Music Therapy in Frontline Healthcare Workers

NCT ID: NCT04551274

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2020-11-30

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).

Conditions

Mood; Emotional Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Music Therapy

Participants in the music therapy group will complete a 4 week music therapy program, with a minimum of 2 sessions per week.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: BEHAVIORAL

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

Control

Control group participants will not experience any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Music Heals Charitable Foundation

UNKNOWN

Sponsor Role: collaborator

Simon Fraser University

OTHER

Sponsor Role: lead

Responsible Party

Ryan D'Arcy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glen Chapman, PhD

Role: STUDY_DIRECTOR

Simon Fraser University

Locations

Simon Fraser University

Burnaby, British Columbia, Canada

Countries

Canada

Central Contacts

Ryan CN D'Arcy, PhD

Role: CONTACT

rdarcy@sfu.ca

7789199215 ext. +1

Facility Contacts

Shaun D Fickling, PhD

Role: primary

sficklin@sfu.ca

Other Identifiers

H20-02015

Identifier Type: -

Identifier Source: org_study_id