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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

NCT05632770 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

  • PTSD
  • Physical Injury

Interventions

BEHAVIORAL

Stepped Collaborative Care

Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.

BEHAVIORAL

American College of Surgeons (ACS) Required Screening and Referral (Usual Care)

The study will contribute to usual care with the study 10-domain electronic health record (EHR) screen and the posttraumatic stress disorder (PTSD) evaluation. The study team may also collaborate with hospital providers on the referral process and/or inform a member of the patient's care team of distress patients are experiencing as identified by a DSM-5 PTSD Checklist (PCL) score of ≥ 30 or a DSM-IV PTSD Checklist (PCL) score of ≥ 35.

Sponsors & Collaborators

Principal Investigators

  • Douglas Zatzick, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2027-07-31
Completion
2027-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05632770 on ClinicalTrials.gov