Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury
NCT ID: NCT00270959
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
207 participants
INTERVENTIONAL
2006-06-30
2013-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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1
Stepped collaborative care (combination of behavioral therapy and drug therapy)
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.
Motivational Interviewing
Motivational interviewing is designed to address alcohol and drug use.
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.
2
Standard care provided to injured trauma survivors
Standard Care Control
Standard care control includes the usual treatment for injured trauma survivors.
Interventions
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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.
Motivational Interviewing
Motivational interviewing is designed to address alcohol and drug use.
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.
Standard Care Control
Standard care control includes the usual treatment for injured trauma survivors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Washington
OTHER
Responsible Party
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Douglas Zatzick
Professor
Principal Investigators
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Douglas F. Zatzick, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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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. doi: 10.1001/archpsyc.61.5.498.
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. doi: 10.1017/S0033291707000943. 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. doi: 10.1016/j.biopsych.2004.10.005.
Zatzick D, Jurkovich G, Rivara FP, Russo J, Wagner A, Wang J, Dunn C, Lord SP, Petrie M, O'connor SS, Katon W. A randomized stepped care intervention trial targeting posttraumatic stress disorder for surgically hospitalized injury survivors. Ann Surg. 2013 Mar;257(3):390-9. doi: 10.1097/SLA.0b013e31826bc313.
Related Links
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Our study is no longer recruiting, if you are seeking care for PSTD from Harborview Medical Center please follow the link above.
Other Identifiers
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DSIR 82-SECE
Identifier Type: -
Identifier Source: secondary_id
24069
Identifier Type: -
Identifier Source: org_study_id