Promoting Improved Functioning Among People Experiencing Stressful Situations

Overview

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Interventions

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activi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

Primary outcome measures

• Neurocognitive function at the immediate post-intervention assessment [Time frame: Immediately post-intervention (5 mins)]

Secondary outcome measures (10)

• Test My Brain Digit Symbol Matching [Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention]
• Test My Brain Choice Reaction Time Test [Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention]
• Test My Brain Multiple Object Tracking Test [Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention]
• Test My Brain Gradual Onset Continuous Performance Test [Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention]
• Total time spent attempting the four Test My Brain neurocognitive tests [Time frame: 5 min post-intervention]
• Subjective Distress assessed via the Subjective Units of Distress (SUDS) scale [Time frame: 5 mins, 1 hour, 2 days, 7 days post-intervention]
• Acute Stress Disorder symptoms severity assessed via the Acute Stress Disorder Scale [Time frame: 2 days, 7 days post-intervention]
• Sleep Quality assessed using the Insomnia Severity Index [Time frame: 2 days, 7 days post-intervention]
• Functional Impairment using the PROMIS Global Health Scale v1.2 [Time frame: 2 days, 7 days post-intervention]
• Acute Stress Reaction symptoms using the Stress Monitoring and Response Tool (SMART) [Time frame: 1 hour, 2 days, 7 days post-intervention]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 5 centers

• McLean Hospital, Harvard Medical School — Belmont
• University of Massachusetts Chan Medical School — Worcester
• Henry Ford Health System — Detroit
• Washington University, St. Louis — St Louis
• Cooper University Health Care — Camden

Publications

• Janicki AJ, Frisch SO, Patterson PD, Brown A, Frisch A. Emergency Medicine Residents Experience Acute Stress While Working in the Emergency Department. West J Emerg Med. 2020 Dec 11;22(1):94-100. doi: 10.5811/westjem.2020.10.47641. PMID 33439813
• Hoffmann MC. Assessment of Acute Trauma Exposure Response for FIRE-EMS Personnel. J Appl Meas. 2016;17(4):458-475. PMID 28009592
• Ly V, Roijendijk L, Hazebroek H, Tonnaer C, Hagenaars MA. Incident experience predicts freezing-like responses in firefighters. PLoS One. 2017 Oct 18;12(10):e0186648. doi: 10.1371/journal.pone.0186648. eCollection 2017. PMID 29045469
• Halpern J, Maunder RG, Schwartz B, Gurevich M. The critical incident inventory: characteristics of incidents which affect emergency medical technicians and paramedics. BMC Emerg Med. 2012 Aug 3;12:10. doi: 10.1186/1471-227X-12-10. PMID 22862821
• Marmar CR, Weiss DS, Metzler TJ, Delucchi K. Characteristics of emergency services personnel related to peritraumatic dissociation during critical incident exposure. Am J Psychiatry. 1996 Jul;153(7 Suppl):94-102. doi: 10.1176/ajp.153.7.94. PMID 8659646
• Ringer T, Moller D, Mutsaers A. Distress in Caregivers Accompanying Patients to an Emergency Department: A Scoping Review. J Emerg Med. 2017 Oct;53(4):493-508. doi: 10.1016/j.jemermed.2017.03.028. Epub 2017 May 9. PMID 28499745
• Chang BP, Sumner JA, Haerizadeh M, Carter E, Edmondson D. Perceived clinician-patient communication in the emergency department and subsequent post-traumatic stress symptoms in patients evaluated for acute coronary syndrome. Emerg Med J. 2016 Sep;33(9):626-31. doi: 10.1136/emermed-2015-205473. Epub 2016 Apr 28. PMID 27126406
• Muller HHO, Czwalinna K, Wang R, Lucke C, Lam AP, Philipsen A, Gschossmann JM, Moeller S. Occurence of Post-Traumatic Stress Symptoms, Anxiety and Depression in the Acute Phase of Transient Ischemic Attack and Stroke. Psychiatr Q. 2021 Sep;92(3):905-915. doi: 10.1007/s11126-020-09873-9. Epub 2021 Jan 2. PMID 33387257

Identifiers

NCT: NCT06482567 · 23-2628 · CDMRP-TP220430

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗