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Stress First Aid for COVID-19 Frontline Health Care Workers (COVER-HCW Trial)

N/A

Waitlist Available

Research Sponsored by RAND

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-sfa intervention: months 1 to 2

Awards & highlights

COVER-HCW Trial Summary

This trial will help support the mental and physical well-being of US health care workers during the COVID-19 pandemic.

Eligible Conditions

Healthy Subjects

COVER-HCW Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-sfa intervention: months 1 to 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-sfa intervention: months 1 to 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-sfa intervention: months 1 to 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PTSD

Posttraumatic Stress Disorder (PTSD)

Psychological Distress

Secondary outcome measures

Burnout

Moral Distress

Resilience

+2 more

COVER-HCW Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stress First AidExperimental Treatment1 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. SFA sites will implement SFA through a "train-the-trainer" model.

Group II: Usual CareActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stress First Aid

2016

N/A

~660

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Who is running the clinical trial?

RANDLead Sponsor

137 Previous Clinical Trials

508,119 Total Patients Enrolled

Stanford UniversityOTHER

2,386 Previous Clinical Trials

17,331,876 Total Patients Enrolled

Clinical Directors NetworkNETWORK

12 Previous Clinical Trials

12,114 Total Patients Enrolled

Media Library

Stress First Aid Clinical Trial Eligibility Overview. Trial Name: NCT04723576 — N/A

Healthy Subjects Research Study Groups: Stress First Aid, Usual Care

Healthy Subjects Clinical Trial 2023: Stress First Aid Highlights & Side Effects. Trial Name: NCT04723576 — N/A

Stress First Aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04723576 — N/A

Healthy Subjects Patient Testimony for trial: Trial Name: NCT04723576 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the principal goal of this medical study?

"This clinical trial, which is set to take place over two months, aims to reduce the prevalence of Post-Traumatic Stress Disorder (PTSD). Additional goals include improving resilience as measured by Connor Davidson Resilience Scale (CDRISC), reducing workplace stress according to American Psychological Association's Stress in the Workplace survey and assessing burnout with Dolan single item burnout inventory."

Answered by AI

Are there any vacancies for participants in this experiment?

"According to clinicaltrials.gov, this research effort is still taking applications from volunteers who wish to participate in the trial. The study was first launched on March 11th 2021 and its information has been recently refreshed on October 24 2022."

Answered by AI

How many participants can potentially be enrolled in this research?

"Affirmative. Online records on clinicaltrials.gov make clear that this scientific experiment has commenced patient recruitment, which began on March 11th 2021 and is still ongoing after the most recent edit made on October 24th 2022. In total, 2132 individuals are required to take part in this single-site trial."

Answered by AI