iCOVER for Acute Stress Disorder

(iCOVER Trial)

Recruiting at 5 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?

This trial tests a quick intervention called iCOVER, designed to rapidly alleviate Acute Stress Reactions (ASR). The goal is to evaluate iCOVER's effectiveness compared to usual care or simple reassurance. iCOVER consists of six steps to help individuals feel connected and re-engaged, and it can be completed in just a few minutes. Individuals in the emergency room who are visibly upset and can speak English may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance emergency care for many.

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.

What prior data suggests that the iCOVER intervention is safe for individuals experiencing an Acute Stress Reaction?

Research has shown that the iCOVER method is designed to help people quickly recover from an Acute Stress Reaction (ASR). Various settings, including the military, have used this treatment to help individuals regain focus and function properly. Although detailed safety information is not fully available, past studies indicate that iCOVER is well-received by those trained to use it, such as soldiers.

The iCOVER method involves simple steps to help a person return to the present moment and engage in purposeful activity. These steps take only 60-120 seconds, making the process quick and straightforward, which likely reduces any risk for participants. Its widespread use suggests confidence in its safety and effectiveness. However, since the trial is in the "Not Applicable" phase, more detailed safety data from controlled studies may still be needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about iCOVER for Acute Stress Disorder because it offers a fresh approach compared to standard treatments, like cognitive-behavioral therapy or medication, which can take weeks to show benefits. iCOVER is unique because it involves a quick, targeted intervention lasting just 60–120 seconds, providing immediate support to individuals. This new technique focuses on rapid intervention, potentially reducing the immediate effects of stress before they escalate, which could revolutionize how acute stress is managed.

What evidence suggests that this trial's treatments could be effective for Acute Stress Disorder?

Research has shown that the iCOVER program was created to help people quickly recover from Acute Stress Reactions (ASR). In this trial, participants in the iCOVER arm will receive this intervention, designed to be easy and fast, aiding a swift return to normal life. Similar programs, such as those involving peer support, have demonstrated good results in managing stress. The iCOVER approach includes steps like connecting with the person, checking facts, and encouraging action, which help individuals focus on the present and engage in meaningful activities. Although solid data on iCOVER's effectiveness is not yet available, its structured method is based on ideas that have shown promise in similar situations. ^{1 2 3 6 7}

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

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]

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]

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11409414/

A novel intervention for acute stress reaction This study assesses the feasibility of ReSTART training, a peer-based course designed to prepare soldiers to manage ASRs.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06482567

Study Details | NCT06482567 | Promoting Improved ... The iCOVER intervention was developed to rapidly restore functioning in individuals experiencing an Acute Stress Reaction (ASR). iCOVER is undergoing ...

3. protocolesixc.org protocolesixc.org/wp-content/uploads/2024/01/Svetlitzky-et-al.-2019_YaHaLOM-A-Rapid-Intervention-for-Acute-Stress-Reactions-in-High-Risk-Occupations.pdf

YaHaLOM: A Rapid Intervention for Acute Stress Reactions ... Following an overview of diagnostic and clinical considerations, we review the potential frameworks for developing YaHaLOM, detail the five steps of the ...

4. militaryhealth.bmj.com militaryhealth.bmj.com/content/jramc/early/2023/06/05/military-2022-002344.full.pdf

Peer-based intervention for acute stress reaction 18 A follow- on study examined iCOVER training with units weeks before they deployed to combat; results demonstrated high training accept-.

5. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-acute-6-2024-68997

iCOVER for Acute Stress Disorder (iCOVER Trial) 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 ...

6. militaryhealth.bmj.com militaryhealth.bmj.com/content/170/5/425

Peer-based intervention for acute stress reaction 18 A follow-on study examined iCOVER training with units weeks before they deployed to combat; results demonstrated high training acceptability, improvements in ...

7. ovid.com ovid.com/journals/pttrpp/pdf/10.1037/tra0000487~rapid-response-to-acute-stress-reaction-pilot-test-of-icover

Pilot Test of iCOVER Training for Military Units Teams performing under dangerous conditions may find a team member suddenly has an acute stress reaction, potentially jeopardizing the lives of that individual ...