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Study on Promoting Improved Functioning Among People Experiencing Stressful Situations

This study is testing a behavioral intervention called iCOVER to see if it can quickly help people who are experiencing an Acute Stress Reaction (ASR), which is a strong emotional or physical response to a stressful event. The iCOVER method involves six steps, including connecting with the person and offering commitment. Another group will receive "Physical Presence with Reassurance," where a staff member stays with them. The study aims to enroll 450 adults between 18 and 50 years old who are in the emergency department and showing signs of distress. Researchers will measure how well participants' brain functions (neurocognitive function) immediately after the intervention. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 450 participants.
What's involved
Participants will receive either the iCOVER intervention or physical presence with reassurance, which takes 60-120 seconds. Neurocognitive function will be assessed immediately after the intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed immediately after the intervention (within 5 minutes).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06482567

Promoting Improved Functioning Among People Experiencing Stressful Situations

Recruiting
NAAges 18–50InterventionalPrevention
University of North Carolina, Chapel Hill
~450 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:iCOVERPhysical Presence with Reassurance

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurocognitive function at the immediate post-intervention assessment
Measured over Immediately post-intervention (5 mins)

Conditions

Acute Stress Reaction

Explore related trials

Acute Stress DisorderDissociation - mental defense mechanismPost-Traumatic Stress DisorderStress

Where it's being run

5 sites across 4 states
Massachusetts2
Michigan1
Missouri1
New Jersey1

Study leadership

  • Samuel McLean, MD, MPH · PRINCIPAL_INVESTIGATOR · University of North Carollina at Chapel Hill

Who to contact

Jenni Shafer, PhD
[email protected]
919-360-0681
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 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

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)

What this trial measures

  • Neurocognitive function at the immediate post-intervention assessmentImmediately post-intervention (5 mins)

    To assess acute neurocognitive function, a suite of four brief neurocognitive tasks will be employed, and the primary outcome will consist of overall performance across all four tasks as assessed jointly using a multivariate linear mixed model. These four tasks each assess an aspect of neurocognitive function essential to warfighting during times of intense stress: generalized cognitive function using the Test My Brain Digit Symbol Matching Test (measuring balanced integration scores (BIS) which combine accuracy with mean reaction time for correct responses to 'test' trials), procedural reaction using the Test My Brain Choice Reaction Time Test (measuring the mean and median reaction times for correct responses to 'test' trials, as well as through BIS values, which incorporate normalized meanRTc.), visual search and visual change detection using the Test My Brain Multiple Object Tracking Test (measuring percent correct for the proportion of total targets correctly identified).