COVID-19 and Mental Health

Completed

• Conditions: Mental Health Disorder; COVID-19
• Interventions: Other: Exposure to the SARS-CoV-2

• Registration Number: NCT04407195
• Lead Sponsor: Northeastern University

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.

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 Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Study Start: 2020-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthcare Providers	Exposure to the SARS-CoV-2	Healthcare workers (physicians and nurses) who have interacted with patients with known or suspected COVID-19.

Primary Outcome Measures

Name	Time	Method
Emotional Impact	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

Name	Time	Method
Insomnia	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.
Resilience	2 Weeks	Brief Resilience Scale (BRS) is a 6-item scale with scores ranging from 6-30 with higher scores indicating greater resilience.
Depression	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.
Anxiety	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.
Crisis Support Scale	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.

Trial Locations

Locations (1)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States