Music Therapy in Frontline Healthcare Workers

September 10, 2020 updated by: Ryan D'Arcy, Simon Fraser University

Investigating the Use of Virtual Music Therapy in Frontline Healthcare Workers During COVID-19

The objective of this project is to investigate the impacts of the COVID-19 pandemic on frontline healthcare workers, and determine if a virtual music therapy can improve mood and emotional state in this population.

For this pilot study, EEG will also be used to assess measures of functional connectivity, attention, and mood in adult participants. Participants will also be evaluated for measures of emotion using a standardized test battery (NIH toolbox).

This pilot study will show how frontline healthcare workers have been impacted by the COVID-19 pandemic, and provide evidence as to the effectiveness of Music Therapy to support mental health in this essential population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose:

The purpose of this study is to investigate (a) the self-described impact that the COVID-19 pandemic has had on frontline healthcare workers, and (b) the use of music therapy to improve mental healththis population. Built on top of our successful neuroscience and neuroimaging research, we aim to use behavioural assessments combined with portable EEG technology to monitor how metrics of brain function and mental health change over time in frontline healthcare workers undergoing Music Therapy.

Hypothesis:

We expect to see improvements in behavioural/emotional metrics as a result of music therapy - with correlations to changes in brain activation, markers of attention, and connectivity.

Justification:

Music Therapy interventions involve the use of live music (performed or created by the therapist and/or patient), and a process that includes patient-specific assessment, treatment, and evaluation. Music Therapy has shown to be effective in addressing symptoms related to global and social functioning in schizophrenia and/or serious mental disorders, gait and related activities in Parkinson's disease, depressive symptoms, and sleep quality.

Objectives:

  1. The first objective of this study is to investigate how the COVID-19 pandemic has affected the lives of frontline healthcare workers
  2. The second objective is to investigate the effect of music therapy on mental health in frontline healthcare workers during the COVID-19 pandemic
  3. The third objective is to investigate EEG-related changes in frontline healthcare workers with music therapy, and correlate to behavioural changes

Research Design:

This is a longitudinal study design. 20 frontline healthcare workers will be recruited. 10 will be randomly assigned to no therapy (control) and 10 will be assigned to a music therapy (intervention) group. Random assignment will be prospectively performed using Microsoft Excel. Each subject code will be randomly assigned a decimal number from 0-1. All subject codes will then be sorted with their random numbers in ascending order. The 10 subject codes with the largest number will be placed in the intervention group, and the remaining 10 in the control group

Participants in the therapy group will complete 4 weeks of music therapy. Experimental measures will be completed before and after the 4 week period.

Statistical Analysis:

Outcomes from the EEG and behavioural assessments will be compared across groups and time points using a repeated Measures Analysis of Variance (ANOVA).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ryan CN D'Arcy, PhD
  • Phone Number: +1 7789199215
  • Email: rdarcy@sfu.ca

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5A 1S6V
        • Simon Fraser 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All participants will be required to be frontline healthcare workers, (i.e. paramedics, EMTs, nurses, doctors). Participants will be adults aged 19 years and above, who are English speakers, with normal or corrected vision and hearing abilities. Participants will be required to have independent capacity to consent, as per Article 3.3 of the TCPS2. Due to the virtual nature of the study, participants will need to have access to a computer/laptop with a webcam to be able to interact with the music therapist and the study team.

Exclusion Criteria:

  • Participants who have experienced a traumatic brain injury in the last 12 months, or who have previously been diagnosed with any other neurological, neuropsychological, or psychiatric diseases/disorders/conditions will not be enrolled in the study.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Music Therapy
Participants in the music therapy group will complete a 4 week music therapy program, with a minimum of 2 sessions per week.
Behavioral: Music Therapy
Music Therapy interventions involve the use of live music (performed or created by the therapist and/or patient), and a process that includes patient-specific assessment, treatment, and evaluation
NO_INTERVENTION: Control
Control group participants will not experience any intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in General Life Satisfaction score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in Positive Affect score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in Anger score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in Fear score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in Meaning & Purpose score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in Sadness score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in Emotional Support score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks
Change in Loneliness score - NIH Emotion Toolbox
Time Frame: 4 weeks
The NIH Toolbox Emotion Battery is a comprehensive set of neuro-behavioral measurements that quickly assess emotional functions. It consists of surveys in the domains of Negative Effect ,Psychological Well-Being, Stress & Self-Efficacy, and Social Relationships. It is based on a nationally representative sample to enable cross-measure comparisons, and is well-suited for measuring outcomes in longitudinal studies. Questions for each subitem are arranged on a likert scale with associated scores from 1-5. The overall score for each measure (at each time point) is calculated as the sum of scores for each question.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EEG - Change in power in the Delta band
Time Frame: 4 weeks
Resting-state EEG will be recorded
4 weeks
EEG - Change in power in the Beta band
Time Frame: 4 weeks
Resting-state EEG will be recorded
4 weeks
EEG - Change in power in the Alpha band
Time Frame: 4 weeks
Resting-state EEG will be recorded
4 weeks
EEG - Change in power in the Theta band
Time Frame: 4 weeks
Resting-state EEG will be recorded
4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Simon Fraser University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Music Heals Charitable Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Glen Chapman, PhD, Simon Fraser University

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 (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H20-02015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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