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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington
ClinicalTrials.gov Identifier:
NCT00270959
First received: December 28, 2005
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorder
Behavioral: Cognitive Behavioral Therapy
Behavioral: Motivational Interviewing
Drug: FDA-Approved Anti-Anxiety Medications
Behavioral: Standard Care Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Combined Intervention After Traumatic Injury

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: June 2006
Estimated Study Completion Date: December 2015
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270959

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Douglas F. Zatzick, MD University of Washington
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00270959     History of Changes
Other Study ID Numbers: R01 MH073613, R01MH073613, DSIR 82-SECE
Study First Received: December 28, 2005
Last Updated: June 19, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Wounds and Injuries
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014