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

Primary Purpose

Stress, Psychological, Executive Functions, Loneliness

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adaptive Music Intervention
Traditional Music Intervention
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Older adults, Music therapy, Cognition, Psychosocial, Intervention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ryerson University (renamed: Toronto Metropolitan University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Adaptive Music Intervention (AM)

Traditional Music Intervention (TM)

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2022
Last Updated
October 17, 2023
Sponsor
Toronto Metropolitan University
Collaborators
Mitacs
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1. Study Identification

Unique Protocol Identification Number
NCT05447312
Brief Title
Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults
Acronym
AMT
Official Title
The Effects of an Adaptive Music Program on Psychosocial and Cognitive Functions of Older Adults: a Pilot and Validation Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
Mitacs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Objectives: to further assess the benefits of traditional music interventions (TM) in older adults to assess the additional benefits of the Pi Electronics adaptive music intervention (AM) as compared to TM in older adults to assess the long-term durability over a 3-month period of the training benefits, if any 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Executive Functions, Loneliness, Emotion Regulation, Functional Abilities, Well Being
Keywords
Older adults, Music therapy, Cognition, Psychosocial, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Music Intervention (AM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Music Intervention (TM)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Adaptive Music Intervention
Other Intervention Name(s)
Cognitive
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Music Intervention
Other Intervention Name(s)
Cognitive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life: Psychosocial functions of healthy older adults.
Description
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.
Time Frame
Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),
Title
Resiliency: Psychosocial functions of healthy older adults.
Description
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.
Time Frame
Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),
Title
Emotional Regulation: Psychosocial functions of healthy older adults.
Description
All computerized on Qualtrics, no cut off scores. Psychosocial functioning will be assessed using the: -Emotion Regulation Questionnaire. Higher scores indicate increased emotional regulation.
Time Frame
Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),
Title
Activities of Daily Living: Psychosocial functions of healthy older adults.
Description
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.
Time Frame
Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),
Title
Loneliness: Psychosocial functions of healthy older adults.
Description
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.
Time Frame
Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),
Title
Emotional processing: Cognitive functions of healthy older adults.
Description
All computerized on PsychoPy. Cognitive performance will be measured using the: -Emotional Stroop Task. Increased reaction time to negative emotional words indicates decreased mood.
Time Frame
Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),
Title
Processing Speed: Cognitive functions of healthy older adults.
Description
All computerized on PsychoPy. Cognitive performance will be measured using the: -Digit Symbol Substitution Test. Increased accuracy indicates better processing speed efficiency.
Time Frame
Baseline (pretest), 4 weeks (posttest), and 16 weeks (3-month follow-up),

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Bolton, BA. hons
Phone
4038504258
Email
kathryn.bolton@torontomu.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lixia Yang, PhD
Phone
4169795000
Ext
6522
Email
lixiay@torontomu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Bolton, BA. hons
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ryerson University (renamed: Toronto Metropolitan University)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Bolton, MA
Phone
4038504258
Email
kathryn.bolton@torontomu.ca
First Name & Middle Initial & Last Name & Degree
Lixia Yang, PhD
Phone
4169795000
Ext
6522
Email
lixiay@torontomu.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Adaptive Music Therapy for Psychosocial and Cognitive Functions of Older Adults

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