RECRUITING

Promoting Improved Functioning Among People Experiencing Stressful Situations

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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them back to the present moment; (3) Offer commitment so that the individual feels less psychologically isolated and withdrawn (e.g., "I'm right here with you"); (4) Verify facts - ask simple fact-based questions to engage the individual in deliberate cognitive activity; (5) Establish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

Official Title

Promoting Improved Functioning Among People Experiencing Stressful Situations

Quick Facts

Study Start:2024-08-15
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06482567

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years and ≤ 50 years of age (if age not known, appears to be)
  2. * In the emergency department as a patient or loved one of a patient
  3. * If a patient, anticipated to be discharged to home from the emergency department after evaluation
  4. * Exhibiting visible signs of distress Richmond Agitation and Sedation Scale ((RASS) (+1 to +3)) or dissociation (awake and alert but reduced responsiveness)
  5. * Likely able to speak English
  1. * Known pregnancy
  2. * Prisoner or in custody
  3. * Known history of psychosis or bipolar disorder
  4. * Known or suspected drug intoxication
  5. * Known history of substantial cognitive impairment
  6. * Known or suspected altered mental status due to traumatic brain injury
  7. * Known active psychosis, suicidal ideation, or homicidal ideation
  8. * Unable to use both hands (e.g. due to sprain)
  9. * 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)

Contacts and Locations

Study Contact

Jenni Shafer, PhD
CONTACT
919-360-0681
jenni_shafer@med.unc.edu
Allison Britt, BS
CONTACT
919-605-1046
allison_britt@med.unc.edu

Principal Investigator

Samuel McLean, MD, MPH
PRINCIPAL_INVESTIGATOR
University of North Carollina at Chapel Hill

Study Locations (Sites)

McLean Hospital, Harvard Medical School
Belmont, Massachusetts, 02478
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Washington University, St. Louis
Saint Louis, Missouri, 63110
United States
Cooper University Health Care
Camden, New Jersey, 08103
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Samuel McLean, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carollina at Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Trauma
  • Acute Stress Disorder
  • Acute Stress Reaction
  • Post Traumatic Stress
  • Post Traumatic Stress Disorder
  • Substantial Distress
  • Dissociation
  • Distress
  • Neurocognitive function

Additional Relevant MeSH Terms

  • Acute Stress Reaction