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

NCT04723576 | Completed Results DMC

• 1 other identifier: COVID-2020C2-10721
• Study Type: interventional
• Target: 7,444
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Keywords

healthcare worker; stress; fatigue; anxiety; burnout; COVID-19; stress first aid

Outcome Measures

Primary Outcomes (2)

• PTSD Symptom Severity

  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.

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

• Psychological Distress

  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.

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

Secondary Outcomes (5)

• Sleep-Related Impairment

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

• Workplace Stress

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

• Resilience

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

• Burnout

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

• Moral Distress

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

Study Arms (2)

Stress First Aid

EXPERIMENTAL

The cluster Randomized Controlled Trial (cRCT) will be comprised of three cohorts of matched pairs representing approximately 40 diverse sites (12-15 pairs of hospitals hospitals and 5-7 pairs of clinics/practices) to determine whether SFA for frontline HCWs improves mental and physical well-being compared to Usual Care (UC). Each pair will be assigned to either SFA or UC using a simple 1:1 randomization. SFA sites will implement SFA through a "train-the-trainer" model.

Behavioral: Stress First Aid

Usual Care

NO INTERVENTION

The cRCT will be comprised of three cohorts of matched pairs representing approximately 40 diverse sites (12-15 pairs of hospitals hospitals and 5-7 pairs of clinics/practices) to determine whether SFA for frontline HCWs improves mental and physical well-being compared to Usual Care (UC). Each pair will be assigned to either SFA or UC using a simple 1:1 randomization. UC sites will not implement SFA during the study period but will be given full access to all implementation materials following the conclusion of their participation.

Interventions

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.

Stress First Aid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English speaking

Sponsors & Collaborators

• RAND: lead
• Stanford University: collaborator
• Clinical Directors Network: collaborator
• Vizient: collaborator

Study Sites (2)

Clinical Directors Network, Inc

New York, New York, 10018, United States

Location

Vizient Inc.

Irving, Texas, 75062, United States

Location

Related Publications (6)

• Dong L, Meredith LS, Farmer CM, Ahluwalia SC, Chen PG, Bouskill K, Han B, Qureshi N, Dalton S, Watson P, Schnurr PP, Davis K, Tobin JN, Cassells A, Gidengil CA. Protecting the mental and physical well-being of frontline health care workers during COVID-19: Study protocol of a cluster randomized controlled trial. Contemp Clin Trials. 2022 Jun;117:106768. doi: 10.1016/j.cct.2022.106768. Epub 2022 Apr 22.

  PMID: 35470104 BACKGROUND

• Meredith LS, Ahluwalia S, Chen PG, Dong L, Farmer CM, Bouskill KE, Dalton S, Qureshi N, Blagg T, Timmins G, Schulson LB, Huilgol SS, Han B, Williamson S, Watson P, Schnurr PP, Martineau M, Davis K, Cassells A, Tobin JN, Gidengil C. Testing an Intervention to Improve Health Care Worker Well-Being During the COVID-19 Pandemic: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e244192. doi: 10.1001/jamanetworkopen.2024.4192.

  PMID: 38687482 BACKGROUND

• Bandini JI, Ahluwalia SC, Timmins G, Bialas A, Meredith L, Gidengil C. "It Haunts Me": Impact of COVID-19 Deaths on Frontline Clinicians In Acute Care Settings-A Qualitative Study. Am J Crit Care. 2023 Sep 1;32(5):368-374. doi: 10.4037/ajcc2023257.

  PMID: 37652873 BACKGROUND

• Timmins GT, Bandini JI, Ahluwalia SC, Bialas A, Meredith LS, Gidengil C. 'You just don't feel like your work goes recognised': healthcare worker experiences of tension related to public discourse around the COVID-19 pandemic. BMJ Lead. 2024 Dec 23;8(4):324-328. doi: 10.1136/leader-2024-000983.

  PMID: 38553036 BACKGROUND

• Qureshi N, Huilgol SS, Timmins G, Meredith LS, Gidengil CA. Misaligned Supports: Differences in Reported Health Care Worker Well-being Supports Provided and Needed During the COVID-19 Pandemic. Am J Health Promot. 2025 Jan;39(1):63-75. doi: 10.1177/08901171241255764. Epub 2024 Jun 21.

  PMID: 38907369 BACKGROUND

• Timmins G, Williamson S, Cassells A, Davis K, Dong L, Tobin JN, Gidengil C, Meredith LS, Chen PG. Health care worker experiences with a brief peer support and well-being intervention during the COVID-19 pandemic. BMC Health Serv Res. 2025 Sep 30;25(1):1253. doi: 10.1186/s12913-025-13268-6.

  PMID: 41029307 DERIVED

MeSH Terms

Conditions

Fatigue; Anxiety Disorders; Burnout, Psychological; COVID-19

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Response rate was low (only 28% completed both the pre-intervention and post-intervention surveys).

Results Point of Contact

• Title: Lisa S. Meredith
• Organization: RAND

seidel@rand.org

310.393.0411

Study Officials

• Melanie Renzi

  RAND

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking of research staff will be performed to the extent possible in this study. The survey data can be analyzed in a blinded fashion. However, due to the nature of qualitative research (described below), masking will not be possible for this data collection effort. Given that no qualitative research can be performed in a blinded way, we do not anticipate the lack of masking to affect our qualitative results adversely.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Behavioral Scientist

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 25, 2021
• Study Start: March 11, 2021
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: December 2022
• Access Criteria: The study data are available to qualified researchers and provided a de-identified copy of the study data and related documentation to the REGENTS OF THE UNIVERSITY OF MICHIGAN on behalf of the INTER-UNIVERSITY CONSORTIUM FOR POLITICAL AND SOCIAL RESEARCH (ICPSR) for the purpose of allowing ICPSR to examine, process, and distribute the data to qualified researchers as determined by ICPSR.

Locations

US (2)