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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00270959 |
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.
Condition | Intervention | Phase |
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Post-Traumatic Stress Disorder |
Behavioral: Cognitive Behavioral Therapy Behavioral: Motivational Interviewing Drug: FDA-Approved Anti-Anxiety Medications Behavioral: Standard Care Control |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | Early Combined Intervention After Traumatic Injury |
Estimated Enrollment: | 300 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Stepped collaborative care (combination of behavioral therapy and drug therapy)
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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.
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2: Active Comparator
Standard care provided to injured trauma survivors
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Behavioral: Standard Care Control
Standard care control includes the usual treatment for injured trauma survivors.
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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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kimberly McCoy, MA | 206-744-1757 | mccoyk2@u.washington.edu |
Contact: Douglas F. Zatzick, MD | 206-731-6701 | dzatzick@u.washington.edu |
United States, Washington | |
Harborview Medical Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Principal Investigator: Douglas F. Zatzick, MD |
Principal Investigator: | Douglas F. Zatzick, MD | University of Washington |
Responsible Party: | University of Washington School of Medicine ( Douglas Zatzick, Associate Professor ) |
Study ID Numbers: | R01 MH73613, DSIR 82-SECE |
Study First Received: | December 28, 2005 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00270959 |
Health Authority: | United States: Federal Government |
PTSD |
Fluoxetine Buspirone Propranolol Anxiety Disorders Mental Disorders Trazodone |
Sertraline Stress Disorders, Post-Traumatic Stress Paroxetine Stress Disorders, Traumatic Ethanol |
Pathologic Processes Disease |