短暂延长暴露疗法与临床标准疗法在减轻脊髓损伤后创伤后应激障碍方面的比较
预防创伤后应激障碍：脊髓损伤（SCI）住院康复期间改良简短延长暴露疗法（Brief PE）的随机对照试验
This study will examine the use brief prolonged exposure (Brief PE) therapy compared to standard clinical care to reduce posttraumatic distress among people who have had a spinal cord injury and are receiving rehabilitation in an inpatient setting.
研究概览
详细说明
This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered in an inpatient rehabilitation setting post-SCI to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after SCI and to mitigate long-term post-SCI distress including PTSD as well as secondary health outcomes (including depression and general anxiety) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Dallas、Texas、美国、75204
- Kirstie A Jones
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years of age or older
- Admitted to the inpatient rehabilitation hospital diagnosed with a SCI following a traumatic event
Exclusion Criteria:
- Patients in police custody
- Not fluent in the English language
- Severe cognitive impairment
- Patients who are acutely suicidal
- Patients with active psychosis
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Treatment as Usual
Participants in the Treatment as Usual (TAU) group will not receive Prolonged Exposure therapy, but will instead receive the standard clinical treatment received by all persons with spinal cord injury (SCI) at the rehabilitation facility. TAU participants will complete questionnaires/interviews at 1, 3, and 6 months from Baseline. |
This may include an evaluation by a licensed psychologist and continued follow-up psychotherapy as needed. Treatment as usual participants will have follow-up assessments at 1, 3, and 6 months. |
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实验性的：Brief Prolonged Exposure
Experimental: Brief Prolonged Exposure Participants will receive Brief PE. Subjects in the Brief Prolonged Exposure (BPE) intervention group will additionally receive 3 total therapy sessions, each lasting about 60 minutes spaced about 1-7 days apart. Sessions include education about common reactions to trauma, breathing retraining, identification of self-care tasks and prolonged (repeated) imaginal exposure to trauma memories. Any missed sessions will be made up by scheduling multiple sessions in subsequent weeks. Individuals in the BPE group will complete a screener and then survey questionnaires/ interviews at 1, 3, and 6 months from Baseline. |
Brief PE will include 3 therapy sessions, each lasting approximately 60 minutes. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in PSSI-5: PTSD Symptom Scale - Interview for DSM-5
大体时间：Baseline, 1 month, 3 months ,6 months
|
Change in PTSD symptoms from baseline to 6 months. Total scale ranges from 0-80 points. Higher score indicates greater severity of symptoms. |
Baseline, 1 month, 3 months ,6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Patient Health Questionnaire-9
大体时间：Baseline, 1 month, 3 months ,6 months
|
Change in depressed mood from baseline to 6 months. Scored on a 0-27 scale. Higher score indicates greater severity of issues. |
Baseline, 1 month, 3 months ,6 months
|
|
Change in Generalized Anxiety Disorder-7 Item
大体时间：Time Frame: Baseline, 1 month, 3 months, 6 months
|
Change in anxiety scored using a 0-21 scale. Higher score indicates greater anxiety. |
Time Frame: Baseline, 1 month, 3 months, 6 months
|
合作者和调查者
调查人员
- 首席研究员：Ann Maria Warren, PhD、Baylor Scott and White Research Institute-Trauma
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.