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NCT06482567 · ClinicalTrials.gov registry record · NA
Promoting Improved Functioning Among People Experiencing Stressful Situations
A NA study of Acute Stress Reaction, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 5
- Study locations
NCT06482567 is a NA study of Acute Stress Reaction that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 450 participants, above the 138-participant average among 3 other Acute Stress Reaction trials with a reported enrollment target (226% higher). The trial reports 5 study locations across 4 states.
The verdict
NCT06482567, a NA study of Acute Stress Reaction, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 5
- Study locations
Study Summary
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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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 Studied
Interventions
- BEHAVIORAL iCOVER
- BEHAVIORAL Physical Presence with Reassurance
Study Locations (5)
Massachusetts
- McLean Hospital, Harvard Medical School - Belmont
- University of Massachusetts Chan Medical School - Worcester
Michigan
- Henry Ford Health System - Detroit
Missouri
- Washington University, St. Louis - St Louis
New Jersey
- Cooper University Health Care - Camden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2027-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06482567
The ClinicalTrials.gov registry entry for NCT06482567 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 138-participant average among 3 other Acute Stress Reaction trials with a reported enrollment target (226% higher). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Stress Reaction appearing as the primary indexed condition, and to 2 interventions - of which iCOVER is the first listed.
NCT06482567 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, Michigan, Missouri.
Frequently Asked Questions
What is clinical trial NCT06482567 about?
NCT06482567 is a clinical study titled "Promoting Improved Functioning Among People Experiencing Stressful Situations". 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 ...
What is the current status of trial NCT06482567?
This trial is currently recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2024-08-15. Estimated completion is 2027-03.
What conditions does trial NCT06482567 study?
This clinical trial studies the following conditions: Acute Stress Reaction.
What interventions are being tested in trial NCT06482567?
The interventions under investigation include: iCOVER (BEHAVIORAL), Physical Presence with Reassurance (BEHAVIORAL).
Who is sponsoring clinical trial NCT06482567?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06482567 being conducted?
This trial has 5 study locations across Massachusetts, Michigan, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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