- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497415
The COVID-19 and Healthcare Workers: An Active Intervention
The overarching goal of this study is to examine the efficacy of a brief video intervention in reducing stigma and fear, and improving help-seeking behavior, among health care providers (N=1,200), with pre- post- and follow-up assessments (at day 14 and day 30). Participants will be recruited via Amazon Turk and randomly assigned to either a) a video-based intervention (day 1 and a "booster intervention" of the same content on day 14 of the study) featuring the personal story of a health care provider during COVID-19 pandemic, his/her struggles and barriers to care, (b) video-based intervention (day 1 only), and a written description of the same story on day 14 (c) no-intervention control arm (questionnaires only).
The invetsigators aim to (1) determine whether video-based intervention reduce stigma and fear, and increase help-seeking behavior in relation to COVID-19 among health care providers, and (2) compare high-risk areas (e.g., NY) to low-risk areas (e.g., Montana) on intervention outcomes, and (3) test whether symptoms of depression, anxiety, PTSD and Moral Injury (measured by the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and the Moral Injury Events Scale (MIES)) would change over time.
Study Overview
Status
Intervention / Treatment
Detailed Description
Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world. To effectively respond to the COVID-19 outbreak, various governments have implemented rapid and comprehensive public health emergency interventions that include social restrictions and quarantines, which is the separation and restriction of movement of people who might have been exposed to the virus. While the physical risk (e.g. pneumonia, respiratory breakdown) is getting the most scientific and clinical attention, this outbreak also has significant mental health risks and extreme psychological fear-related responses. Psychological responses to previous large-scale outbreaks, particularly to the Ebola Virus Disease (EVD) epidemic during 2014-2016, provide insight into the potential impact of rapidly spreading diseases on mental health problems. During the Ebola outbreak, fear-related behaviors such as stigmatizing infected survivors and ignoring medical procedures impeded public health efforts and negatively affected the recovery of survivors. Anxiety, posttraumatic stress disorder (PTSD), and depression were found in nearly half of the EVD survivors and their contacts.
The COVID-19 outbreak exceeds the scope and magnitude of most previous disasters over the last 100 years. It entails a blend of risk factors for both acute and long-term mental health problems. Data that is started to emerge from the COVID-19 outbreak, suggest that front lines health workers (doctors; nurses) are particularly at risk. A recent study in 1257 health care workers from 34 hospitals, conducted between January 29 to February 3, 2020, revealed that more than half (50.4%) of the health workers were screened positive for depression, 44.6% for anxiety, and 34.0% for insomnia. Consistent with previous disaster studies a dose-response relationship was found between the level of exposure and outcomes. Others may develop a moral injury, profound psychological distress which results in actions, or the lack of them, which violet one's moral or ethical code. Given the magnitude of the COVID-19 outbreak, its risk to physical and mental health, an effective and timely response is essential to address the psychosocial needs associated with the ongoing exposure to disease, death, and distress among health care providers, across low and high risks areas.
Many health care providers reluctant to seek support from friends and family, as well as mental health care due to stigma and fear (e.g., "it would be too embarrassing", "I would be seen as week"). Despite enduring symptoms, they may wait months to years before they seek help. Among reasons to avoid seeking mental health care, individuals report mistrust in mental health providers, being seen as weak or stereotyped as "crazy", and a belief that they may be responsible for having mental health problems. Applying strategies to reduce stigma and fear towards mental health care and improve help-seeking behavior may ameliorate impaired functioning and reduce risks for long-term psychiatric illness.
Previous studies have shown that social contact is the most effective type of intervention to reduce stigma- related attitudes and to improve help-seeking behavior. Social contact involves interpersonal contact with members of the stigmatized group: members of the general public who meet and interact with individuals who suffer from stress, fear, depression, or anxiety and seek mental health care, are likely to lessen their stigma. Corrigan has identified the most important ingredients of contact-based programs: an empowered presenter with lived experience who attains his/her goals (e.g., "I was able to fight the depression/distress that I had following the COVID-19"). While both direct, in-person social contact and indirect, video-based social contact have effectively improved attitudes toward mental issues and care, the latter can be implemented on a larger scale, use a minimal resource and easily disseminated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
English speakers Healthcare workers aged 18-80 and residents of the USA.
Exclusion Criteria:
Non-English speakers, non-healthcare workers, age less than 18 or more than 80, non-US residents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video-based intervention
A brief video about coping with COVID-19 stress presented to the participants
|
Three minutes video of a nurse that shares her personal story
|
|
No Intervention: Assessment only
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Help-seeking Behavior
Time Frame: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)
|
Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions
|
Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)
|
|
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety
|
Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression
|
Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
|
Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen
Time Frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms
|
Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
|
Moral Injury Events Scale (MIES)
Time Frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury
|
Assessed at baseline, 14-day follow-up, and 30-day follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuval Neria, PhD, Columbia University and NYSPI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 8032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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