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NCT02655354 · ClinicalTrials.gov registry record · NA
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 635
- Enrollment target
NCT02655354: Completed NA study, sponsored by University of Washington.
NCT02655354 is a NA study that has completed, run by University of Washington. The registered enrollment target is 635 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02655354, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 635 participants
- Enrollment target
Study 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.
Primary Outcome
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Interventions
- BEHAVIORAL Motivational Interviewing
- DRUG Fluoxetine
- DRUG Fluvoxamine
- BEHAVIORAL Cognitive Behavioral Therapy Elements
- BEHAVIORAL Care Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 635 participants |
| Start Date | 2015-10 |
| Est. Completion | 2019-11 |
| Phase | NA |
What the finished NCT02655354 record still lists
NCT02655354 is an interventional study that assigns participants to a tested intervention. The registered 635 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Motivational Interviewing is the first listed.
NCT02655354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02655354 about?
NCT02655354 is a clinical study titled "A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity". 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 patien...
What is the current status of trial NCT02655354?
This trial is currently completed. It is a NA study. The enrollment target is 635 participants. The study started on 2015-10. Estimated completion is 2019-11.
What interventions are being tested in trial NCT02655354?
The interventions under investigation include: Motivational Interviewing (BEHAVIORAL), Fluoxetine (DRUG), Fluvoxamine (DRUG), Cognitive Behavioral Therapy Elements (BEHAVIORAL), Care Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT02655354?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02655354's enrollment target sits among peer trials
635 158th of 2000 higher than 1,843 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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