Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults (AMT)

December 17, 2025 updated by: Kathryn Bolton, Toronto Metropolitan University

The Effects of an Adaptive Music Program on Psychosocial and Cognitive Functions of Older Adults: a Pilot and Validation Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  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

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • Ryerson University (renamed: Toronto Metropolitan University)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. without previous mental health diagnosis;
  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:

  1. with previous mental health diagnosis;
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • Cognitive
Active Comparator: 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.
Other: 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 Names:
  • Cognitive
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life: Psychosocial functions of healthy older adults.
Time Frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

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.
Time Frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

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.
Time Frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

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.
Time Frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

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.
Time Frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

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),
Emotional processing: Cognitive functions of healthy older adults.
Time Frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

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.
Time Frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

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),

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toronto Metropolitan University

Collaborators

Mitacs

Investigators

  • Principal Investigator: Kathryn Bolton, BA. hons, Toronto Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

November 7, 2025

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

July 1, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU2022-CAL-Pi-AMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Available in December 2023 for at least 10 years.

IPD Sharing Access Criteria

To be determined.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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