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Clinical trialNCT02655354CompletedInterventional

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

SponsorUniversity of WashingtonEnrollment635Alcohol-Related DisordersBrain InjuriesChronic DiseaseDepressionMild Cognitive ImpairmentPain+5 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and related comorbidity. Each year in the United States (US), over 30 million individuals present to trauma centers, emergency departments, and other acute care medical settings for the treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management treatment models for PTSD and related comorbidities exist. These care management models have the potential to be flexibly implemented in order to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries; care management models may also be effective in mitigating the impact of the acute injury event on symptom exacerbations in the large subpopulation of injury survivors who already carry a substantial pre-injury burden of multiple chronic medical conditions.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

24 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Honor Health

    Scottsdale, Arizona, United States

  • Cedars Sinai

    Beverly Hills, California, United States

  • U.C. Davis

    Sacramento, California, United States

  • Santa Clara Valley Medical Center

    San Jose, California, United States

  • U.C.L.A. Harbor

    Torrance, California, United States

  • Hartford Hospital

    Hartford, Connecticut, United States

  • Georgia Regents

    Augusta, Georgia, United States

  • Eskenazi Health

    Indianapolis, Indiana, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • University of Kentucky

    Lexington, Kentucky, United States

  • Louisiana State University

    New Orleans, Louisiana, United States

  • Regions Hospital

    Saint Paul, Minnesota, United States

  • University of Rochester

    Rochester, New York, United States

  • Jacobi Medical Center

    The Bronx, New York, United States

  • Wake Forest

    Winston-Salem, North Carolina, United States

  • University of Cincinnati

    Cincinnati, Ohio, United States

  • Ohio State University

    Columbus, Ohio, United States

  • Baylor Health Care System

    Dallas, Texas, United States

  • Ut Southwestern Medical Center

    Dallas, Texas, United States

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, United States

  • the University of Utah

    Salt Lake City, Utah, United States

  • the University of Vermont

    Burlington, Vermont, United States

  • Inova Trauma Center

    Falls Church, Virginia, United States

  • the University of Wisconsin Madison

    Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2015
Primary completion
30 Nov 2019
Completion
30 Nov 2019
Last update posted
2 Jul 2021
Registered enrollment
635
Registry id
NCT02655354

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.