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NCT06482567NARecruiting

Promoting Improved Functioning Among People Experiencing Stressful Situations

University of North Carolina, Chapel Hill

Start Date

8/15/2024

Completion Date

3/1/2027

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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).

Eligibility Criteria

Age Range: 18 years to 50 years

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)

Interventions

BEHAVIORAL

iCOVER

BEHAVIORAL

Physical Presence with Reassurance

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Conditions

Acute Stress Reaction

Locations

McLean Hospital, Harvard Medical School

Belmont, Massachusetts 02478

United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Washington University, St. Louis

St Louis, Missouri 63110

United States

Cooper University Health Care

Camden, New Jersey 08103

United States