iCOVER for Acute Stress Disorder

(iCOVER Trial)

Recruiting at 4 trial locations

Overseen By Allison Britt, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Pregnancy, Psychosis, Bipolar, Drug intoxication, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the iCOVER treatment different from other treatments for acute stress disorder?

iCOVER is unique because it is a training program designed to help individuals recognize and respond to acute stress reactions using a simple, 6-step procedure, rather than a medication or traditional therapy. It focuses on improving knowledge and confidence in handling stress, particularly in high-risk environments like military settings, which is different from standard treatments that often involve medication or cognitive behavior therapy. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment iCOVER for Acute Stress Disorder?

The iCOVER training has been shown to improve knowledge and confidence in handling acute stress reactions among military personnel, suggesting it may help teams support each other effectively during stressful situations. ^{2 3 4 5 6}

Who Is on the Research Team?

Samuel McLean, MD, MPH

Principal Investigator

University of North Carollina at Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I expect to go home after my emergency department visit.

In the emergency department as a patient or loved one of a patient

I can speak English well enough to communicate.

Exclusion Criteria

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

Known pregnancy

Prisoner or in custody

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants receive the iCOVER intervention or are assigned to control conditions (usual care or physical presence with reassurance).

Immediate (60-120 seconds)

1 visit (in-person)

Immediate Post-Intervention Assessment

Neurocognitive function is assessed immediately after the intervention using a suite of brief neurocognitive tasks.

5 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple timepoints.

7 days

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• iCOVER

Trial Overview 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.

How Is the Trial Designed?

Group I: iCOVER Experimental Treatment 1 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 Reassurance Active Control 1 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 Care Active Control 1 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.

iCOVER is already approved in United States, Canada, United Kingdom for the following indications:

Approved in United States as iCOVER for:

• Acute Stress Reaction (ASR) management

Approved in Canada as iCOVER for:

• ASR management

Approved in United Kingdom as iCOVER for:

• ASR management

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

U.S. Army Medical Research Acquisition Activity

Collaborator

Trials

26

Recruited

10,500+

Published Research Related to This Trial

In a study of 45 trauma survivors with acute stress disorder, those who received prolonged exposure therapy (14%) or a combination of prolonged exposure and anxiety management (20%) had significantly lower rates of developing PTSD compared to those who received supportive counseling (56%).

At a 6-month follow-up, the prolonged exposure group (15%) and the combination group (23%) continued to show lower PTSD rates than the supportive counseling group (67%), indicating that early cognitive behavior therapy, particularly prolonged exposure, is effective in preventing chronic PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating acute stress disorder: an evaluation of cognitive behavior therapy and supportive counseling techniques. Bryant, RA., Sackville, T., Dang, ST., et al.[2018]

The iCOVER training program was well-accepted by military personnel and significantly improved their knowledge and performance in recognizing and responding to acute stress reactions, with knowledge scores increasing from an average of 3.33 to 5.15 after training.

Participants who underwent the in-person practical exercise (iCOVER Standard) demonstrated better performance in live-action scenarios compared to those who used computer simulations (iCOVER Tech), indicating that hands-on training may be more effective for skill acquisition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid response to acute stress reaction: Pilot test of iCOVER training for military units. Adler, AB., Start, AR., Milham, L., et al.[2020]

iCOVER training significantly improved soldiers' knowledge and attitudes regarding managing acute stress reactions, with 129 out of 146 soldiers participating in the evaluation before their deployment to combat.

Participants rated the training highly for its usefulness and relevance, and reported increased confidence in handling acute stress reactions, as well as a reduction in stigma associated with such reactions after completing the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing Soldiers to Manage Acute Stress in Combat: Acceptability, Knowledge and Attitudes. Adler, AB., Gutierrez, IA.[2022]

Cognitive-behavioral interventions have shown positive effects for treating Acute Stress Disorder (ASD), while psychodynamic therapy, cognitive-behavioral therapy, and EMDR are promising for Posttraumatic Stress Disorder (PTSD).

Selective Serotonin Reuptake Inhibitors (SSRIs) are the most studied and effective medications for both ASD and PTSD, offering a broader therapeutic effect and better tolerance compared to tricyclic antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic possibilities after traumatic experiences]. Kapfhammer, HP.[2008]

A new preclinical model using adult male rats exposed to multiple traumatic stressors (predator exposure, underwater trauma, and inescapable shock) effectively mimics behavioral disturbances seen in Acute Stress Reactions (ASRs) and Combat and Operational Stress Reactions (COSRs) relevant to military trauma.

The study found that the combination of three stressors led to the most significant behavioral deficits, indicating that using both physical and psychological stressors can better represent the complexities of traumatic stress experienced by soldiers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Animal Model of Military-Relevant Traumatic Stress. Henschen, D., Swift, K., Taylor, R., et al.[2023]

In a study of 32 patients with cardiovascular diseases and stress-related disorders, afobazole demonstrated significant therapeutic efficacy, with 70% of participants responding positively to treatment over 6 weeks.

Patients began to show improvement in anxiety symptoms as early as the first week, with continued enhancement noted by the end of the treatment period, and afobazole was well-tolerated with no major side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychopharmacotherapy of anxiety disorders in patients with cardio-vascular diseases: the use of aphobazole]. Medvedev, VE., Trosnova, AP., Dobrovol'skiĭ, AV.[2016]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Treating acute stress disorder: an evaluation of cognitive behavior therapy and supportive counseling techniques. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Rapid response to acute stress reaction: Pilot test of iCOVER training for military units. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Preparing Soldiers to Manage Acute Stress in Combat: Acceptability, Knowledge and Attitudes. [2022]

4. Croatia pubmed.ncbi.nlm.nih.gov

[Therapeutic possibilities after traumatic experiences]. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Development of an Animal Model of Military-Relevant Traumatic Stress. [2023]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Psychopharmacotherapy of anxiety disorders in patients with cardio-vascular diseases: the use of aphobazole]. [2016]