Clinical trial NCT04551274: Music Therapy in Frontline Healthcare Workers
Official title: Investigating the Use of Virtual Music Therapy in Frontline Healthcare Workers During COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood
Emotional Stress
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: Music Heals Charitable Foundation
First posted: 2020-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Perceived Stress score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in General Life Satisfaction score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in Positive Affect score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in Anger score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in Fear score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in Meaning & Purpose score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in Sadness score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in Emotional Support score - NIH Emotion Toolbox
timeFrame: 4 weeks
measure: Change in Loneliness score - NIH Emotion Toolbox
timeFrame: 4 weeks
Secondary outcomes:
measure: EEG - Change in power in the Delta band
timeFrame: 4 weeks
measure: EEG - Change in power in the Beta band
timeFrame: 4 weeks
measure: EEG - Change in power in the Alpha band
timeFrame: 4 weeks
measure: EEG - Change in power in the Theta band
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Simon Fraser University
state: British Columbia
Study officials:
affiliation: Simon Fraser University
name: Glen Chapman, PhD
role: STUDY_DIRECTOR
References: