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Behavioral Intervention

iCOVER for Acute Stress Disorder (iCOVER Trial)

N/A

Recruiting

Led By Samuel McLean, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Exhibiting visible signs of distress Richmond Agitation and Sedation Scale ((RASS) (+1 to +3)) or dissociation (awake and alert but reduced responsiveness)

Be between 18 and 65 years old

Must not have

Known or suspected altered mental status due to traumatic brain injury

Known active psychosis, suicidal ideation, or homicidal ideation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 mins, 1 hour, 2 days, 7 days post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new intervention called iCOVER that aims to help individuals experiencing an Acute Stress Reaction. iCOVER involves six steps that can be administered quickly by peers, paraprofessionals

Who is the study for?

This trial is for individuals experiencing an Acute Stress Reaction (ASR), such as those with acute traumatic stress disorder or acute stress disorder. Participants should be in a situation where they can receive one of the interventions and have not received iCOVER before.

What is being tested?

The study tests the 'iCOVER' intervention against two controls: usual care, and physical presence with reassurance. iCOVER involves a quick, structured response to help someone in distress by connecting, offering support, verifying facts, establishing order of events, and requesting action.

What are the potential side effects?

Since iCOVER is a non-medical intervention involving communication and reassurance techniques rather than drugs or medical procedures, it's not expected to have traditional side effects. However, its effectiveness compared to standard care needs evaluation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I show clear signs of distress or seem disconnected but awake.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have changes in my mental state due to a head injury.

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I do not have active psychosis or thoughts of suicide or harming others.

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I cannot use both of my hands due to an injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 mins, 1 hour, 2 days, 7 days post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 mins, 1 hour, 2 days, 7 days post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 mins, 1 hour, 2 days, 7 days post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neurocognitive function at the immediate post-intervention assessment

Secondary study objectives

Acute Stress Disorder symptoms severity assessed via the Acute Stress Disorder Scale

Acute Stress Reaction symptoms using the Stress Monitoring and Response Tool (SMART)

Functional Impairment using the PROMIS Global Health Scale v1.2

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: iCOVERExperimental Treatment1 Intervention

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.

Group II: Physical Presence with ReassuranceActive Control1 Intervention

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.

Group III: Usual CareActive Control1 Intervention

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.

0 / 4Eligibility criteria met