198. doi: 10.1002/gps.4494. Epub 2016 Apr 19. |
| Background | Benedict, R. H. B., Schretlen, D., Groninger, L., & Brandt, J. (1998). Hopkins verbal learning test - Revised: Normative data and analysis of inter-form and test-retest reliability. Clinical Neuropsychologist, 12(1), 43-55. https://doi.org/10.1076/clin.12.1.43.1726 |
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| 35206924 | Background | Gonzalez-Ojea MJ, Dominguez-Lloria S, Pino-Juste M. Can Music Therapy Improve the Quality of Life of Institutionalized Elderly People? Healthcare (Basel). 2022 Feb 6;10(2):310. doi: 10.3390/healthcare10020310. |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
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