HealthyCOVER-HCWNCT04723576
Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
A study testing Stress First Aid in people with Healthy, run by RAND at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Stress First Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,444 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2021to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health care workers and patient-facing support staff (e.g., front desk staff)
Who cannot join
- Non-English speaking
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vizient Inc.
Irving, Texas, 75062
Clinical Directors Network, Inc
New York, New York, 10018
About this study
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.
Read the detailed description
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).
- Conditions
- Healthy
- Being tested
- Stress First Aid
- Keywords
- healthcare worker, stress, fatigue, anxiety, burnout, COVID-19, stress first aid
- Medical subject headings
- Fatigue, Anxiety Disorders, Burnout, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress First AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Secondary outcomes (5)
Sleep-Related Impairment
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.
Measured: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Workplace Stress
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.
Measured: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Resilience
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.
Measured: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Burnout
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.
Measured: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Moral Distress
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.
Measured: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start11 Mar 2021
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Clinical Directors Network, Vizient
- Responsible party
- Principal investigator, Lisa Meredith, RAND
- Investigators
- Melanie Renzi, Study director, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723576
- Sponsor's protocol ID
- COVID-2020C2-10721
- Other IDs
- COVID-2020C2-10721
- Acronym
- COVER-HCW
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2021
- Last updated
- 8 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow the funder's protocol for uploading data.
Publications
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.
PubMed 35470104Meredith 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.
PubMed 38687482Bandini 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.
PubMed 37652873Timmins 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.
PubMed 38553036Qureshi 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.
PubMed 38907369Timmins 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.
PubMed 41029307
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental and Physical Well-Being of Frontline Health Care Workers During Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04723576
- Acronym / sponsor ID
- COVER-HCW / COVID-2020C2-10721
- Conditions
- Healthy
- Keywords
- healthcare worker, stress, fatigue, anxiety, burnout, COVID-19, stress first aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,444 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Stanford University, Clinical Directors Network, Vizient
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 8 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress First Aid | Experimental | Behavioral: Stress First AidThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Health care workers and patient-facing support staff (e.g., front desk staff)
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress First AidStress 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. | Behavioural | Stress First Aid |
Primary outcome
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.
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.
5 secondary outcomes
Sleep-Related Impairment
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Workplace Stress
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Resilience
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Burnout
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Moral Distress
Time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35470104Dong 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.
- Background: PubMed 38687482Meredith 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.
- Background: PubMed 37652873Bandini 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.
- Background: PubMed 38553036Timmins 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.
- Background: PubMed 38907369Qureshi 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.
- Derived from this study: PubMed 41029307Timmins 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.
- Individual participant dataSharing planned: Yes. We will follow the funder's protocol for uploading data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Renzi study director
RAND
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress First Aid in people with Healthy, run by RAND at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Severity (time frame: Pre-Intervention (Baseline) and Post-Intervention (29 to 53 days from Baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723576, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.