An interventional study of iCOVER and Physical Presence with Reassurance in Acute Stress Reaction, sponsored by University of North Carolina, Chapel Hill. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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Among 26 studies in Stress Disorders, Traumatic, Acute with a site in United States — 9 open to participants now, 9 under way, none of them phase 3. Stress Disorders, Traumatic, Acute · United States.
Among the 26 studies in Stress Disorders, Traumatic, Acute with a site in United States, this one has the largest planned enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2024, is one of 14 with no phase, and was the 17th registered.
58 studies on the registry are indexed under Stress Disorders, Traumatic, Acute; 15 are open to participants now.
Browse Stress Disorders, Traumatic, Acute studies →9 of the 26 studies in Stress Disorders, Traumatic, Acute with a site in United States are open now. Recruiting first, the newest first:
Walter Reed Army Institute of Research (WRAIR) · Sites in United States
Ages 18–40 · Healthy volunteers
Rhode Island Hospital · Sites in United States
Ages 12–17 · Healthy volunteers
University of North Carolina, Chapel Hill · Sites in United States
Ages 18–65
University of Minnesota · Sites in United States
Ages 21–70 · Healthy volunteers
Walter Reed Army Institute of Research (WRAIR) · Sites in United States
Ages 18–40
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Stress Disorders, Traumatic, Acute studies recruiting now, 2 set no upper age limit and 7 stop at 75 or younger; 1 takes children under 18; 3 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · no healthy volunteers.
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26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 7 · Phase 3 1 · Phase 4 3
First in 2002; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 450 is above the median of 91 across 52 interventional studies indexed under Stress Disorders, Traumatic, Acute.
Median enrollment 73 across the 24 interventional studies, 172 across the 1 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
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1 of 26 have an industry lead sponsor. The 10 most frequent:
University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
University of North Carolina, Chapel Hill has 3 studies filed under Stress Disorders, Traumatic, Acute — fewer than ten, so there is no comparison to draw.
5 of the studies in Stress Disorders, Traumatic, Acute with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06636786University of North Carolina, Chapel HillPrevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) | 2026-11 |
| NCT06482567University of North Carolina, Chapel HillPromoting Improved Functioning Among People Experiencing Stressful Situations | 2027-03 |
| NCT07197476Rhode Island HospitalAdolescent Stress and Substance Intervention Subsequent to Trauma | 2027-04 |
| NCT05427708University of Texas at AustinRespiratory Training in the Treatment of Transdiagnostic Pathological Anxiety | 2027-05 |
| NCT07654777Walter Reed Army Institute of Research (WRAIR)The Efficacy of Vitamin D Supplementation to Sustain Performance Outcomes | 2027-09 |
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Among the 26 studies in Stress Disorders, Traumatic, Acute with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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Exclusion Criteria:
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
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
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.
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.
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.
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).
Time frame: Immediately post-intervention (5 mins)
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 hour, 2 days, 7 days post-intervention
Not enrolling at this site.
Plan to share: 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).
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.
Data sharing details ↗ · dataverse.unc.edu
Started Aug 2024 (actual). Primary completion is estimated for Mar 2027, 31 months after the start.
Of 25 interventional studies with no phase under Stress Disorders, Traumatic, Acute, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 31 months is above that.
How these figures are worked out, and which studies are left out of them.
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Stress Disorders, Traumatic, Acute →
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