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

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.

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

Anti-depressant

DRUG

Fluvoxamine

Anti-depressant

DRUG

Paroxetine

Anti-depressant

DRUG

Sertraline

Anti-depressant

DRUG

Citalopram

Anti-depressant

DRUG

Venlafaxine

Anti-depressant

DRUG

Duloxetine

Anti-depressant

DRUG

Mirtazapine

Anti-depressant

DRUG

Diphenhydramine

Sleep medication

DRUG

Trazodone

Sleep medication

DRUG

Prazosin

Sleep medication

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Douglas Zatzick, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2019-11-30

Completion

2019-11-30

Countries

• United States

Study Locations