COVID-19 and Mental Health

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407195
• Other study ID #: 20-05-22
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2021
• Source: Northeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Mental Disorders
• Mental Health Disorder

Intervention

Other:
• Exposure to the SARS-CoV-2
This is an observational design. Participants are exposed to the Covid-19 pandemic.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Depression	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
Secondary	Anxiety	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
Secondary	Insomnia	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
Secondary	Resilience	Brief Resilience Scale (BRS) is a 6-item scale with scores ranging from 6-30 with higher scores indicating greater resilience.	2 Weeks
Secondary	Crisis Support Scale	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