Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of post-traumatic stress disorder in people who have survived a traumatic injury.

Detailed Description
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Approximately 2.5 million people in the U.S. are hospitalized each year having sustained injuries during a traumatic event. Injured trauma survivors are at high risk for developing post-traumatic stress disorder (PTSD) and other related conditions. In addition, many of these people experience several physical, financial, social, legal, and medical problems over the course of the year following the trauma. Effective interventions to prevent or remedy these issues have yet to be developed for individuals who undergo inpatient surgery following a traumatic injury and who then continue with outpatient treatment and community rehabilitation. This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of PTSD and substance use. The study will also assess the intervention's effectiveness in increasing participants' general functioning and satisfaction with their care post-injury. Participants in this open label study will be randomly assigned to receive either the standard care provided to injured trauma survivors or a combination of behavioral therapy and drug therapy. Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline; paroxetine; buspirone; propranolol; trazodone; and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Behavioral therapy will also be administered on the basis of the participants' individual needs and may continue for up to 12 months. Participants will also take part in motivational interviews, the first of which will be conducted upon study entry in the hospital ward. Subsequent interviews will be conducted over the phone at Months 1, 3, 6, 9, and 12. Participants will be required to report to the study site only for the initial baseline visit. Outcome measures will include PTSD severity ratings, frequency of substance use, and general functioning reports.

Official Title
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Early Combined Intervention After Traumatic Injury

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Motivational Interviewing
* Drug: FDA-Approved Anti-Anxiety Medications
* Behavioral: Standard Care Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking Admitted to Harborview Medical Center with injuries sufficiently severe to require inpatient admission Experienced a traumatic injury Exhibits symptoms of PTSD while in the hospital ward Exclusion Criteria: History of head, spinal, or other injury that may prevent participation in the ward interview Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania Currently incarcerated Likely to face criminal charges Lives more than 50-100 miles from Harborview Medical Center

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stepped collaborative care (combination of behavioral therapy and drug therapy) | Behavioral: Cognitive Behavioral Therapy<br>* Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.<br>* Other names: CBT;Behavioral: Motivational Interviewing<br>* Motivational interviewing is designed to address alcohol and drug use.<br>* Other names: MI;Drug: FDA-Approved Anti-Anxiety Medications<br>* Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.<br>|
| Active Comparator: 2<br>Standard care provided to injured trauma survivors | Behavioral: Standard Care Control<br>* Standard care control includes the usual treatment for injured trauma survivors.<br>* Other names: BA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD ratings |  | Measured at Year 1 | 
| Substance use |  | Measured at Year 1 | 
| General functioning reports |  | Measured at Year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased satisfaction with global care |  | Measured at Year 1 | 
| Injury relapse |  | Measured at Year 5 | 
| Work, disability, and legal outcomes |  | Measured at Year 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD