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COVID-19 and Mental Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407195
Recruitment Status : Active, not recruiting
First Posted : May 29, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Kara Pavone, Northeastern University

Study Description
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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.

Condition or disease Intervention/treatment
COVID-19 Mental Health Disorder Other: Exposure to the SARS-CoV-2

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 Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mental Health Outcomes Among US Healthcare Workers Exposed to COVID-19
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will include physicians and nurse who interact with patients with known or suspected COVID-19.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407195


Locations
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United States, Massachusetts
Northeastern University
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Northeastern University
More Information
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Responsible Party: Kara Pavone, Assistant Professor, Northeastern University
ClinicalTrials.gov Identifier: NCT04407195    
Other Study ID Numbers: 20-05-22
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders