Intervention to help people cope with acute stress reactions
Promoting Improved Functioning Among People Experiencing Stressful Situations
This study tests a new quick support method called iCOVER to help people dealing with acute stress reactions feel better and get back to normal after a stressful event.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 5 sites (Belmont, Massachusetts and 4 other locations) |
| Trial ID | NCT06482567 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 50 who are in an emergency department and showing visible signs of distress.
Not a fit: Patients with known pregnancy, severe mental health conditions, or those unable to comply with the intervention due to physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the immediate coping mechanisms of individuals facing acute stress, leading to better overall mental health outcomes.
How similar studies have performed: While the iCOVER intervention is undergoing its first efficacy testing, similar peer-supported interventions have shown promise in managing acute stress in various settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Belmont, Massachusetts and 4 other locations
- McLean Hospital, Harvard Medical School — Belmont, Massachusetts, United States (Active_not_recruiting)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.