Music Therapy in Frontline Healthcare Workers

Mood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04551274
• Other study ID #: H20-02015
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2020
• Source: Simon Fraser University
• Contact: Ryan CN D'Arcy, PhD
• Phone: 7789199215
• Email: rdarcy[@]sfu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Stress
• Mood
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
Canada	Simon Fraser University	Burnaby	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Simon Fraser University	Music Heals Charitable Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Perceived Stress score - NIH Emotion Toolbox	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
Primary	Change in General Life Satisfaction score - NIH Emotion Toolbox	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
Primary	Change in Positive Affect score - NIH Emotion Toolbox	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
Primary	Change in Anger score - NIH Emotion Toolbox	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
Primary	Change in Fear score - NIH Emotion Toolbox	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
Primary	Change in Meaning & Purpose score - NIH Emotion Toolbox	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
Primary	Change in Sadness score - NIH Emotion Toolbox	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
Primary	Change in Emotional Support score - NIH Emotion Toolbox	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
Primary	Change in Loneliness score - NIH Emotion Toolbox	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	EEG - Change in power in the Delta band	Resting-state EEG will be recorded	4 weeks
Secondary	EEG - Change in power in the Beta band	Resting-state EEG will be recorded	4 weeks
Secondary	EEG - Change in power in the Alpha band	Resting-state EEG will be recorded	4 weeks
Secondary	EEG - Change in power in the Theta band	Resting-state EEG will be recorded	4 weeks