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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
Results First Posted : July 2, 2021
Last Update Posted : July 2, 2021
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
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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
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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
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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
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Primary Outcome Measures :
  1. Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.

  2. Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.

  3. Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.

  4. Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.


Secondary Outcome Measures :
  1. Number of Participants With Suicidal Ideation [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.

  2. Number of Participants Endorsing a Single Item That Assesses Opioid Use [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.

  3. Cognitive Impairment Scale [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.

  4. Brief Pain Inventory [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.

  5. SF-36 Quality of Life [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.

  6. TSOS Patient Satisfaction: Overall Health Care [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.

  7. Number of Participants Endorsing a Single Item That Assesses Stimulant Use [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.

  8. Number of Participants Endorsing a Single Item That Assesses Marijuana Use [ Time Frame: Baseline, 3-month, 6-month, 12-month ]
    Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.

  9. TSOS Patient Satisfaction: Mental Health Care [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.


Eligibility Criteria
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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
Contacts and Locations
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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
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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
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Principal Investigator: Douglas Zatzick, MD University of Washington
  Study Documents (Full-Text)

Documents provided by Douglas Zatzick, University of Washington:
Study Protocol and Statistical Analysis Plan  [PDF] October 17, 2018

More Information
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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    
Other Study ID Numbers: 20150987
UH3MH106338 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2016    Key Record Dates
Results First Posted: July 2, 2021
Last Update Posted: July 2, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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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