A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity (TSOS6)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02655354

Recruitment Status : Completed

First Posted : January 14, 2016

Last Update Posted : December 17, 2019

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Institute of Mental Health (NIMH)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Douglas Zatzick, University of Washington

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
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	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	Not Applicable

Detailed Description:

Primary Aims and Hypotheses

The primary aim of the UH3 period is to conduct a pragmatic randomized effectiveness trial of a collaborative care intervention targeting PTSD and comorbid conditions after acute care injury hospitalization. The investigation aims to determine if injured patients receiving the collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared to control patients receiving care as usual. The study also aims to determine if the intervention patients when compared to control patients will demonstrate significant reductions in depressive symptoms, suicidal ideation, and alcohol use problems, and improvements in physical function. The primary hypothesis is that the intervention group when compared to the control group will demonstrate significant reductions in PTSD symptoms over the course of the year after injury. Secondary hypotheses are that intervention patients when compared to control patients will demonstrate, significant reductions in depressive symptoms, significant reductions in alcohol use problems, and improved post-injury physical function.

A Priori Secondary Analyses

The study team hypothesizes that a subgroup of patients will have persistent PTSD symptoms that will not remit over the longitudinal course of the investigation, regardless of randomization to intervention or control group conditions. The study team also anticipates that readily identifiable baseline clinical, injury and demographic characteristics will be associated with persistent PTSD symptoms over time (e.g., higher PTSD symptom levels, greater pre-injury trauma exposure, intentional injury including firearm related injury mechanisms and other characteristics such as unemployment, as well as other baseline factors). Derived from previous randomized clinical trials, a cumulative burden index has been developed from these baseline characteristics and will be adapted for the current investigation. The study team proposes a series of secondary analyses that adjust for and stratify by baseline characteristics that put patients at risk for persistent symptoms. It is hypothesized that these secondary analyses will identify a subgroup of intervention patients who are not at risk for persistent symptoms and who will demonstrate clinically and statistically significant treatment responses when compared to patients with similar baseline characteristics in the control condition. The study team also hypothesizes that the treatment effects will be greatest at the 1-6 month post-injury time points that are temporally correlated with the period of active intervention.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	635 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Study Start Date :	October 2015
Actual Primary Completion Date :	November 2019
Actual Study Completion Date :	November 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.	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
No Intervention: Usual Care Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.

Arm

Intervention/treatment

Experimental: Intervention

The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.

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

No Intervention: Usual Care

Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.

Outcome Measures

Primary Outcome Measures :

Change from Baseline PTSD Checklist Civilian Over the Course of a Year [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
Change from Baseline Patient Health Questionnaire 9 item Depression Scale Over the Course of a Year [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
Change from Baseline Alcohol Use Disorders Identification Over the Course of a Year [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
Change from Baseline Short Form (SF)-12/36 Physical Function Over the Course of a Year [ Time Frame: Baseline, 3-month, 6-month, 12-month ]

Secondary Outcome Measures :

Patient Health Questionnaire Item 9 Suicide Question [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
Trauma Survivors Outcomes and Support (TSOS) Drug Use Items [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
Cognitive Impairment Scale [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
Brief Pain Inventory [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
SF-36 Quality of Life [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
TSOS Patient Satisfaction Questions [ Time Frame: Baseline, 3-month, 6-month, 12-month ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655354

Locations

Show 24 study locations

Layout table for location information

United States, Arizona
Honor Health
Scottsdale, Arizona, United States, 85251
United States, California
Cedars Sinai
Beverly Hills, California, United States, 90211
U.C. Davis
Sacramento, California, United States, 95816
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
U.C.L.A. Harbor
Torrance, California, United States, 90509
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Georgia
Georgia Regents
Augusta, Georgia, United States, 30912
United States, Indiana
Eskenazi Health
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Louisiana State University
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
Baylor Health Care System
Dallas, Texas, United States, 75204
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
United States, Utah
The University of Utah
Salt Lake City, Utah, United States, 84132
United States, Vermont
The University of Vermont
Burlington, Vermont, United States, 05405
United States, Virginia
Inova Trauma Center
Falls Church, Virginia, United States, 22042
United States, Wisconsin
The University of Wisconsin Madison
Madison, Wisconsin, United States, 53715

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

National Institute of Mental Health (NIMH)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Layout table for investigator information

Principal Investigator:	Douglas Zatzick, MD	University of Washington

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zatzick DF, Russo J, Darnell D, Chambers DA, Palinkas L, Van Eaton E, Wang J, Ingraham LM, Guiney R, Heagerty P, Comstock B, Whiteside LK, Jurkovich G. An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity. Implement Sci. 2016 Apr 30;11:58. doi: 10.1186/s13012-016-0424-4.

Layout table for additonal information

Responsible Party:	Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier:	NCT02655354
Other Study ID Numbers:	20150987 UH3MH106338 ( U.S. NIH Grant/Contract )
First Posted:	January 14, 2016 Key Record Dates
Last Update Posted:	December 17, 2019
Last Verified:	December 2019

Additional relevant MeSH terms:

Layout table for MeSH terms

Brain Injuries Disease Chronic Disease Substance-Related Disorders Alcohol-Related Disorders Wounds and Injuries Cognitive Dysfunction Stress Disorders, Post-Traumatic Suicidal Ideation Pathologic Processes Behavioral Symptoms Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma	Trauma, Nervous System Cognition Disorders Neurocognitive Disorders Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders Disease Attributes Suicide Self-Injurious Behavior Chemically-Induced Disorders Diphenhydramine Promethazine Prazosin Duloxetine Hydrochloride Mirtazapine

To Top