A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity (TSOS6)
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|ClinicalTrials.gov Identifier: NCT02655354|
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : December 17, 2019
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||635 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||November 2019|
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
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.
- 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 ]
- 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 ]
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
|Principal Investigator:||Douglas Zatzick, MD||University of Washington|