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Completed

NCT Number: NCT00270959

Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CBT

Motivational Interviewing

Behavioral

Motivational interviewing is designed to address alcohol and drug use.

Other names: MI

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.

Standard Care Control

Behavioral

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

Other names: BA

Primary outcomes

  1. PTSD ratings

    Time frame: Measured at Year 1

  2. Substance use

    Time frame: Measured at Year 1

  3. General functioning reports

    Time frame: Measured at Year 1

Secondary outcomes

  1. Increased satisfaction with global care

    Time frame: Measured at Year 1

  2. Injury relapse

    Time frame: Measured at Year 5

  3. Work, disability, and legal outcomes

    Time frame: Measured at Year 1

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Early Combined Intervention After Traumatic Injury

Acronym: TSOS II

Important dates

Study start
2006
Primary completion
2010
Study completion
2013
First posted
Dec 29, 2005
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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