Promoting Improved Functioning Among People Experiencing Stressful Situations
NCT Number: NCT06482567
Acronym: iCOVER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Stress Reaction
Interventions: BEHAVIORAL: iCOVER|BEHAVIORAL: Physical Presence with Reassurance
Sponsor: University of North Carolina, Chapel Hill
Collaborators: U.S. Army Medical Research Acquisition Activity
Sex: ALL
Age: ADULT
Enrollment: 450
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2027-03
Locations: McLean Hospital, Harvard Medical School, Belmont, Massachusetts, 02478, United States|University of Massachusetts Chan Medical School, Worcester, Massachusetts, 01655, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Washington University, St. Louis, Saint Louis, Missouri, 63110, United States|Cooper University Health Care, Camden, New Jersey, 08103, United States

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Primary Outcome Measures: Neurocognitive function at the immediate post-intervention assessment, To assess acute neurocognitive function, a suite of four brief neurocognitive tasks will be employed, and the primary outcome will consist of overall performance across all four tasks as assessed jointly using a multivariate linear mixed model. These four tasks each assess an aspect of neurocognitive function essential to warfighting during times of intense stress: generalized cognitive function using the Test My Brain Digit Symbol Matching Test (measuring medianRTc for the median reaction time of correct responses to 'test' trials), procedural reaction using the Test My Brain Choice Reaction Time Test (measuring medianRTc for the median reaction time of correct responses to 'test' trials), visual search and visual change detection using the Test My Brain Multiple Object Tracking Test (measuring percent correct for the proportion of total targets correctly identified)., Immediately post-intervention (5 mins)
Secondary Outcome Measures: Test My Brain Digit Symbol Matching, General cognitive function will be assessed using the Test My Brain Digit Symbol Matching Test. Participants will be asked to match as many symbols and numbers as possible in 90 seconds, using a symbol-number key shown on screen. General cognitive function is assessed via measuring medianRTc for the median reaction time of correct responses to 'test' trials., 5 mins, 1 hour, 2 days, 7 days post-intervention|Test My Brain Choice Reaction Time Test, Procedural reaction time will be assessed using the Test My Brain Choice Reaction Time Test. In this 3-minute task, participants see a set of three arrows, where one arrow is a different color from the rest. The participant presses left or right to indicate the direction of the odd colored arrow. Reaction time is assessed via measuring medianRTc for the median reaction time of correct responses to 'test' trials., 5 mins, 1 hour, 2 days, 7 days post-intervention|Test My Brain Multiple Object Tracking Test, Visuospatial processing and attention will be assessed will be performed using the Test My Brain Multiple Object Tracking Test. In this two-minute test of visuospatial processing and attention, participants have to track a set of target circles around the screen (amidst a field of distractors) that move at increasing speed with each trial. Once the circles stop moving, participants select which were targets must identify targets instead of distractors. Visuospatial processing and attention is assessed via measuring percent correct for the proportion of total targets correctly identified., 5 mins, 1 hour, 2 days, 7 days post-intervention|Test My Brain Gradual Onset Continuous Performance Test, Psychomotor vigilance will be assessed via the Test My Brain Gradual Onset Continuous Performance Test. In this 1-minute task, participants monitor a stream of city and mountain images that rapidly fade from one to the next with no interstimulus interval. Participants are asked to press/touch for each city image and to withhold for each mountain image. Vigilance is assessed via measuring d-prime for identification of each city image, a signal detection-based measure that takes into account both hits and false alarms to provide an unbiased estimate of performance where higher values reflect better performance. Response inhibition is defined as the suppression of actions that are inappropriate in a given context. Response inhibition is assessed using results from the above, by measuring the number of commission errors (failure to withhold responses) where most positive scores reflect more impulsive responding., 5 mins, 1 hour, 2 days, 7 days post-intervention|Total time spent attempting the four Test My Brain neurocognitive tests, Length of time individual spends attempting the four neurocognitive tests will be recorded until either discontinuation or completion of tests., 5 min post-intervention|Subjective Distress assessed via the Subjective Units of Distress (SUDS) scale, Individuals will be asked verbally to rate their subjective distress at each assessment timepoint on a scale from 0 (totally relaxed) to 100 (highest distress/fear/anxiety you have ever experienced)., 5 mins, 1 hour, 2 days, 7 days post-intervention|Acute Stress Disorder symptoms severity assessed via the Acute Stress Disorder Scale, Individuals are asked to complete the 19-item Acute Stress Disorder Scale (ASDS) self-report inventory where each item is rated on a 5-point scale (0= Not at all; 1= A little bit; 2= Moderately; 3= Quite a bit; 4= Extremely) that indexes acute stress disorder (ASD)., 2 days, 7 days post-intervention|Sleep Quality assessed using the Insomnia Severity Index, Individuals are asked to complete the 7-item self-report Insomnia Severity Index (ISI) questionnaire where each item is rated on a 0-4 scale (0= none; 1= mild; 2= moderate; 3= severe; 4= very severe) (that assesses the severity, nature, and impact of insomnia over the past two weeks., 2 days, 7 days post-intervention|Functional Impairment using the PROMIS Global Health Scale v1.2, Individuals are asked to complete the 10-item PROMIS Global Health questionnaire where the first 9-items are rated on a 1-5 scale (1= poor; 2= fair; 3= good; 4= very good; 5= excellent) and the one remaining item is rated on a 0-10 scale (0= no pain; 10= worst pain imaginable) that measures a patient's physical, mental, and social health., 2 days, 7 days post-intervention|Acute Stress Reaction symptoms using the Stress Monitoring and Response Tool (SMART), Individuals are asked to complete the 34-item SMART tool where the first 11-items are rated on a 0-10 scale (0= none; 10= severe) and the remaining 23-items are rated on a 0-10 scale (0=none; 10= a great deal) that briefly evaluates core Acute Stress Reaction (ASR) symptom domains including pain, somatic, depressive, concentration, and fatigue symptoms. Question responses will be used to create latent variables for each ASR domain at each timepoint, and ASR symptom severity between groups across timepoints will be assessed., 1 hour, 2 days, 7 days post-intervention