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 (PTSD) in people who have survived a traumatic injury.

Condition	Intervention	Phase
Post-Traumatic Stress Disorder	Behavior: Cognitive Behavioral Therapy  Behavior: Motivational Interviewing  Drug: FDA-Approved Anti-Anxiety Medications	Phase I

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcomes: PTSD ratings; Substance use; General functioning reports (measured 1 year post-injury)
Secondary Outcomes: Increased satisfaction with global care; Injury relapse; Work, disability, and legal outcomes (measured one year post-injury)
Expected Total Enrollment:  300

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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
• Meets diagnostic criteria for PTSD one month post-injury

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
• Screens positive for cocaine or amphetamine use at the time of hospital admission
• History of severe violence
• Likely to face criminal charges
• Lives more than 100 miles from Harborview Medical Center

Please refer to this study by ClinicalTrials.gov identifier  NCT00270959

Angela R. Ghesquiere, MSW      206-744-1757    arg6@u.washington.edu
Douglas F. Zatzick, MD      206-731-6701    dzatzick@u.washington.edu

Washington
      Harborview Medical Center, Seattle,  Washington,  98104,  United States

Study chairs or principal investigators

Douglas F. Zatzick, MD,  Principal Investigator,  University of Washington   

Study ID Numbers:  R01 MH73613; DSIR 82-SECE
Last Updated:  December 28, 2005
Record first received:  December 28, 2005
ClinicalTrials.gov Identifier:  NCT00270959
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10