MoodNCT04551274
Music Therapy in Frontline Healthcare Workers
A study testing Music Therapy in people with Mood and Emotional Stress, run by Simon Fraser University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood, Emotional Stress
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Simon Fraser University
Burnaby, British Columbia, V5A 1S6V
Shaun D Fickling, PhD, sficklin@sfu.ca
Ryan CN D'Arvy, PhD
About this study
Official title: 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.
Read the 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:
- The first objective of this study is to investigate how the COVID-19 pandemic has affected the lives of frontline healthcare workers
- The second objective is to investigate the effect of music therapy on mental health in frontline healthcare workers during the COVID-19 pandemic
- 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
- Being tested
- Music Therapy
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Participants in the music therapy group will complete a 4 week music therapy program, with a minimum of 2 sessions per week. Receives: Behavioral: Music Therapy |
| Control | No intervention | Control group participants will not experience any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Secondary outcomes (4)
EEG - Change in power in the Delta band
Resting-state EEG will be recorded
Measured: 4 weeks
EEG - Change in power in the Beta band
Resting-state EEG will be recorded
Measured: 4 weeks
EEG - Change in power in the Alpha band
Resting-state EEG will be recorded
Measured: 4 weeks
EEG - Change in power in the Theta band
Resting-state EEG will be recorded
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- Music Heals Charitable Foundation
- Responsible party
- Principal investigator, Ryan D'Arcy, Simon Fraser University
- Investigators
- Glen Chapman, PhD, Study director, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551274
- Sponsor's protocol ID
- H20-02015
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of Virtual Music Therapy in Frontline Healthcare Workers During COVID-19
- ClinicalTrials.gov ID
- NCT04551274
- Acronym / sponsor ID
- H20-02015
- Conditions
- Mood, Emotional Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- Music Heals Charitable Foundation
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The first objective of this study is to investigate how the COVID-19 pandemic has affected the lives of frontline healthcare workers
- The second objective is to investigate the effect of music therapy on mental health in frontline healthcare workers during the COVID-19 pandemic
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music TherapyParticipants in the music therapy group will complete a 4 week music therapy program, with a minimum of 2 sessions per week. |
| Control | No intervention | –Control group participants will not experience any intervention |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyMusic 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 | Behavioural | Music Therapy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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 secondary outcomes
EEG - Change in power in the Delta band
Time frame: 4 weeks
EEG - Change in power in the Beta band
Time frame: 4 weeks
EEG - Change in power in the Alpha band
Time frame: 4 weeks
EEG - Change in power in the Theta band
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Chapman, PhD study director
Simon Fraser University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Mood and Emotional Stress, run by Simon Fraser University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan CN D'Arcy, PhD (7789199215 ext. +1, rdarcy@sfu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress score - NIH Emotion Toolbox (time frame: 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.