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Trial record 47 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

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

Tracking Information
First Submitted Date  ICMJE July 27, 2015
First Posted Date  ICMJE January 14, 2016
Last Update Posted Date December 17, 2019
Study Start Date  ICMJE October 2015
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity
Official Title  ICMJE Not Provided
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2019)
635
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2016)
960
Actual Study Completion Date  ICMJE November 2019
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02655354
Other Study ID Numbers  ICMJE 20150987
UH3MH106338 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Douglas Zatzick, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Douglas Zatzick, MD University of Washington
PRS Account University of Washington
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP