Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Traumatic Stress Disorder
Intervention: Cognitive Behavioral Therapy (Behavioral); Motivational Interviewing (Behavioral); FDA-Approved Anti-Anxiety Medications (Drug); Standard Care Control (Behavioral)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of Washington
Official(s) and/or principal investigator(s):
Douglas F. Zatzick, MD, Principal Investigator, Affiliation: University of Washington
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.
Official title: Early Combined Intervention After Traumatic Injury
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
General functioning reports
Increased satisfaction with global care
Work, disability, and legal outcomes
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
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Admitted to Harborview Medical Center with injuries sufficiently severe to require
- Experienced a traumatic injury
- Exhibits symptoms of PTSD while in the hospital ward
- History of head, spinal, or other injury that may prevent participation in the ward
- 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
Locations and Contacts
Harborview Medical Center, Seattle, Washington 98104, United States
Our study is no longer recruiting, if you are seeking care for PSTD from Harborview Medical Center please follow the link above.
Zatzick D, Roy-Byrne P, Russo J, Rivara F, Droesch R, Wagner A, Dunn C, Jurkovich G, Uehara E, Katon W. A randomized effectiveness trial of stepped collaborative care for acutely injured trauma survivors. Arch Gen Psychiatry. 2004 May;61(5):498-506.
Zatzick DF, Rivara FP, Nathens AB, Jurkovich GJ, Wang J, Fan MY, Russo J, Salkever DS, Mackenzie EJ. A nationwide US study of post-traumatic stress after hospitalization for physical injury. Psychol Med. 2007 Oct;37(10):1469-80. Epub 2007 Jun 11.
Zatzick DF, Russo J, Pitman RK, Rivara F, Jurkovich G, Roy-Byrne P. Reevaluating the association between emergency department heart rate and the development of posttraumatic stress disorder: A public health approach. Biol Psychiatry. 2005 Jan 1;57(1):91-5.
Starting date: June 2006
Last updated: June 19, 2012