Viewing Study NCT06482567



Ignite Creation Date: 2024-07-17 @ 11:01 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06482567
Status: RECRUITING
Last Update Posted: 2024-07-01
First Post: 2024-06-25

Brief Title: Promoting Improved Functioning Among People Experiencing Stressful Situations
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: Promoting Improved Functioning Among People Experiencing Stressful Situations
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: iCOVER
Brief 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draw them back to the present moment 3 Offer commitment so that the individual feels less psychologically isolated and withdrawn eg Im right here with you 4 Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity 5 Establish order of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 ie physical presence with reassurance no specific treatment
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
HT94252320032 OTHER_GRANT None None