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

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ClinicalTrials.gov Identifier: NCT02655354
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : May 20, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington

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: Setraline Drug: Citalopram Drug: Venlafaxine Drug: Duloxetine Drug: Mirtazapine Drug: Diphenhydramine Drug: Trazodone Drug: Prazosin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2019

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: 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.



Primary Outcome Measures :
  1. Change from Baseline PTSD Checklist Civilian Over the Course of a Year [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
  2. 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 ]
  3. Change from Baseline Alcohol Use Disorders Identification Over the Course of a Year [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
  4. 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 :
  1. Patient Health Questionnaire Item 9 Suicide Question [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
  2. Trauma Survivors Outcomes and Support (TSOS) Drug Use Items [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
  3. Cognitive Impairment Scale [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
  4. Brief Pain Inventory [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
  5. SF-36 Quality of Life [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
  6. TSOS Patient Satisfaction Questions [ Time Frame: Baseline, 3-month, 6-month, 12-month ]


Information from the National Library of Medicine

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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

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


Contacts
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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
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Principal Investigator: Douglas Zatzick, MD University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 )
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Disease
Wounds and Injuries
Brain Injuries
Cognitive Dysfunction
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
Cognition Disorders
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