COVID-19 and Mental Health

September 2, 2021 updated by: Kara Pavone, Northeastern University

Mental Health Outcomes Among US Healthcare Workers Exposed to COVID-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthcare providers (nurses and physicians) on the frontlines of the COVID-19 response are facing a critical situation and are subject to increased psychological distress. Those directly involved in the diagnosis, treatment and care of patients with COVID-19 are at significant risk of developing physical, psychological, and psychosocial distress.

The data examined in this study will further clarify the mental distress experienced by healthcare workers and lead to the development of peer-support and educational initiatives to improve these findings. The central hypothesis of this research is that high levels of mental distress will be associated with caring for patients with COVID-19.

This study will use an observational, cross-sectional on-line survey design. Participants will complete a 15 minute self-administered questionnaire. All data will be de-identified.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Northeastern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
This is an observational design. Participants are exposed to the Covid-19 pandemic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Impact
Time Frame: 7 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 2 weeks
Patient Health Questionaire (PHQ-9). The PHQ-9 has a range from 0 - 27. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
2 weeks
Anxiety
Time Frame: 2 weeks
Generalized Anxiety Disorder 7-item (GAD-7). Scores range from 0 - 21. When screening for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
2 weeks
Insomnia
Time Frame: 1 week
The ISI7 is a 7-item instrument designed to assess the nature, severity, and impact of insomnia in adults. Scores range from 0 - 28. Higher scores indicate increased likelihood of sleep disturbances.
1 week
Resilience
Time Frame: 2 Weeks
Brief Resilience Scale (BRS) is a 6-item scale with scores ranging from 6-30 with higher scores indicating greater resilience.
2 Weeks
Crisis Support Scale
Time Frame: 2 weeks
The Crisis Support Scale (CSS) is a 7-item instrument developed to measure received social support. Scores range from 7 - 98, with higher scores correlating with increased social support.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northeastern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-05-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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