The COVID-19 and Healthcare Workers: An Active Intervention

NCT ID: NCT04497415

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2021-01-30

Brief Summary

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.

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.

Conditions

Brief Video-based Intervention; Non Intervention Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Video-based intervention

A brief video about coping with COVID-19 stress presented to the participants

Group Type: EXPERIMENTAL

Video-Based intervention

Intervention Type: OTHER

Three minutes video of a nurse that shares her personal story

Assessment only

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Video-Based intervention

Three minutes video of a nurse that shares her personal story

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Yuval Y Neria

Professor of medical psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuval Neria, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University and NYSPI

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

8032

Identifier Type: -

Identifier Source: org_study_id