Actively Recruiting
Promoting Improved Functioning Among People Experiencing Stressful Situations
Led by University of North Carolina, Chapel Hill · Updated on 2025-12-09
450
Participants Needed
5
Research Sites
132 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
U
U.S. Army Medical Research Acquisition Activity
Collaborating Sponsor
AI-Summary
What this Trial Is About
The iCOVER intervention was developed to rapidly restore functioning in individuals experiencing an Acute Stress Reaction (ASR). iCOVER is undergoing widespread adoption but has not been tested for efficacy. iCOVER was designed to be administered by peers, paraprofessionals, or medical personnel in 60-120 seconds, including in military operational environments. The term iCOVER is an acronym that summarizes the six specific steps of the intervention: (1) identify that an individual is experiencing an ASR; (2) Connect with the individual through word, eye contact, and physical touch to draw them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish order of events - briefly review what has happened, what is happening, and what will happen to orient the individual; and (6) Request action to re-engage the individual in purposeful behavior. Participants will be randomly assigned to one of three groups: iCOVER, usual care, or physical presence with reassurance. Investigators have elected to use two different control conditions, in order to examine the reliability of the iCOVER intervention in comparison with two typical responses to individuals experiencing an ASR (i.e., physical presence with reassurance, no specific treatment).
CONDITIONS
Official Title
Promoting Improved Functioning Among People Experiencing Stressful Situations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years (or appears to be in this range)
- Present in the emergency department as a patient or loved one of a patient
- If a patient, expected to be discharged home after emergency department evaluation
- Exhibiting visible signs of distress (Richmond Agitation and Sedation Scale +1 to +3) or awake and alert but with reduced responsiveness
- Likely able to speak English
You will not qualify if you...
- Known pregnancy
- Prisoner or in custody
- Known history of psychosis or bipolar disorder
- Known or suspected drug intoxication
- Known history of substantial cognitive impairment
- Known or suspected altered mental status due to traumatic brain injury
- Known active psychosis, suicidal ideation, or homicidal ideation
- Unable to use both hands (e.g., due to sprain)
- Any other condition that the site investigator believes would make the individual unsuitable or non-compliant with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
McLean Hospital, Harvard Medical School
Belmont, Massachusetts, United States, 02478
Active, Not Recruiting
2
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
4
Washington University, St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Cooper University Health Care
Camden, New Jersey, United States, 08103
Actively Recruiting
Research Team
J
Jenni Shafer, PhD
CONTACT
A
Allison Britt, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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