NCT06482567 Promoting Improved Functioning Among People Experiencing Stressful Situations
| NCT ID | NCT06482567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Acute Stress Reaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2024-08-15 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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).
Eligibility 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)
Contact & Investigator
Samuel McLean, MD, MPH
PRINCIPAL INVESTIGATOR
University of North Carollina at Chapel Hill
Frequently Asked Questions
Who can join the NCT06482567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Acute Stress Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06482567 currently recruiting?
Yes, NCT06482567 is actively recruiting participants. Contact the research team at jenni_shafer@med.unc.edu for enrollment information.
Where is the NCT06482567 trial being conducted?
This trial is being conducted at Belmont, United States, Worcester, United States, Detroit, United States, St Louis, United States and 1 additional location.
Who is sponsoring the NCT06482567 clinical trial?
NCT06482567 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Samuel McLean, MD, MPH at University of North Carollina at Chapel Hill. The trial plans to enroll 450 participants.