Promoting Improved Functioning Among People Experiencing Stressful Situations (iCOVER)

December 8, 2025 updated by: University of North Carolina, Chapel Hill

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Active, not recruiting
        • McLean Hospital, Harvard Medical School
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Chan Medical School
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Haran, MD, PhD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Lewandowski, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University, St. Louis
        • Principal Investigator:
          • Stacey House, MD, PhD
        • Contact:
        • Contact:
    • New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately post-intervention (5 mins)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test My Brain Multiple Object Tracking Test
Time Frame: 5 mins, 1 hour, 2 days, 7 days post-intervention
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.
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
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.
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
Length of time individual spends attempting the four neurocognitive tests will be recorded until either discontinuation or completion of tests.
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
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).
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
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).
2 days, 7 days post-intervention
Sleep Quality assessed using the Insomnia Severity Index
Time Frame: 2 days, 7 days post-intervention
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.
2 days, 7 days post-intervention
Functional Impairment using the PROMIS Global Health Scale v1.2
Time Frame: 2 days, 7 days post-intervention
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.
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
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.
1 hour, 2 days, 7 days post-intervention
Test My Brain Digit Symbol Matching
Time Frame: 5 mins, 1 hour, 2 days, 7 days post-intervention
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
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
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.
5 mins, 1 hour, 2 days, 7 days post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

U.S. Army Medical Research Acquisition Activity

Investigators

  • Principal Investigator: Samuel McLean, MD, MPH, University of North Carollina at Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-2628
  • CDMRP-TP220430 (Other Grant/Funding Number: USAMRAA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

Beginning 12 months following publication and continuing for 36 months

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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