| December 28, 2005 |
| March 23, 2009 |
| June 2006 |
- PTSD ratings [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Substance use [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- General functioning reports [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
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- PTSD ratings
- Substance use
- General functioning reports (measured 1 year post-injury)
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| Complete list of historical versions of study NCT00270959 on ClinicalTrials.gov Archive Site |
- Increased satisfaction with global care [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Injury relapse [ Time Frame: Measured at Year 5 ] [ Designated as safety issue: Yes ]
- Work, disability, and legal outcomes [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
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- Increased satisfaction with global care
- Injury relapse
- Work, disability, and legal outcomes (measured one year post-injury)
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| |
| Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury |
| 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. |
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. |
| Phase I |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
| Post-Traumatic Stress Disorder |
- Behavioral: Cognitive Behavioral Therapy
- Behavioral: Motivational Interviewing
- Drug: FDA-Approved Anti-Anxiety Medications
- Behavioral: Standard Care Control
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- Experimental: Stepped collaborative care (combination of behavioral therapy and drug therapy)
- Active Comparator: Standard care provided to injured trauma survivors
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- 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.
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| |
| Recruiting |
| 300 |
| September 2009 |
| September 2009 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years and older |
| No |
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|
| United States |
|
| |
| NCT00270959 |
| Douglas Zatzick, Associate Professor, University of Washington School of Medicine |
| DSIR 82-SECE |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
Douglas F. Zatzick, MD |
University of Washington |
|
|
| National Institute of Mental Health (NIMH) |
| March 2009 |
