Intervention for PTSD and Comorbidities in Trauma Survivors
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
NA · University of Washington · NCT05632770
This study tests a new support program for trauma survivors with PTSD and physical injuries to see if it can help them feel better and reduce their visits to the emergency room.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05632770 on ClinicalTrials.gov |
What this trial studies
This investigation is a randomized pragmatic trial that evaluates a brief stepped care intervention for patients with PTSD and physical injuries treated in an acute care medical trauma center. The study aims to reduce PTSD symptoms and decrease emergency department utilization among trauma survivors. It will involve 424 patients who will be randomly assigned to either the intervention group receiving stepped care or a control group receiving standard screening and referral. The trial is designed to enhance mental health support for diverse injury survivors and inform trauma care policies.
Who should consider this trial
Good fit: Ideal candidates are injured patients aged 18 and older who meet specific PTSD risk criteria and speak English or Spanish.
Not a fit: Patients who are under 18, have acute psychiatric conditions, or do not reside in the specified states may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health outcomes for trauma survivors and reduce reliance on emergency services.
How similar studies have performed: Other studies have shown success with similar stepped care approaches for PTSD, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Injured patients ≥18 years of age * Meet ≥ 3 of 10 risk domain criteria in electronic health records (EHR) screen * Score of ≥ 30 on DSM-5 PTSD Checklist (PCL) score or score of ≥ 35 on DSM-IV PTSD Checklist (PCL) . * Speak English and/or Spanish Exclusion Criteria: * Age \<18 * Not admitted for a traumatic injury * Speak a language other than English and/or Spanish * Acutely suicidal/admitted for a suicide attempt * Cognitively impaired * Incarcerated * Acutely psychotic * Not a resident of Washington, California, Alaska, Oregon, Idaho, Montana, or Nevada * Less than 2 pieces of contact information * Prior history of violence, such that study staff may not be safe * Patient with overwhelming psychiatric distress and not advisable/will not tolerate randomization to control condition * Most recent COVID-19 test positive
Where this trial is running
Seattle, Washington
- Harborview Medical Center — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Douglas Zatzick, MD — University of Washington
- Study coordinator: Douglas Zatzick, MD
- Email: dzatzick@uw.edu
- Phone: 206-744-6701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PTSD, Physical Injury, Emergency Department Utilization