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

This study is currently recruiting participants.

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Contacts and Locations

Verified May 2016 by Douglas Zatzick, University of Washington

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Douglas Zatzick, University of Washington

ClinicalTrials.gov Identifier:

NCT02655354

First received: July 27, 2015

Last updated: May 18, 2016

Last verified: May 2016

History of Changes

Purpose

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	Intervention
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: Setraline Drug: Citalopram Drug: Venlafaxine Drug: Duloxetine Drug: Mirtazapine Drug: Diphenhydramine Drug: Trazodone Drug: Prazosin


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment

Further study details as provided by Douglas Zatzick, University of Washington:

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 ]


Estimated Enrollment:	960
Study Start Date:	October 2015
Estimated Study Completion Date:	June 2019
Estimated Primary Completion Date:	September 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: Setraline 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.

Arms

Assigned Interventions

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: Setraline

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02655354

Contacts


Contact: Doyanne Darnell, PhD	206-744-9108	tsoshelp@uw.edu

Show 24 Study Locations

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

Investigators


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.


Responsible Party:	Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier:	NCT02655354 History of Changes
Other Study ID Numbers:	UH3MH106338-02 ( U.S. NIH Grant/Contract )
Study First Received:	July 27, 2015
Last Updated:	May 18, 2016

Additional relevant MeSH terms:


Disease Wounds and Injuries Brain Injuries Cognition Disorders Mild Cognitive Impairment Stress Disorders, Post-Traumatic Chronic Disease Substance-Related Disorders Suicidal Ideation Alcohol-Related Disorders Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma	Trauma, Nervous System Neurocognitive Disorders Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders Disease Attributes Chemically-Induced Disorders Suicide Self-Injurious Behavior Behavioral Symptoms Duloxetine Hydrochloride Venlafaxine Hydrochloride Fluoxetine Paroxetine Citalopram

ClinicalTrials.gov processed this record on July 17, 2017

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