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
|Condition or disease||Intervention/treatment|
|COVID-19 Mental Health Disorder||Other: Exposure to the SARS-CoV-2|
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|
|Estimated Enrollment :||2000 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|