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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

December 28, 2005
June 19, 2012
June 2006
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • PTSD ratings
  • Substance use
  • General functioning reports (measured 1 year post-injury)
Complete list of historical versions of study NCT00270959 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Increased satisfaction with global care
  • Injury relapse
  • Work, disability, and legal outcomes (measured one year post-injury)
Not Provided
Not Provided
 
Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • 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.
  • Behavioral: Standard Care Control
    Standard care control includes the usual treatment for injured trauma survivors.
    Other Name: BA
  • Experimental: 1
    Stepped collaborative care (combination of behavioral therapy and drug therapy)
    Interventions:
    • Behavioral: Cognitive Behavioral Therapy
    • Behavioral: Motivational Interviewing
    • Drug: FDA-Approved Anti-Anxiety Medications
  • Active Comparator: 2
    Standard care provided to injured trauma survivors
    Intervention: Behavioral: Standard Care Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
December 2015
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00270959
R01 MH073613, R01MH073613, DSIR 82-SECE
Yes
Douglas Zatzick, University of Washington
University of Washington
National Institute of Mental Health (NIMH)
Principal Investigator: Douglas F. Zatzick, MD University of Washington
University of Washington
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP