Promoting Improved Functioning Among People Experiencing Stressful Situations

NARecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

August 15, 2024

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., I'm right here with you); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

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 return 5 minutes post-intervention to conduct the immediate post-intervention assessment.

Trial Locations (5)

48202

RECRUITING

Henry Ford Health System, Detroit

63110

RECRUITING

Washington University, St. Louis, St Louis

02478

ACTIVE_NOT_RECRUITING

McLean Hospital, Harvard Medical School, Belmont

01655

RECRUITING

University of Massachusetts Chan Medical School, Worcester

08103

RECRUITING

Cooper University Health Care, Camden

All Listed Sponsors
collaborator

U.S. Army Medical Research Acquisition Activity

FED

lead

University of North Carolina, Chapel Hill

OTHER