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RECRUITING NA

Promoting Improved Functioning Among People Experiencing Stressful Situations

NCT06482567 · View on ClinicalTrials.gov ↗

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Interventions

  • BEHAVIORAL iCOVER
  • BEHAVIORAL Physical Presence with Reassurance

Study Locations (5)

Massachusetts

  • McLean Hospital, Harvard Medical School — Belmont
  • University of Massachusetts Chan Medical School — Worcester

Michigan

  • Henry Ford Health System — Detroit

Missouri

  • Washington University, St. Louis — St Louis

New Jersey

  • Cooper University Health Care — Camden

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2024-08-15
Est. Completion 2027-03
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06482567

The ClinicalTrials.gov registry entry for NCT06482567 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Acute Stress Reaction appearing as the primary indexed condition, and to 2 interventions — of which iCOVER is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06482567 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, Michigan, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06482567 about?

NCT06482567 is a clinical study titled "Promoting Improved Functioning Among People Experiencing Stressful Situations". 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 ...

What is the current status of trial NCT06482567?

This trial is currently recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2024-08-15. Estimated completion is 2027-03.

What conditions does trial NCT06482567 study?

This clinical trial studies the following conditions: Acute Stress Reaction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06482567?

The interventions under investigation include: iCOVER (BEHAVIORAL), Physical Presence with Reassurance (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06482567?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06482567 being conducted?

This trial has 5 study locations across Massachusetts, Michigan, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial