A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
CompletedNot applicableNCT02655354
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Conditions
- Posttraumatic Stress Disorder
- Depression
- Alcohol-Related Disorders
- Suicidal Ideation
- Substance-Related Disorders
- Mild Cognitive Impairment
- Quality of Life
- Pain
- Wounds and Injury
- Brain Injuries
- Chronic Disease
- Interventions
- Behavioral: Motivational Interviewing
- Behavioral: Cognitive Behavioral Therapy Elements
- Behavioral: Care Management
- Drug: Fluoxetine
- Drug: Fluvoxamine
- Drug: Paroxetine
- Drug: Sertraline
- Drug: Citalopram
- Drug: Venlafaxine
- Drug: Duloxetine
- Drug: Mirtazapine
- Drug: Diphenhydramine
- Drug: Trazodone
- Drug: Prazosin
- Sponsor
- University of Washington
- Collaborators
- National Institutes of Health (NIH); National Institute of Mental Health (NIMH); National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Start date
- 2015-10
- Primary completion
- 2019-11
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 24
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient currently admitted to inpatient/emergency department for a traumatic injury Exclusion Criteria: * Non-English speaking * Self-inflicted injury * Actively psychotic * Incarcerated or in custody * Less than 35 on PTSD Checklist * Less than 3 items on PTSD medical record screen * Less than 2 pieces of contact information
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02655354