Promoting Improved Functioning Among People Experiencing Stressful Situations

NCT06482567 | Recruiting

• 2 other identifiers: 23-2628CDMRP-TP220430
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 5

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately post-intervention (5 mins)

Secondary Outcomes (10)

• Test My Brain Digit Symbol Matching

  5 mins, 1 hour, 2 days, 7 days post-intervention

• Test My Brain Choice Reaction Time Test

  5 mins, 1 hour, 2 days, 7 days post-intervention

• Test My Brain Multiple Object Tracking Test

  5 mins, 1 hour, 2 days, 7 days post-intervention

• Test My Brain Gradual Onset Continuous Performance Test

  5 mins, 1 hour, 2 days, 7 days post-intervention

• Total time spent attempting the four Test My Brain neurocognitive tests

  5 min post-intervention

Study Arms (3)

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.

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.

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.

Interventions

iCOVER BEHAVIORAL

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.

iCOVER

Physical Presence with Reassurance BEHAVIORAL

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.

Physical Presence with Reassurance

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• U.S. Army Medical Research Acquisition Activity: collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (5)

McLean Hospital, Harvard Medical School

Belmont, Massachusetts, 02478, United States

ACTIVE NOT RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Washington University, St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Cooper University Health Care

Camden, New Jersey, 08103, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 33439813 BACKGROUND

• Hoffmann MC. Assessment of Acute Trauma Exposure Response for FIRE-EMS Personnel. J Appl Meas. 2016;17(4):458-475.

  PMID: 28009592 BACKGROUND

• Ly 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.

  PMID: 29045469 BACKGROUND

• Halpern 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.

  PMID: 22862821 BACKGROUND

• Marmar 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.

  PMID: 8659646 BACKGROUND

• Ringer 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.

  PMID: 28499745 BACKGROUND

• Chang 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.

  PMID: 27126406 BACKGROUND

• Muller 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.

  PMID: 33387257 BACKGROUND

• McLean 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.

  PMID: 31745239 BACKGROUND

• Analysis NCfSa. Traffic Safety Facts: 2016 Summary of Motor Vehicle Crashes. 2018:8. Traffic Safety Facts.

  BACKGROUND

• 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

  BACKGROUND

• Davis Mr JDS. Diagnosing Changes in Combat Casualty Care. Army. 2018;68(11)

  BACKGROUND

• 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.

  PMID: 35138988 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Wounds and Injuries; Stress Disorders, Post-Traumatic; Dissociative Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Samuel McLean, MD, MPH

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenni Shafer, PhD

CONTACT

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

Allison Britt, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 12 months following publication and continuing for 36 months
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (5)