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Completed

NCT Number: NCT04723576

Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)

Study to support the mental and physical well-being of US health care workers during the COVID-19 pandemic and ensure high-quality care for patients through Stress First Aid.

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Key information

Conditions

Healthy Anxiety Disorders Behavior Behavioral Symptoms Burnout, Psychological COVID-19 Coronaviridae Infections Coronavirus Infections Fatigue Infections Lung Diseases Mental Disorders Nidovirales Infections Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stress, Psychological Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Directors Network, Inc, New York, United States

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About this study

The goal of the project is to support the mental and physical well-being of U.S. health care workers (HCWs) during the COVID-19 pandemic to ensure high-quality care for patients, by establishing the effectiveness of a tailored Stress First Aid (SFA) intervention, compared to usual care (UC). The RAND Corporation will conduct a cluster randomized controlled trial (cRCT) with three cohorts containing matched pairs in approximately 40 diverse sites (hospitals and clinics) to evaluate whether SFA for HCWs improves mental and physical well-being compared to UC. Sequential roll-out of the intervention to three cohorts will allow investigators to quickly incorporate lessons learned and stakeholder feedback from each iteration into subsequent trainings, and share actionable findings given the urgency due to the pandemic. The end result will be an SFA toolkit tailored for HCWs that can be implemented and scaleable across multiple settings. The proposed SFA intervention addresses an important and compelling clinical care delivery challenge during COVID-19 by improving the mental well-being of HCWs, who will benefit directly and be better equipped to provide higher quality, more sustained, and more patient-centered care to patients. The specific aims of the project are to: (1) test the comparative effectiveness of SFA versus UC on mental and physical well-being (quantitative); (2) understand and document any UC activities to support HCW well-being prior to implementing SFA across sites; and (3) assess the experiences of HCWs and sites with SFA (acceptability, likelihood of uptake, lessons learned) and impact on HCW well-being (qualitative).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Health care workers and patient-facing support staff (e.g., front desk staff)

Exclusion criteria

  • Non-English speaking

Treatment and study plan

Stress First Aid

Behavioral

Stress First Aid (SFA) is an evidence-based intervention to mitigate the psychosocial impact of COVID-19 on Health Care Workers (HCWs). SFA was initially developed for the United States Navy and Marine Corps as a framework of actions for peer support delivered by individuals without mental health training. SFA is designed to teach simple, supportive actions that can be seamlessly integrated into work environments. SFA training focuses on five essential principles: cover (restore and support a sense of safety), calm (encourage simple strategies such as breathing), connect (engage in and promote social support), competence (improve ability to address crucial needs and concerns), and confidence (increase hope and limit self-doubt and guilt). In this study, we are adapting the SFA model to include HCW-specific examples of SFA actions and case scenarios specific to the COVID-19 pandemic and will implement SFA using a "train-the trainer" model.

Primary outcomes

  1. PTSD Symptom Severity

    Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

    Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual (DSM) of Mental Disorders (PCL-5). The PCL-5 is a 20-item measure of PTSD symptom severity. Each item is rated on 0-4 frequency scale. Items are summed to create a total score ranging from 0-80 where a higher score indicates worse outcomes.

  2. Psychological Distress

    Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

    Kessler 6 Distress Scale (K-6) for general psychological distress in the past 30 days. This is a 6-item inventory. Each of the items is scored from "none of the time" (0) to "all of the time" (4). Items are summed for a total score ranging from 0-24 where a higher score indicates worse outcomes.

Secondary outcomes

  1. Sleep-Related Impairment

    Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment (SRI) includes 4 items to assess sleep impairment over the past seven days. Each of the items are rated from 1-5 (not at all to very much). Items are summed into a scale ranging from 4-20 where a higher score indicates worse outcomes.

  2. Workplace Stress

    Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

    American Psychological Association's (APA) Stress in the Workplace survey; 3 items rated on a 1-5 scale from strongly disagree to strongly agree. A summed scale is formed ranging from 3-15 in which a higher score indicates worse outcomes/more stress.

  3. Resilience

    Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

    Connor Davidson Resilience Scale (CDRISC); a brief (2-item) version of the scale with items rated from 0-4 (not true at all to true nearly all the time). Items are summed into a total scale ranging from 0-8 in which a higher score indicates better outcomes.

  4. Burnout

    Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

    Dolan single item with 5 responses options ranging from 1[I enjoy my work. I haven symptoms of burnout.] to 5 [I feel completely burned out.]; We created a binary indicator to measure the percent of participants who reported experiencing symptoms of burnout.

  5. Moral Distress

    Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)

    We used the Moral Distress Thermometer, a single item sliding scale with responses rated on a 0-10 scale (none to worst possible) where a higher score indicates worse outcomes.

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Clinical Directors Network
  • Stanford University
  • Vizient

Registry information

Acronym: COVER-HCW

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 25, 2021
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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