Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults

NCT05447312 | Active Not Recruiting

• 1 other identifier: TMU2022-CAL-Pi-AMT
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress, Psychological; Functional Abilities; Executive Functions; Loneliness; Emotion Regulation; Well Being

Keywords

Older adults; Music therapy; Cognition; Psychosocial; Intervention

Outcome Measures

Primary Outcomes (7)

• 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),

• 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),

Study Arms (3)

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.

Other: Adaptive Music Intervention

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.

Other: Traditional Music Intervention

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.

Interventions

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.

Also known as: Cognitive

Traditional Music Intervention (TM)

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.

Also known as: Cognitive

Adaptive Music Intervention (AM)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• without previous mental health diagnosis;
• with access to a computer and internet;
• with largely normal or corrected to normal hearing;
• without dementia-related cognitive decline (score of 24 or higher on Mini-Mental State Exam)

You may not qualify if:

• with previous mental health diagnosis;
• without access to a computer and internet;
• without largely normal or corrected to normal hearing;
• with dementia-related cognitive decline (score of 23 or lower on Mini-Mental State Exam)
• if participant is an outlier on the cognitive tasks, scoring +/- 2.5 standard deviations on the computerized cognitive tasks.
• if half or more of the psychosocial questionnaires are incomplete.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Mitacs: collaborator

Study Sites (1)

Ryerson University (renamed: Toronto Metropolitan University)

Toronto, Ontario, M5B 2K3, Canada

Location

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MeSH Terms

Conditions

Stress, Psychological; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Kathryn Bolton, BA. hons

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 7, 2022
• Study Start: December 1, 2022
• Primary Completion: November 7, 2025
• Study Completion (Estimated): November 15, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Available in December 2023 for at least 10 years.
• Access Criteria: To be determined.

Locations

CA (1)