Overview

This trial is active, not recruiting.

Condition post-traumatic stress disorder
Treatments cognitive behavioral therapy, motivational interviewing, fda-approved anti-anxiety medications, standard care control
Phase phase 1
Sponsor University of Washington
Collaborator National Institute of Mental Health (NIMH)
Start date June 2006
End date September 2010
Trial size 300 participants
Trial identifier NCT00270959, DSIR 82-SECE, R01 MH073613, R01MH073613

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Stepped collaborative care (combination of behavioral therapy and drug therapy)
cognitive behavioral therapy CBT
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 MI
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.
(Active Comparator)
Standard care provided to injured trauma survivors
standard care control BA
Standard care control includes the usual treatment for injured trauma survivors.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Early Combined Intervention After Traumatic Injury
Principal investigator Douglas F. Zatzick, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by University of Washington.