Official Title: “Early Combined Intervention After Traumatic Injury”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2009

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.

Intervention(s) in this Clinical Trial

• Behavioral: Cognitive Behavioral Therapy
  • 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.
• Behavioral: Motivational Interviewing
  • Motivational interviewing is designed to address alcohol and drug use.
• Drug: FDA-Approved Anti-Anxiety Medications
  • 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.
• Behavioral: Standard Care Control
  • Standard care control includes the usual treatment for injured trauma survivors.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Stepped collaborative care (combination of behavioral therapy and drug therapy)
• Active Comparator: 2
  • Standard care provided to injured trauma survivors

Primary Measures

• PTSD ratings
  • Time Frame: Measured at Year 1
    Safety Issue?: No
• Substance use
  • Time Frame: Measured at Year 1
    Safety Issue?: No
• General functioning reports
  • Time Frame: Measured at Year 1
    Safety Issue?: No

Secondary Measures

• Increased satisfaction with global care
  • Time Frame: Measured at Year 1
    Safety Issue?: No
• Injury relapse
  • Time Frame: Measured at Year 5
    Safety Issue?: Yes
• Work, disability, and legal outcomes
  • Time Frame: Measured at Year 1
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Douglas F. Zatzick, MD Principal Investigator University of Washington  

Overall Contact: Kimberly McCoy, MA 206-744-1757 mccoyk2@u.washington.edu

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00270959

Study ID Number: R01 MH73613

ClinicalTrials.gov Identifier: NCT00270959

Health Authority: United States: Federal Government