Acute Stress ReactioniCOVERNCT06482567
Promoting Improved Functioning Among People Experiencing Stressful Situations
A study testing iCOVER and Physical Presence with Reassurance in people with Acute Stress Reaction, run by University of North Carolina, Chapel Hill at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Stress Reaction
- What is being tested?
- iCOVER and Physical Presence with Reassurance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Aug 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Active, not recruiting
McLean Hospital, Harvard Medical School
Belmont, Massachusetts, 02478
- Recruiting
Cooper University Health Care
Camden, New Jersey, 08103
Lauren Remboski, M.S., 856-571-5344, remboski-lauren@cooperhealth.edu
Christopher W Jones, MD, jones-christopher@cooperhealth.edu
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Brandon Page, B.S., 586-453-2072, bpage4@hfhs.org
Lewandowski, MD, clewand1@hfhs.org
- Recruiting
Washington University, St. Louis
St Louis, Missouri, 63110
Jamie Mills, BS, CCRC, 314-273-1382, jamiem@wustl.edu
Stacey House, MD, PhD, staceyhouse@wustl.edu
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Abigail Lopes, B.S., 508-421-1226, abigail.lopes1@umassmed.edu
John Haran, MD, PhD, john.haran@umassmed.edu
About this study
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
- Being tested
- iCOVER, Physical Presence with Reassurance
- Keywords
- Trauma, Acute Stress Disorder, Acute Stress Reaction, Post Traumatic Stress, Post Traumatic Stress Disorder, Substantial Distress, Dissociation, Distress, Neurocognitive function
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Wounds and Injuries, Stress Disorders, Post-Traumatic, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCOVERBehavioural
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 ReassuranceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iCOVER | Experimental | 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. Receives: Behavioral: iCOVER |
| Physical Presence with Reassurance | Active comparator | 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. Receives: Behavioral: Physical Presence with Reassurance |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive function at the immediate post-intervention assessment
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).
Measured: Immediately post-intervention (5 mins)
Secondary outcomes (10)
Test My Brain Digit Symbol Matching
General cognitive function will be assessed using the Test My Brain Digit Symbol Matching Test. Participants will be asked to match as many symbols and numbers as possible in 90 seconds, using a symbol-number key shown on screen. General cognitive function is assessed via balanced integration scores (BIS), which combine accuracy with mean reaction time for correct responses to 'test' trials
Measured: 5 mins, 1 hour, 2 days, 7 days post-intervention
Test My Brain Choice Reaction Time Test
Procedural reaction time will be assessed using the Test My Brain Choice Reaction Time Test. In this 3-minute task, participants see a set of three arrows, where one arrow is a different color from the rest. The participant presses left or right to indicate the direction of the odd colored arrow. Reaction time is assessed via measuring the mean and median reaction times for correct responses to 'test' trials, as well as through BIS values, which incorporate normalized meanRTc.
Measured: 5 mins, 1 hour, 2 days, 7 days post-intervention
Test My Brain Multiple Object Tracking Test
Visuospatial processing and attention will be assessed will be performed using the Test My Brain Multiple Object Tracking Test. In this two-minute test of visuospatial processing and attention, participants have to track a set of target circles around the screen (amidst a field of distractors) that move at increasing speed with each trial. Once the circles stop moving, participants select which were targets must identify targets instead of distractors. Visuospatial processing and attention is assessed via measuring percent correct for the proportion of total targets correctly identified.
Measured: 5 mins, 1 hour, 2 days, 7 days post-intervention
Test My Brain Gradual Onset Continuous Performance Test
Psychomotor vigilance will be assessed via the Test My Brain Gradual Onset Continuous Performance Test. In this 1-minute task, participants monitor a stream of city and mountain images that rapidly fade from one to the next with no interstimulus interval. Participants are asked to press/touch for each city image and to withhold for each mountain image. Vigilance is assessed via measuring d-prime for identification of each city image, a signal detection-based measure that takes into account both hits and false alarms to provide an unbiased estimate of performance where higher values reflect better performance. Response inhibition is defined as the suppression of actions that are inappropriate in a given context. Response inhibition is assessed using results from the above, by measuring the number of commission errors (failure to withhold responses) where most positive scores reflect more impulsive responding.
Measured: 5 mins, 1 hour, 2 days, 7 days post-intervention
Total time spent attempting the four Test My Brain neurocognitive tests
Length of time individual spends attempting the four neurocognitive tests will be recorded until either discontinuation or completion of tests.
Measured: 5 min post-intervention
Subjective Distress assessed via the Subjective Units of Distress (SUDS) scale
Individuals will be asked verbally to rate their subjective distress at each assessment timepoint on a scale from 0 (totally relaxed) to 100 (highest distress/fear/anxiety you have ever experienced).
Measured: 5 mins, 1 hour, 2 days, 7 days post-intervention
Acute Stress Disorder symptoms severity assessed via the Acute Stress Disorder Scale
Individuals are asked to complete the 19-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; 4= Extremely) that indexes acute stress disorder (ASD).
Measured: 2 days, 7 days post-intervention
Sleep Quality assessed using the Insomnia Severity Index
Individuals are asked to complete the 7-item self-report Insomnia Severity Index (ISI) questionnaire where each item is rated on a 0-4 scale (0= none; 1= mild; 2= moderate; 3= severe; 4= very severe) (that assesses the severity, nature, and impact of insomnia over the past two weeks.
Measured: 2 days, 7 days post-intervention
Functional Impairment using the PROMIS Global Health Scale v1.2
Individuals are asked to complete the 10-item PROMIS Global Health questionnaire where the first 9-items are rated on a 1-5 scale (1= poor; 2= fair; 3= good; 4= very good; 5= excellent) and the one remaining item is rated on a 0-10 scale (0= no pain; 10= worst pain imaginable) that measures a patient's physical, mental, and social health.
Measured: 2 days, 7 days post-intervention
Acute Stress Reaction symptoms using the Stress Monitoring and Response Tool (SMART)
Individuals are asked to complete the 34-item SMART tool where the first 11-items are rated on a 0-10 scale (0= none; 10= severe) and the remaining 23-items are rated on a 0-10 scale (0=none; 10= a great deal) that briefly evaluates core Acute Stress Reaction (ASR) symptom domains including pain, somatic, depressive, concentration, and fatigue symptoms. Question responses will be used to create latent variables for each ASR domain at each timepoint, and ASR symptom severity between groups across timepoints will be assessed.
Measured: 1 hour, 2 days, 7 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start15 Aug 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Acute Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Sponsor
- Investigators
- Samuel McLean, MD, MPH, Principal investigator, University of North Carollina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482567
- Sponsor's protocol ID
- 23-2628
- Other IDs
- CDMRP-TP220430
- Acronym
- iCOVER
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
Publications
Janicki AJ, Frisch SO, Patterson PD, Brown A, Frisch A. Emergency Medicine Residents Experience Acute Stress While Working in the Emergency Department. West J Emerg Med. 2020 Dec 11;22(1):94-100. doi: 10.5811/westjem.2020.10.47641.
PubMed 33439813Hoffmann MC. Assessment of Acute Trauma Exposure Response for FIRE-EMS Personnel. J Appl Meas. 2016;17(4):458-475.
PubMed 28009592Ly V, Roijendijk L, Hazebroek H, Tonnaer C, Hagenaars MA. Incident experience predicts freezing-like responses in firefighters. PLoS One. 2017 Oct 18;12(10):e0186648. doi: 10.1371/journal.pone.0186648. eCollection 2017.
PubMed 29045469Halpern J, Maunder RG, Schwartz B, Gurevich M. The critical incident inventory: characteristics of incidents which affect emergency medical technicians and paramedics. BMC Emerg Med. 2012 Aug 3;12:10. doi: 10.1186/1471-227X-12-10.
PubMed 22862821Marmar CR, Weiss DS, Metzler TJ, Delucchi K. Characteristics of emergency services personnel related to peritraumatic dissociation during critical incident exposure. Am J Psychiatry. 1996 Jul;153(7 Suppl):94-102. doi: 10.1176/ajp.153.7.94.
PubMed 8659646Ringer T, Moller D, Mutsaers A. Distress in Caregivers Accompanying Patients to an Emergency Department: A Scoping Review. J Emerg Med. 2017 Oct;53(4):493-508. doi: 10.1016/j.jemermed.2017.03.028. Epub 2017 May 9.
PubMed 28499745Chang BP, Sumner JA, Haerizadeh M, Carter E, Edmondson D. Perceived clinician-patient communication in the emergency department and subsequent post-traumatic stress symptoms in patients evaluated for acute coronary syndrome. Emerg Med J. 2016 Sep;33(9):626-31. doi: 10.1136/emermed-2015-205473. Epub 2016 Apr 28.
PubMed 27126406Muller HHO, Czwalinna K, Wang R, Lucke C, Lam AP, Philipsen A, Gschossmann JM, Moeller S. Occurence of Post-Traumatic Stress Symptoms, Anxiety and Depression in the Acute Phase of Transient Ischemic Attack and Stroke. Psychiatr Q. 2021 Sep;92(3):905-915. doi: 10.1007/s11126-020-09873-9. Epub 2021 Jan 2.
PubMed 33387257McLean SA, Ressler K, Koenen KC, Neylan T, Germine L, Jovanovic T, Clifford GD, Zeng D, An X, Linnstaedt S, Beaudoin F, House S, Bollen KA, Musey P, Hendry P, Jones CW, Lewandowski C, Swor R, Datner E, Mohiuddin K, Stevens JS, Storrow A, Kurz MC, McGrath ME, Fermann GJ, Hudak LA, Gentile N, Chang AM, Peak DA, Pascual JL, Seamon MJ, Sergot P, Peacock WF, Diercks D, Sanchez LD, Rathlev N, Domeier R, Haran JP, Pearson C, Murty VP, Insel TR, Dagum P, Onnela JP, Bruce SE, Gaynes BN, Joormann J, Miller MW, Pietrzak RH, Buysse DJ, Pizzagalli DA, Rauch SL, Harte SE, Young LJ, Barch DM, Lebois LAM, van Rooij SJH, Luna B, Smoller JW, Dougherty RF, Pace TWW, Binder E, Sheridan JF, Elliott JM, Basu A, Fromer M, Parlikar T, Zaslavsky AM, Kessler R. The AURORA Study: a longitudinal, multimodal library of brain biology and function after traumatic stress exposure. Mol Psychiatry. 2020 Feb;25(2):283-296. doi: 10.1038/s41380-019-0581-3. Epub 2019 Nov 19.
PubMed 31745239Analysis NCfSa. Traffic Safety Facts: 2016 Summary of Motor Vehicle Crashes. 2018:8. Traffic Safety Facts.
Svetlitzky V, Farchi M, Yehuda AB, Adler AB. YaHaLOM: A Rapid Intervention for Acute Stress Reactions in High-Risk Occupations. Military Behavioral Health. 2020;8(2):232-242. doi:10.1080/21635781.2019.1664356
Davis Mr JDS. Diagnosing Changes in Combat Casualty Care. Army. 2018;68(11)
Adler AB, Gutierrez IA. Preparing Soldiers to Manage Acute Stress in Combat: Acceptability, Knowledge and Attitudes. Psychiatry. 2022 Spring;85(1):30-37. doi: 10.1080/00332747.2021.2021598. Epub 2022 Feb 9.
PubMed 35138988
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Improved Functioning Among People Experiencing Stressful Situations
- ClinicalTrials.gov ID
- NCT06482567
- Acronym / sponsor ID
- iCOVER / 23-2628
- Conditions
- Acute Stress Reaction
- Keywords
- Trauma, Acute Stress Disorder, Acute Stress Reaction, Post Traumatic Stress, Post Traumatic Stress Disorder, Substantial Distress, Dissociation, Distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iCOVER | Experimental | Behavioral: iCOVERIndividuals 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. |
| Physical Presence with Reassurance | Active comparator | Behavioral: Physical Presence with ReassuranceA 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (9 listed)
- Known pregnancy
- Prisoner or in custody
- Known history of psychosis or bipolar disorder
- Known or suspected drug intoxication
- Known history of substantial cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCOVERThe 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. | Behavioural | iCOVER |
| Physical Presence with ReassuranceThe 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. | Behavioural | Physical Presence with Reassurance |
Primary outcome
Neurocognitive function at the immediate post-intervention assessment
Time frame: Immediately 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).
10 secondary outcomes
Test My Brain Digit Symbol Matching
Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention
Test My Brain Choice Reaction Time Test
Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention
Test My Brain Multiple Object Tracking Test
Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention
Test My Brain Gradual Onset Continuous Performance Test
Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention
Total time spent attempting the four Test My Brain neurocognitive tests
Time frame: 5 min post-intervention
Subjective Distress assessed via the Subjective Units of Distress (SUDS) scale
Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention
Acute Stress Disorder symptoms severity assessed via the Acute Stress Disorder Scale
Time frame: 2 days, 7 days post-intervention
Sleep Quality assessed using the Insomnia Severity Index
Time frame: 2 days, 7 days post-intervention
Functional Impairment using the PROMIS Global Health Scale v1.2
Time frame: 2 days, 7 days post-intervention
Acute Stress Reaction symptoms using the Stress Monitoring and Response Tool (SMART)
Time frame: 1 hour, 2 days, 7 days post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 33439813Janicki AJ, Frisch SO, Patterson PD, Brown A, Frisch A. Emergency Medicine Residents Experience Acute Stress While Working in the Emergency Department. West J Emerg Med. 2020 Dec 11;22(1):94-100. doi: 10.5811/westjem.2020.10.47641.
- Background: PubMed 28009592Hoffmann MC. Assessment of Acute Trauma Exposure Response for FIRE-EMS Personnel. J Appl Meas. 2016;17(4):458-475.
- Background: PubMed 29045469Ly V, Roijendijk L, Hazebroek H, Tonnaer C, Hagenaars MA. Incident experience predicts freezing-like responses in firefighters. PLoS One. 2017 Oct 18;12(10):e0186648. doi: 10.1371/journal.pone.0186648. eCollection 2017.
- Background: PubMed 22862821Halpern J, Maunder RG, Schwartz B, Gurevich M. The critical incident inventory: characteristics of incidents which affect emergency medical technicians and paramedics. BMC Emerg Med. 2012 Aug 3;12:10. doi: 10.1186/1471-227X-12-10.
- Background: PubMed 8659646Marmar CR, Weiss DS, Metzler TJ, Delucchi K. Characteristics of emergency services personnel related to peritraumatic dissociation during critical incident exposure. Am J Psychiatry. 1996 Jul;153(7 Suppl):94-102. doi: 10.1176/ajp.153.7.94.
- Background: PubMed 28499745Ringer T, Moller D, Mutsaers A. Distress in Caregivers Accompanying Patients to an Emergency Department: A Scoping Review. J Emerg Med. 2017 Oct;53(4):493-508. doi: 10.1016/j.jemermed.2017.03.028. Epub 2017 May 9.
- Background: PubMed 27126406Chang BP, Sumner JA, Haerizadeh M, Carter E, Edmondson D. Perceived clinician-patient communication in the emergency department and subsequent post-traumatic stress symptoms in patients evaluated for acute coronary syndrome. Emerg Med J. 2016 Sep;33(9):626-31. doi: 10.1136/emermed-2015-205473. Epub 2016 Apr 28.
- Background: PubMed 33387257Muller HHO, Czwalinna K, Wang R, Lucke C, Lam AP, Philipsen A, Gschossmann JM, Moeller S. Occurence of Post-Traumatic Stress Symptoms, Anxiety and Depression in the Acute Phase of Transient Ischemic Attack and Stroke. Psychiatr Q. 2021 Sep;92(3):905-915. doi: 10.1007/s11126-020-09873-9. Epub 2021 Jan 2.
- Background: PubMed 31745239McLean SA, Ressler K, Koenen KC, Neylan T, Germine L, Jovanovic T, Clifford GD, Zeng D, An X, Linnstaedt S, Beaudoin F, House S, Bollen KA, Musey P, Hendry P, Jones CW, Lewandowski C, Swor R, Datner E, Mohiuddin K, Stevens JS, Storrow A, Kurz MC, McGrath ME, Fermann GJ, Hudak LA, Gentile N, Chang AM, Peak DA, Pascual JL, Seamon MJ, Sergot P, Peacock WF, Diercks D, Sanchez LD, Rathlev N, Domeier R, Haran JP, Pearson C, Murty VP, Insel TR, Dagum P, Onnela JP, Bruce SE, Gaynes BN, Joormann J, Miller MW, Pietrzak RH, Buysse DJ, Pizzagalli DA, Rauch SL, Harte SE, Young LJ, Barch DM, Lebois LAM, van Rooij SJH, Luna B, Smoller JW, Dougherty RF, Pace TWW, Binder E, Sheridan JF, Elliott JM, Basu A, Fromer M, Parlikar T, Zaslavsky AM, Kessler R. The AURORA Study: a longitudinal, multimodal library of brain biology and function after traumatic stress exposure. Mol Psychiatry. 2020 Feb;25(2):283-296. doi: 10.1038/s41380-019-0581-3. Epub 2019 Nov 19.
- BackgroundAnalysis NCfSa. Traffic Safety Facts: 2016 Summary of Motor Vehicle Crashes. 2018:8. Traffic Safety Facts.
- BackgroundSvetlitzky V, Farchi M, Yehuda AB, Adler AB. YaHaLOM: A Rapid Intervention for Acute Stress Reactions in High-Risk Occupations. Military Behavioral Health. 2020;8(2):232-242. doi:10.1080/21635781.2019.1664356
- BackgroundDavis Mr JDS. Diagnosing Changes in Combat Casualty Care. Army. 2018;68(11)
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel McLean, MD, MPH principal investigator
University of North Carollina at Chapel Hill
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCOVER and Physical Presence with Reassurance in people with Acute Stress Reaction, run by University of North Carolina, Chapel Hill at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenni Shafer, PhD (919-360-0681, jenni_shafer@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive function at the immediate post-intervention assessment (time frame: Immediately post-intervention (5 mins)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06482567, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.