Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults
NCT ID: NCT05447312
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
75 participants
INTERVENTIONAL
2022-12-01
2026-11-15
Brief Summary
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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.
Detailed Description
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1. to further assess the benefits of traditional music interventions (TM) in older adults
2. to assess the additional benefits of the Pi Electronics adaptive music intervention (AM) as compared to TM in older adults
3. to assess the long-term durability over a 3-month period of the training benefits, if any
4. to validate Pi's real-time EEG headset and corresponding speaker for future therapeutic use.
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:
* 1st-2nd: Research Ethics Board Approval
* 2nd-3rd: Design and testing preparation
* 2nd-6th: Research Assistant training; participant recruitment
* 3rd-9th: Data collection and validation
* 8th-11th: Data analysis
* 10th-12th: Knowledge dissemination
* 12th: Mitacs final report and survey
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Adaptive Music Intervention (AM)
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.
Adaptive Music Intervention
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.
Traditional Music Intervention (TM)
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.
Traditional Music Intervention
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.
Control Group
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.
No interventions assigned to this group
Interventions
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Adaptive Music Intervention
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.
Traditional Music Intervention
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. with access to a computer and internet;
3. with largely normal or corrected to normal hearing;
4. without dementia-related cognitive decline (score of 24 or higher on Mini-Mental State Exam)
Exclusion Criteria
2. without access to a computer and internet;
3. without largely normal or corrected to normal hearing;
4. with dementia-related cognitive decline (score of 23 or lower on Mini-Mental State Exam)
5. if participant is an outlier on the cognitive tasks, scoring +/- 2.5 standard deviations on the computerized cognitive tasks.
6. if half or more of the psychosocial questionnaires are incomplete.
65 Years
ALL
Yes
Sponsors
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Mitacs
INDUSTRY
Toronto Metropolitan University
OTHER
Responsible Party
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Kathryn Bolton
Graduate Student
Principal Investigators
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Kathryn Bolton, BA. hons
Role: PRINCIPAL_INVESTIGATOR
Toronto Metropolitan University
Locations
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Ryerson University (renamed: Toronto Metropolitan University)
Toronto, Ontario, Canada
Countries
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References
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Other Identifiers
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TMU2022-CAL-Pi-AMT
Identifier Type: -
Identifier Source: org_study_id