RECRUITING

A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems

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

This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.

Official Title

A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems

Quick Facts

Study Start:2023-01-09
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05632770

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Injured patients ≥18 years of age
  2. * Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen
  3. * Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) .
  4. * Speak English and/or Spanish
  1. * Age \<18
  2. * Not admitted for a traumatic injury
  3. * Speak a language other than English and/or Spanish
  4. * Acutely suicidal/admitted for a suicide attempt
  5. * Cognitively impaired
  6. * Incarcerated
  7. * Acutely psychotic
  8. * Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada
  9. * Less than 2 pieces of contact information
  10. * Prior history of violence, such that study staff may not be safe
  11. * Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition
  12. * Most recent COVID-19 test positive

Contacts and Locations

Study Contact

Douglas Zatzick, MD
CONTACT
206-744-6701
dzatzick@uw.edu
Tanya Knutsen, MSW
CONTACT
206-406-1273

Principal Investigator

Douglas Zatzick, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

Harborview Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Douglas Zatzick, MD, PRINCIPAL_INVESTIGATOR, University of Washington

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 Date2023-01-09
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2023-01-09
Study Completion Date2027-10-31

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Physical Injury
  • Emergency Department Utilization

Additional Relevant MeSH Terms

  • PTSD
  • Physical Injury