Intervention to help people cope with acute stress reactions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The iCOVER intervention aims to quickly restore functioning in individuals experiencing Acute Stress Reactions (ASR) by utilizing a structured six-step approach. This intervention can be administered by peers, paraprofessionals, or medical personnel in a matter of seconds, making it suitable for emergency situations, including military environments. The steps involve identifying distress, connecting with the individual, offering reassurance, verifying facts, and establishing a timeline of events to help orient the person. The efficacy of iCOVER is being tested for the first time in this clinical trial.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Massachusetts Chan Medical School
  Worcester, Massachusetts, United States Recruiting
• Henry Ford Health System
  Detroit, Michigan, United States Recruiting
• Washington University, St. Louis
  St Louis, Missouri, United States Recruiting
• Cooper University Health Care
  Camden, New Jersey, United States Recruiting
• McLean Hospital, Harvard Medical School
  Belmont, Massachusetts, United States Active not recruiting

Study contacts

• Principal investigator: Samuel McLean, MD, MPH — University of North Carollina at Chapel Hill
• Study coordinator: Jenni Shafer, PhD
• Email: jenni_shafer@med.unc.edu
• Phone: 919-360-0681

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.