Clinical trial NCT06482567: Promoting Improved Functioning Among People Experiencing Stressful Situations
Official title: Promoting Improved Functioning Among People Experiencing Stressful Situations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Stress Reaction
Keywords: Trauma
Acute Stress Disorder
Acute Stress Reaction
Post Traumatic Stress
Post Traumatic Stress Disorder
Substantial Distress
Dissociation
Distress
Neurocognitive function
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research Acquisition Activity
First posted: 2024-07-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Primary outcomes:
measure: Neurocognitive function at the immediate post-intervention assessment
timeFrame: Immediately post-intervention (5 mins)
Secondary outcomes:
measure: Test My Brain Digit Symbol Matching
timeFrame: 5 mins, 1 hour, 2 days, 7 days post-intervention
measure: Test My Brain Choice Reaction Time Test
timeFrame: 5 mins, 1 hour, 2 days, 7 days post-intervention
measure: Test My Brain Multiple Object Tracking Test
timeFrame: 5 mins, 1 hour, 2 days, 7 days post-intervention
measure: Test My Brain Gradual Onset Continuous Performance Test
timeFrame: 5 mins, 1 hour, 2 days, 7 days post-intervention
measure: Total time spent attempting the four Test My Brain neurocognitive tests
timeFrame: 5 min post-intervention
measure: Subjective Distress assessed via the Subjective Units of Distress (SUDS) scale
timeFrame: 5 mins, 1 hour, 2 days, 7 days post-intervention
measure: Acute Stress Disorder symptoms severity assessed via the Acute Stress Disorder Scale
timeFrame: 2 days, 7 days post-intervention
measure: Sleep Quality assessed using the Insomnia Severity Index
timeFrame: 2 days, 7 days post-intervention
measure: Functional Impairment using the PROMIS Global Health Scale v1.2
timeFrame: 2 days, 7 days post-intervention
measure: Acute Stress Reaction symptoms using the Stress Monitoring and Response Tool (SMART)
timeFrame: 1 hour, 2 days, 7 days post-intervention
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital, Harvard Medical School
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University, St. Louis
state: Missouri
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
Study officials:
affiliation: University of North Carollina at Chapel Hill
name: Samuel McLean, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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