RecruitingNot ApplicableNCT06482567

Promoting Improved Functioning Among People Experiencing Stressful Situations

Sponsor

University of North Carolina, Chapel Hill

Enrollment

450 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Stress Reaction

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brief, non-drug intervention to reduce distress in people who are in the emergency department — either as a patient or as a family member of someone being treated. Researchers want to see if a short calming technique can help people who are visibly stressed or in a dissociative state. **You may be eligible if...** - You are 18–50 years old - You are in the emergency department as a patient expected to be discharged home, or as a loved one of a patient - You are showing visible signs of distress or emotional shutdown (reduced responsiveness while awake) - You can speak and understand English **You may NOT be eligible if...** - You are pregnant - You are a prisoner or in custody - You have a known history of psychosis or bipolar disorder - You are suspected to be under the influence of drugs or alcohol - You have significant cognitive impairment or brain injury - You currently have thoughts of harming yourself or others Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALiCOVER

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.

BEHAVIORALPhysical Presence with Reassurance

The RA who performed randomization, initially approached the individual, and obtained assent 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.