Promoting Improved Functioning Among People Experiencing Stressful Situations (iCOVER)

University of North Carolina (UNC)

Status: Enrolling

Conditions: Acute Stress Reaction

Treatments: Behavioral: iCOVER; Behavioral: Physical Presence with Reassurance

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06482567

23-2628

CDMRP-TP220430 (Other Grant/Funding Number)

Details and patient eligibility

About

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups

iCOVER

Experimental group

Description:

Individuals randomized to the iCOVER arm will be approached by a trained RA who will obtain assent and perform the iCOVER intervention. After completing the iCOVER protocol, the unblinded RA will leave, and a blinded outcome assessor will return 5 minutes post-intervention to conduct the immediate post-intervention assessment.

Treatment:

Behavioral: iCOVER

Physical Presence with Reassurance

Active Comparator group

Description:

A research assistant (RA) will stay with the participant for the length of the iCOVER intervention (in order to ensure matching of the amount of time spent with individuals who receive the iCOVER intervention, which takes 60-120 seconds). During this time, the RA will provide supportive but passive statements. The RA will leave the participant after the length of the iCOVER intervention has elapsed. A separate blinded RA will return 5 minutes post-intervention to conduct the immediate post-intervention assessment.

Treatment:

Behavioral: Physical Presence with Reassurance

Usual Care

No Intervention group

Description:

Individuals randomized to usual care will not be approached by research staff until the immediate post-intervention assessment timepoint, at which point a blinded member of the research team will begin the immediate post-intervention assessment.