NCT04407195

Brief Summary

The overall objective of this study is to assess the enormity of mental health outcomes among healthcare providers (nurses and physicians) exposed to COVID-19 during the time of the pandemic in the United States, specifically targeting those areas most effected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

May 27, 2020

Last Update Submit

September 2, 2021

Conditions

COVID-19Mental Health Disorder

Outcome Measures

Primary Outcomes (1)

  • Emotional Impact

    The Impact of Event Scale - Revised (IES-R). IES-R is a 22-item scale with possible scores ranging from 0 - 88. Scores higher than 24 are of concern indicating possible health and well-being consequences.

    7 days

Secondary Outcomes (5)

  • Depression

    2 weeks

  • Anxiety

    2 weeks

  • Insomnia

    1 week

  • Resilience

    2 Weeks

  • Crisis Support Scale

    2 weeks

Study Arms (1)

Healthcare Providers

Healthcare workers (physicians and nurses) who have interacted with patients with known or suspected COVID-19.

Other: Exposure to the SARS-CoV-2

Interventions

Exposure to the SARS-CoV-2OTHER

This is an observational design. Participants are exposed to the Covid-19 pandemic.

Healthcare Providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include physicians and nurse who interact with patients with known or suspected COVID-19.

You may qualify if:

  • Healthcare providers (physicians and nurse) working in institutions with known or suspected COVID-19.

You may not qualify if:

  • Nurses and physicians who are retired, or not currently employed or not working in an environment with known or suspected COVID-19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

COVID-19Mental Disorders

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 29, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)