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

NCT00270959 | Completed Phase 1 DMC

• 3 other identifiers: 24069R01MH073613DSIR 82-SECE
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (3)

• PTSD ratings

  Measured at Year 1

• Substance use

  Measured at Year 1

• General functioning reports

  Measured at Year 1

Secondary Outcomes (3)

• Increased satisfaction with global care

  Measured at Year 1

• Injury relapse

  Measured at Year 5

• Work, disability, and legal outcomes

  Measured at Year 1

Study Arms (2)

1

EXPERIMENTAL

Stepped collaborative care (combination of behavioral therapy and drug therapy)

Behavioral: Cognitive Behavioral Therapy; Behavioral: Motivational Interviewing; Drug: FDA-Approved Anti-Anxiety Medications

2

ACTIVE COMPARATOR

Standard care provided to injured trauma survivors

Behavioral: Standard Care Control

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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.

Also known as: CBT

1

Motivational Interviewing BEHAVIORAL

Motivational interviewing is designed to address alcohol and drug use.

Also known as: MI

1

FDA-Approved Anti-Anxiety Medications DRUG

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.

1

Standard Care Control BEHAVIORAL

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

Also known as: BA

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (4)

• 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.

  PMID: 15123495 BACKGROUND

• 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.

  PMID: 17559704 BACKGROUND

• 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.

  PMID: 15607305 BACKGROUND

• 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.

  PMID: 23222034 DERIVED

Related Links

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

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy; Motivational Interviewing

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Douglas F. Zatzick, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2005
• First Posted: December 29, 2005
• Study Start: June 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2013
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)