Promoting Improved Functioning Among People Experiencing Stressful Situations

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06482567
Status
Recruiting
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Conditions

  • Acute Stress Reaction

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Study Details

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).

Key Dates

Start date
Aug 15, 2024
Status verified
Dec 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: iCOVER
    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.
  • Active Comparator: Physical Presence with Reassurance
    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.
  • No Intervention: Usual Care
    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.

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
McLean Hospital, Harvard Medical SchoolBelmontMassachusetts02478-
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655
Abigail Lopes, B.S.
[email protected]
508-421-1226
John Haran, MD, PhD
[email protected]
John Haran, MD, PhD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Brandon Page, B.S.
[email protected]
586-453-2072
Lewandowski, MD
[email protected]
Christopher Lewandowski, MD (PRINCIPAL_INVESTIGATOR)
Washington University, St. LouisSt LouisMissouri63110
Jamie Mills, BS, CCRC
[email protected]
314-273-1382
Stacey House, MD, PhD
[email protected]
Stacey House, MD, PhD (PRINCIPAL_INVESTIGATOR)
Cooper University Health CareCamdenNew Jersey08103
Lauren Remboski, M.S.
[email protected]
856-571-5344
Christopher W Jones, MD
[email protected]
Christopher W Jones, MD (PRINCIPAL_INVESTIGATOR)

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