Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury (TSOS II)

Early Combined Intervention After Traumatic Injury

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Motivational Interviewing; Drug: FDA-Approved Anti-Anxiety Medications; Behavioral: Standard Care Control

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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 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 Names: CBT; Behavioral: Motivational Interviewing; Motivational interviewing is designed to address alcohol and drug use.; Other Names: 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 Names: BA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PTSD ratings	Measured at Year 1
Substance use	Measured at Year 1
General functioning reports	Measured at Year 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Increased satisfaction with global care	Measured at Year 1
Injury relapse	Measured at Year 5
Work, disability, and legal outcomes	Measured at Year 1

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Douglas F. Zatzick, MD, University of Washington

Publications and helpful links

General Publications

• 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. doi: 10.1001/archpsyc.61.5.498.
• 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. doi: 10.1017/S0033291707000943. Epub 2007 Jun 11.
• 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. doi: 10.1016/j.biopsych.2004.10.005.
• Zatzick D, Jurkovich G, Rivara FP, Russo J, Wagner A, Wang J, Dunn C, Lord SP, Petrie M, O'connor SS, Katon W. A randomized stepped care intervention trial targeting posttraumatic stress disorder for surgically hospitalized injury survivors. Ann Surg. 2013 Mar;257(3):390-9. doi: 10.1097/SLA.0b013e31826bc313.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 28, 2005
• First Submitted That Met QC Criteria: December 28, 2005
• First Posted (Estimate): December 29, 2005

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: PTSD
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries
• Other Study ID Numbers: 24069; R01MH073613 (U.S. NIH Grant/Contract); DSIR 82-SECE