Promoting Improved Functioning Among People Experiencing Stressful Situations

Last updated: December 2, 2024
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

iCOVER

Physical Presence with Reassurance

Clinical Study ID

NCT06482567
23-2628
CDMRP-TP220430
HT94252320032
  • Ages 18-50
  • All Genders

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Eligibility Criteria

Inclusion

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 departmentafter 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

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 orunsuitable for the study (e.g. might interfere with the study, confoundinterpretation, or endanger participant)

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: iCOVER
Phase:
Study Start date:
August 15, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • McLean Hospital, Harvard Medical School

    Belmont, Massachusetts 02478
    United States

    Site Not Available

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Washington University, St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Cooper University Health Care

    Camden, New Jersey 08103
    United States

    Active - Recruiting

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