AIMT: Artificial Intelligence Music Therapy for Psychosocial and Cognitive Functions of Older Adults

Sponsor
Ryerson University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05447312
Collaborator
Mitacs (Industry)
45
1
3
10
4.5

Study Details

Study Description

Brief Summary

The proposed study is a pilot study that aims to understand if the Pi Speaker dynamic artificial intelligence (AI) empathic music therapy (AIT) is effective to promote positive psychosocial and cognitive outcomes, over and above traditional music therapy (TMT), among healthy older adults. This study will contribute to the ongoing literature on the benefits of music therapy and provide insight on how AI technology can enhance the therapeutic effects of music therapy 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 (TMT), Pi Speaker's dynamic AI empathic music therapy group (AIT), 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 TMT and AIT group will receive music therapy between the pretest and posttest sessions, spanning for 4 weeks, with 4 music therapy sessions per week, and each session lasting about 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Artificial Intelligence Empathic Music Therapy
  • Behavioral: Traditional Music Therapy
N/A

Detailed Description

Objectives:
  1. to further assess the benefits of traditional music therapy (TMT) in older adults

  2. to assess the additional benefits of the Pi Speaker's dynamic AI empathic music therapy (AIT) as compared to TMT 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 AI 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 advertising. The target sample size will be 45 participants, 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 TMT and AIT 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 AIT group will be exposed to individually selected music pieces based on the data collected at pretest. The TMT group will be randomly exposed to the same set of music, but not contingent to their mood state.

Data Analysis Plan: a mixed-effects regression model will be performed on each outcome variable at posttest and follow-up sessions, with pretest performance as a covariate, and intervention conditions entered as primary predictor variables. In other words, group differences in the standardized outcome performance at the posttest and the 3-month follow-up sessions will be analyzed, controlling for the baseline pretest performance, to validate the training benefits of TMT and AIT, relative to 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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three-arm, randomized control trial for psychosocial and cognitive intervention. Participants will be in one of three groups: those receiving music enhanced by AI technology, those receiving music without enhancement, and a waitlist control receiving no intervention.Three-arm, randomized control trial for psychosocial and cognitive intervention. Participants will be in one of three groups: those receiving music enhanced by AI technology, those receiving music without enhancement, and a waitlist control receiving no intervention.
Masking:
Single (Participant)
Masking Description:
Participants in two arms (traditional music therapy and artificial intelligence music therapy 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.
Primary Purpose:
Treatment
Official Title:
The Effects of Artificial Intelligence Empathic Music Therapy on Psychosocial and Cognitive Functions of Older Adults: a Pilot and Validation Study
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Artificial Intelligence Empathic Music Therapy (AIT)

The intervention will be artificial intelligence (AI) music therapy, 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 about 30 minutes, at least 4 times in a week over 4 weeks.

Behavioral: Artificial Intelligence Empathic Music Therapy
Music therapy using music that has been enhanced by frequencies that are associated with positive feelings as measured by EEG data. Music therapy is 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:
  • Psychotherapy
  • Cognitive
  • Active Comparator: Traditional Music Therapy (TMT)

    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 about 30 minutes, at least 4 times in a week over 4 weeks.

    Behavioral: Traditional Music Therapy
    Music therapy using music that has not been enhanced by frequencies. Music therapy is delivered through the Pi Electronic Inc.'s Venus Speaker that aims to promote psychosocial and cognitive functioning.
    Other Names:
  • Psychotherapy
  • Cognitive
  • No Intervention: Waitlist (no-contact) Control

    No intervention, participants will be informed that they are on a waitlist and not be receiving music therapy for the next 4 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Depression, anxiety, stress: Psychosocial functions of healthy older adults. [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: -Depression, Anxiety, and Stress Scale - 21. Higher scores indicate higher depression, anxiety, and stress.

    2. Quality of life: Psychosocial functions of healthy older adults. [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.

    3. Resiliency: Psychosocial functions of healthy older adults. [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.

    4. Emotional Regulation: Psychosocial functions of healthy older adults. [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.

    5. Activities of Daily Living: Psychosocial functions of healthy older adults. [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.

    6. Loneliness: Psychosocial functions of healthy older adults. [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.

    7. Processing speed: Cognitive functions of healthy older adults. [Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),]

      All computerized on Eprime. Cognitive performance will be measured using the: -Letter Comparison. Increased reaction time indicates poorer processing speed.

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

      All computerized on Eprime. Cognitive performance will be measured using the: -Emotional Stroop Task. Increased reaction time to negative emotional words indicates decreased mood.

    9. Memory: Cognitive functions of healthy older adults. [Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),]

      All computerized on Eprime. Cognitive performance will be measured using the: -Hopkins Verbal Learning Test (HVLT). Higher scores indicate better verbal learning and memory (suggested cut-off of 14 for dementia).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ryerson University (renamed: Toronto Metropolitan University) Toronto Ontario Canada M5B

    Sponsors and Collaborators

    • Ryerson University
    • Mitacs

    Investigators

    • Principal Investigator: Kathryn Bolton, BA. hons, Ryerson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kathryn Bolton, Graduate Student, Ryerson University
    ClinicalTrials.gov Identifier:
    NCT05447312
    Other Study ID Numbers:
    • TMU2022-CAL-Pi-AIMT
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kathryn Bolton, Graduate Student, Ryerson University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022