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| Descriptive Information Fields | |||||||||
| Brief Title † | Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury | ||||||||
| Official Title † | Early Combined Intervention After Traumatic Injury | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | 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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| Secondary Outcome Measure † | 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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| Condition † | Post-Traumatic Stress Disorder | ||||||||
| Intervention † | Behavioral: Cognitive Behavioral Therapy Behavioral: Motivational Interviewing Drug: FDA-Approved Anti-Anxiety Medications Behavioral: Standard Care Control |
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| MEDLINE PMIDs | 15123495, 17559704, 15607305 | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 300 | ||||||||
| Start Date † | June 2006 | ||||||||
| Completion Date | September 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00270959 | ||||||||
| Organization ID | R01 MH73613 | ||||||||
| Secondary IDs †† | DSIR 82-SECE | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2008 | ||||||||
| First Received Date † | December 28, 2005 | ||||||||
| Last Updated Date | April 14, 2008 | ||||||||
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