Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury (TSOS II)
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|ClinicalTrials.gov Identifier: NCT00270959|
Recruitment Status : Completed
First Posted : December 29, 2005
Last Update Posted : November 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Behavioral: Cognitive Behavioral Therapy Behavioral: Motivational Interviewing Drug: FDA-Approved Anti-Anxiety Medications Behavioral: Standard Care Control||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Combined Intervention After Traumatic Injury|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||March 2013|
Stepped collaborative care (combination of behavioral therapy and drug therapy)
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.
Other Name: CBT
Behavioral: Motivational Interviewing
Motivational interviewing is designed to address alcohol and drug use.
Other Name: MI
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.
Active Comparator: 2
Standard care provided to injured trauma survivors
Behavioral: Standard Care Control
Standard care control includes the usual treatment for injured trauma survivors.
Other Name: BA
- PTSD ratings [ Time Frame: Measured at Year 1 ]
- Substance use [ Time Frame: Measured at Year 1 ]
- General functioning reports [ Time Frame: Measured at Year 1 ]
- Increased satisfaction with global care [ Time Frame: Measured at Year 1 ]
- Injury relapse [ Time Frame: Measured at Year 5 ]
- Work, disability, and legal outcomes [ Time Frame: Measured at Year 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270959
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Douglas F. Zatzick, MD||University of Washington|