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临床试验/NCT02004743
NCT02004743已完成不适用

Program Development in Guideline Development, Early Recognition and Specialized Treatment of Post Traumatic Stress Disorder (PTSD) at Sunnybrook Health Sciences Center, Canada's Largest Trauma Center

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
2
主要终点
Depressive symptoms

研究概览

简要总结

Sunnybrook Health Sciences Centre is Canada's largest trauma centre, treating 1,100 patients annually. A traumatic experience can lead to post-traumatic stress disorder, which increases hospital stays, emergency visits and disability. Despite developing leadership to manage a "Code Orange" mass trauma, Sunnybrook lacks guidelines in the psychological management of patients who have experienced trauma. The department of psychiatry currently holds a Traumatic Brain Injury clinic and PTSD services for youth but lacks both immediate intervention, prevention and adult services. This research will enable us to gain best evidence expertise to develop guidelines as well as a sustainable PTSD treatment program, with clear outcomes to assess effectiveness, psychiatric morbidity, use of healthcare, disability and substance abuse.

The five world-expert-consensus intervention resilience based principles will be operationalized in guidelines for the management of trauma patients, their caregivers and in routine nursing and trauma team care from the Emergency to the ward, and discharge, through to outpatient care. It is hypothesized that this will improve the psychological recovery of patients at risk of developing PTSD after a traumatic injury. In addition, early screening and intervention for increased risk of PTSD will be implemented one month after the trauma. It is hypothesized that such trauma informed psychological management, early screening and expert treatment using prolonged exposure will reduce hospital stays, functional disability, as well as longer-term psychiatric morbidity, including substance abuse.

详细描述

The study is a longitudinal interventional study, with a control group who have treatment for their trauma with no guidelines for psychological management, staff training, patient and family intervention/education. In the intervention group, who will have all of the above, participants will be stratified according to risk factors for PTSD and randomized 1:1 in "low risk" and "at risk" groups-those who will have a prolonged exposure intervention and those who will not.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • undergone severe physical trauma within the last 3 days
  • An abbreviated Injury Severity score of 1-3

排除标准

  • 14 years of age or younger
  • an inability to communicate sufficiently in English
  • A diagnosis of psychosis, mental retardation and/or autism

结局指标

主要结局

Depressive symptoms

时间窗: recruitment, 1 month, 3 months & 6 months

The Beck Depression Inventory - Second Edition (BDI-II) will be used at recruitment, 1 month, 3 months, and 6 months follow-up to measure the presence and/or change in depressive symptoms of the patient.

Presence & severity of PTSD symptoms

时间窗: 1 month, 3 months & 6 months

The aim of the study is to observe whether there's a presence and severity (if applicable) of Posttraumatic symptoms in patients who've received the intervention, compared to those who have not. Presence and severity of PTSD symptoms will be measured by: * follow-up at 1 month, 3 months \& 6 months which involve specific PTSD self-report symptom measures: PTSD Symptom Scale * Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorder (SCID) Semi-structured interview performed at 6 months either over the phone or in person

次要结局

  • Self-esteem(recruitment, 1 month, 3 months & 6 months)
  • Anxiety & dissociation symptoms(recruitment & 1 month)
  • Change in patient health & well-being(6 months)
  • Presence & severity of trauma related thoughts and beliefs(1 month, 3 months & 6 months)
  • Change in substance use(recruitment, 1 month, 3 months & 6 months)
  • Locus of Control(recruitment, 1 month, 3 months & 6 months)
  • Self-efficacy(recruitment, 1 month, 3 months & 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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