N/A
N=635
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
Posttraumatic Stress Disorder · Depression · Alcohol-Related Disorders · Suicidal Ideation · Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02655354 ↗Enrolled (actual)
635
Serious AEs
4.4%
Results posted
Jul 2021
Primary outcome: Primary: Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury — -1.65; 0.08; -4.02; -1.44 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motivational Interviewing (Behavioral); Cognitive Behavioral Therapy Elements (Behavioral); Care Management (Behavioral); Fluoxetine (Drug); Fluvoxamine (Drug); Paroxetine (Drug); Sertraline (Drug); Citalopram (Drug); Venlafaxine (Drug); Duloxetine (Drug); Mirtazapine (Drug); Diphenhydramine (Drug); Trazodone (Drug); Prazosin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury |
-1.65; 0.08; -4.02; -1.44; -5.51; -4.25 | — |
| PRIMARY Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury |
-0.79; -0.50; -1.17; -0.90; -1.84; -2.16 | — |
| PRIMARY Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury |
-2.04; -1.90; -1.69; -1.63; -1.81; -1.45 | — |
| PRIMARY Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury |
-16.78; -15.90; -14.17; -13.83; -13.23; -11.68 | — |
| SECONDARY Number of Participants With Suicidal Ideation |
67; 90; 69; 99; 63; 106 | — |
| SECONDARY Number of Participants Endorsing a Single Item That Assesses Opioid Use |
18; 44; 4; 15; 4; 20 | — |
| SECONDARY Cognitive Impairment Scale |
13.5; 13.4; 13.3; 13.2; 13.2; 13.4 | — |
| SECONDARY Brief Pain Inventory |
6.8; 6.7; 4.3; 4.7; 4.1; 4.5 | — |
| SECONDARY SF-36 Quality of Life |
44.3; 45.1; 38.3; 39.1; 38.4; 39.5 | — |
| SECONDARY TSOS Patient Satisfaction: Overall Health Care |
4.4; 4.4; 3.9; 3.8; 4.0; 3.8 | — |
| SECONDARY Number of Participants Endorsing a Single Item That Assesses Stimulant Use |
58; 77; 9; 17; 7; 22 | — |
| SECONDARY Number of Participants Endorsing a Single Item That Assesses Marijuana Use |
125; 177; 60; 72; 60; 82 | — |
| SECONDARY TSOS Patient Satisfaction: Mental Health Care |
4.1; 4.0; 3.6; 3.5; 3.6; 3.4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02655354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.