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Stress, PsychologicalAMTNCT05447312

Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults

A study testing Adaptive Music Intervention and Traditional Music Intervention in people with Stress, Psychological and Executive Functions, run by Toronto Metropolitan University at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Adaptive Music Intervention and Traditional Music Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteCanada
Study dates
1 Dec 2022to 15 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Ryerson University (renamed: Toronto Metropolitan University)

    Toronto, Ontario, M5B 2K3

Other trials in Canada

About this study

Official title: 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.

Read the 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
Being tested
Adaptive Music Intervention, Traditional Music Intervention
Keywords
Older adults, Music therapy, Cognition, Psychosocial, Intervention
Medical subject headings
Stress, Psychological, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptive Music InterventionOther

    Also called Cognitive

    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 InterventionOther

    Also called Cognitive

    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.

Study groups in NCT05447312
Study groupRoleWhat they receive
Adaptive Music Intervention (AM)ExperimentalThe 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.
Receives: Other: Adaptive Music Intervention
Traditional Music Intervention (TM)Active comparatorThe 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.
Receives: Other: Traditional Music Intervention
Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start1 Dec 2022
  3. Primary completion7 Nov 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05447312
Sponsor's protocol ID
TMU2022-CAL-Pi-AMT
Acronym
AMT
Status last verified
Sep 2026
First submitted
24 Jun 2022
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 10916193

  • 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.

    PubMed 27405091

  • 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

  • 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.

    PubMed 28149509

  • 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

  • Grenier AS, Lafontaine L, Sharp A. Use of Music Therapy as an Audiological Rehabilitation Tool in the Elderly Population: A Mini-Review. Front Neurosci. 2021 Sep 16;15:662087. doi: 10.3389/fnins.2021.662087. eCollection 2021.

    PubMed 34602963

  • Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

    PubMed 12916575

  • Laukka, P. (2006). Uses of music and psychological well-being among the elderly. Journal of Happiness Studies, 8(2), 215. https://doi.org/10.1007/s10902-006-9024-3

  • Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

    PubMed 5349366

  • Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety Stress Scales. (2nd. Ed.) Sydney: Psychology Foundation

  • Phneah SW, Nisar H. EEG-based alpha neurofeedback training for mood enhancement. Australas Phys Eng Sci Med. 2017 Jun;40(2):325-336. doi: 10.1007/s13246-017-0538-2. Epub 2017 Mar 13.

    PubMed 28290068

  • Salthouse, T. A. (1994). The Nature of the Influence Of Speed on Adult AgeDifferencesin Cognition. Developmental Psychology, 30(2), 20.

  • Sarkamo T, Tervaniemi M, Laitinen S, Numminen A, Kurki M, Johnson JK, Rantanen P. Cognitive, emotional, and social benefits of regular musical activities in early dementia: randomized controlled study. Gerontologist. 2014 Aug;54(4):634-50. doi: 10.1093/geront/gnt100. Epub 2013 Sep 5.

    PubMed 24009169

  • Schmitter-Edgecombe M, Parsey CM. Assessment of functional change and cognitive correlates in the progression from healthy cognitive aging to dementia. Neuropsychology. 2014 Nov;28(6):881-93. doi: 10.1037/neu0000109. Epub 2014 Jun 16.

    PubMed 24933485

  • Shankar A, Hamer M, McMunn A, Steptoe A. Social isolation and loneliness: relationships with cognitive function during 4 years of follow-up in the English Longitudinal Study of Ageing. Psychosom Med. 2013 Feb;75(2):161-70. doi: 10.1097/PSY.0b013e31827f09cd. Epub 2013 Jan 29.

    PubMed 23362501

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive Music Intervention and Traditional Music Intervention in people with Stress, Psychological and Executive Functions, run by Toronto Metropolitan University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life: Psychosocial functions of healthy older adults. (time frame: Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05447312, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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