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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00270959

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Early Combined Intervention After Traumatic Injury

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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. Behavioral: 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.
2: Active Comparator Standard care provided to injured trauma survivors	Behavioral: Standard Care Control Standard care control includes the usual treatment for injured trauma survivors.

Arms

Assigned Interventions

1: Experimental

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.

Behavioral: 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.

2: Active Comparator

Standard care provided to injured trauma survivors

Behavioral: Standard Care Control

Standard care control includes the usual treatment for injured trauma survivors.

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

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

Contacts

Contact: Grin Geiss Trusz, BA	206-744-9447	strusz@u.washington.edu
Contact: Douglas F. Zatzick, MD	206-744-6701	dzatzick@u.washington.edu

Locations

United States, Washington
Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: Douglas F. Zatzick, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Douglas F. Zatzick, MD

University of Washington

More Information

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.

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.

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.

Responsible Party:	University of Washington School of Medicine ( Douglas Zatzick, Associate Professor )
Study ID Numbers:	R01 MH073613, DSIR 82-SECE
Study First Received:	December 28, 2005
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00270959 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

PTSD

Study placed in the following topic categories:

Fluoxetine
Buspirone
Propranolol
Anxiety Disorders
Mental Disorders
Trazodone

Sertraline
Stress Disorders, Post-Traumatic
Stress
Paroxetine
Stress Disorders, Traumatic
Ethanol

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders

Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on September 10, 2009