Recruiting

Observational StudyPromoting Improved Functioning Among People Experiencing Stressful Situations

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06482567

Conditions

Acute Stress Reaction

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

iCOVER

Physical Presence with Reassurance

Study Details

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Acute Stress Reaction

Study ID

NCT06482567

Start date

Aug 15, 2024

Status verified date

Dec, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: iCOVER

Individuals randomized to the iCOVER arm will be approached by a trained RA who will obtain assent and perform the iCOVER intervention. After completing the iCOVER protocol, the unblinded RA will leave, and a blinded outcome assessor will return 5 minutes post-intervention to conduct the immediate post-intervention assessment.

active comparator: Physical Presence with Reassurance

A research assistant (RA) will stay with the participant for the length of the iCOVER intervention (in order to ensure matching of the amount of time spent with individuals who receive the iCOVER intervention, which takes 60-120 seconds). During this time, the RA will provide supportive but passive statements. The RA will leave the participant after the length of the iCOVER intervention has elapsed. A separate blinded RA will return 5 minutes post-intervention to conduct the immediate post-intervention assessment.

no intervention: Usual Care

Individuals randomized to usual care will not be approached by research staff until the immediate post-intervention assessment timepoint, at which point a blinded member of the research team will begin the immediate post-intervention assessment.

Interventions

iCOVER

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.

Physical Presence with Reassurance

The RA who performed randomization, initially approached the individual, and obtained assent will stay with the participant for the length of the iCOVER intervention (in order to ensure matching of the amount of time spent with individuals who receive the iCOVER intervention, which takes 60-120 seconds). During this time, the RA will provide supportive but passive statements. The RA will leave the participant after the length of the iCOVER intervention has elapsed. A separate blinded RA will return 5 minutes post-intervention to conduct the immediate post-intervention assessment.

Primary outcome measure

Neurocognitive function at the immediate post-intervention assessment [ Time Frame: Immediately post-intervention (5 mins) ]

Central Contacts and Locations

Central contacts

Jenni Shafer, PhD

919-360-0681 jenni_shafer@med.unc.edu

Allison Britt, BS

919-605-1046 allison_britt@med.unc.edu

Locations

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Abigail Lopes, B.S.

508-421-1226 abigail.lopes1@umassmed.edu

John Haran, MD, PhD

john.haran@umassmed.edu

Principal Investigator:

John Haran, MD, PhD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Brandon Page, B.S.

586-453-2072 bpage4@hfhs.org

Lewandowski, MD

clewand1@hfhs.org

Principal Investigator:

Christopher Lewandowski, MD

Washington University, St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jamie Mills, BS, CCRC

314-273-1382 jamiem@wustl.edu

Stacey House, MD, PhD

staceyhouse@wustl.edu

Principal Investigator:

Stacey House, MD, PhD

Cooper University Health Care

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Lauren Remboski, M.S.

856-571-5344 remboski-lauren@cooperhealth.edu

Christopher W Jones, MD

jones-christopher@cooperhealth.edu

Principal Investigator:

Christopher W Jones, MD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Keywords

Trauma
Acute Stress Disorder
Acute Stress Reaction
Post Traumatic Stress
Post Traumatic Stress Disorder
Substantial Distress
Dissociation
Distress
Neurocognitive function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-12-09.