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临床试验/NCT00270959
NCT00270959已完成1 期

Early Combined Intervention After Traumatic Injury

University of Washington1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
207
试验地点
1
主要终点
Substance use

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

1

Experimental

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

干预措施: Cognitive Behavioral Therapy (Behavioral)

1

Experimental

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

干预措施: Motivational Interviewing (Behavioral)

1

Experimental

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

干预措施: FDA-Approved Anti-Anxiety Medications (Drug)

2

Active Comparator

Standard care provided to injured trauma survivors

干预措施: Standard Care Control (Behavioral)

结局指标

主要结局

Substance use

时间窗: Measured at Year 1

General functioning reports

时间窗: Measured at Year 1

PTSD ratings

时间窗: Measured at Year 1

次要结局

  • Increased satisfaction with global care(Measured at Year 1)
  • Injury relapse(Measured at Year 5)
  • Work, disability, and legal outcomes(Measured at Year 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Zatzick

Professor

University of Washington

研究点 (1)

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