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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
No Placebo-Only Group
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
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PTSD
Posttraumatic Stress Disorder (PTSD)
Psychological Distress
Secondary study objectives
Burnout
Moral Distress
Resilience
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
RANDLead Sponsor
141 Previous Clinical Trials
613,979 Total Patients Enrolled
Stanford UniversityOTHER
2,484 Previous Clinical Trials
17,513,962 Total Patients Enrolled
Clinical Directors NetworkNETWORK
12 Previous Clinical Trials
12,114 Total Patients Enrolled
VizientUNKNOWN
Melanie RenziStudy DirectorRAND
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Stress First Aid
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT04723576 — N/A