CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 635 enrolled
Drug / intervention
Fluoxetine +13 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02655354
NCT02655354N/ACompleted

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

University of Washington·interventional·Posted Jan 14, 2016·Updated Jul 2, 2021

In Brief

A clinical study evaluating Motivational Interviewing, Cognitive Behavioral Therapy Elements, and 12 other interventions for Posttraumatic Stress Disorder and 10 related conditions. Completed, enrolled 635 participants across 24 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 14, 2016
Enrollment StartOct 1, 2015
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.5 years ago

Interventions

Motivational Interviewingbehavioral

Cognitive Behavioral Therapy Elementsbehavioral

Care Managementbehavioral

Fluoxetinedrug

Anti-depressant

Fluvoxaminedrug

Anti-depressant

Paroxetinedrug

Anti-depressant

Sertralinedrug

Anti-depressant

Citalopramdrug

Anti-depressant

Venlafaxinedrug

Anti-depressant

Duloxetinedrug

Anti-depressant

Mirtazapinedrug

Anti-depressant

Diphenhydraminedrug

Sleep medication

Trazodonedrug

Sleep medication

Prazosindrug

Sleep medication