Promoting Improved Functioning Among People Experiencing Stressful Situations

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to test a new approach called iCOVER, which aims to help people who are experiencing an Acute Stress Reaction (ASR) regain their ability to function in stressful situations. The iCOVER method involves six simple steps, such as connecting with the person, asking questions to engage their mind, and helping them understand what has happened and what will happen next. This intervention can be quickly administered by peers or medical staff in just one to two minutes, making it suitable for use in emergency settings or even in military environments.

To participate in this trial, individuals must be between 18 and 50 years old, either as a patient or a loved one in the emergency department, and show visible signs of distress. Those who meet these criteria may be randomly assigned to receive the iCOVER intervention, usual care, or just reassurance from someone present. Participants can expect to be part of a study that could improve how people cope with stress after traumatic events, as researchers gather important information about the effectiveness of this new method.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 18 years and ≤ 50 years of age (if age not known, appears to be)
• • In the emergency department as a patient or loved one of a patient
• • If a patient, anticipated to be discharged to home from the emergency department after evaluation
• • Exhibiting visible signs of distress Richmond Agitation and Sedation Scale ((RASS) (+1 to +3)) or dissociation (awake and alert but reduced responsiveness)
• • Likely able to speak English
• Exclusion Criteria:
• • 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 history or condition that would, in the site investigator's judgement, indicate that the individual would very likely be non-compliant with the study or unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger participant)