Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury

Post-Traumatic Stress Disorder Clinical Trial

— TSOS II  

Official title:

Early Combined Intervention After Traumatic Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270959
• Other study ID #: 24069
• Secondary ID: R01MH073613DSIR
• Status: Completed
• Phase: Phase 1
• Start date: June 2006
• Est. completion date: March 2013

Study information

• Verified date: November 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: March 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries

Intervention

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.
• 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.

Behavioral:
• Standard Care Control
Standard care control includes the usual treatment for injured trauma survivors.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Epub 2007 Jun 11. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD ratings		Measured at Year 1
Primary	Substance use		Measured at Year 1
Primary	General functioning reports		Measured at Year 1
Secondary	Increased satisfaction with global care		Measured at Year 1
Secondary	Injury relapse		Measured at Year 5
Secondary	Work, disability, and legal outcomes		Measured at Year 1

External Links

•   Our study is no longer recruiting, if you are seeking care for PSTD from Harborview Medical Center please follow the link above.