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

Phase 1

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Standard Care Control; Behavioral: Motivational Interviewing; Drug: FDA-Approved Anti-Anxiety Medications

• Registration Number: NCT00270959
• Lead Sponsor: University of Washington

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.

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.

Study Timeline

• Study First Submitted: 2005-12-28
• Study First Submitted QC: 2005-12-28
• Study First Posted: 2005-12-29
• Study Start: 2006-06
• Primary Completion: 2010-09
• Study Completion: 2013-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Cognitive Behavioral Therapy	Stepped collaborative care (combination of behavioral therapy and drug therapy)
2	Standard Care Control	Standard care provided to injured trauma survivors
1	Motivational Interviewing	Stepped collaborative care (combination of behavioral therapy and drug therapy)
1	FDA-Approved Anti-Anxiety Medications	Stepped collaborative care (combination of behavioral therapy and drug therapy)

Primary Outcome Measures

Name	Time	Method
Substance use	Measured at Year 1
General functioning reports	Measured at Year 1
PTSD ratings	Measured at Year 1

Secondary Outcome Measures

Name	Time	Method
Increased satisfaction with global care	Measured at Year 1
Injury relapse	Measured at Year 5
Work, disability, and legal outcomes	Measured at Year 1

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States