Trauma Survivors Outcomes and Support Study IV (TSOS IV)
Integrating Information Technology Advancements Into Early PTSD Interventions
After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.
Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Washington
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Seattle、Washington、美国、98104
- Harborview Medical Center
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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:
- Score ≥3 on PTSD automated screening algorithm
- Score ≥35 on PTSD checklist (PCL-C)
Exclusion Criteria:
- Non-English speaking
- Under 14 years of age
- Patients in need of acute psychiatric intervention (e.g., suicide attempt, psychosis)
- Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Stepped Care Management
All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns.
The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns.
Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
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All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns.
The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns.
Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
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无干预:Usual Care
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
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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 |
|---|---|---|
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受伤后六个月内抑郁症状的变化
大体时间:研究人员在基线、1 个月、3 个月和 6 个月时进行评估。
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研究人员使用患者健康问卷 (PHQ-9) 作为连续测量,评分范围为 1 至 27。
较高的分数代表较差的结果。
没有使用分量表。
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研究人员在基线、1 个月、3 个月和 6 个月时进行评估。
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Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
大体时间:The investigators assessed at baseline, 1-, 3-, and 6-month.
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The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure.
The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome.
No subscales were used.
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The investigators assessed at baseline, 1-, 3-, and 6-month.
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Technology Use
大体时间:Baseline to 6 months
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The investigators used laptop tracking software to determine technology usage.
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Baseline to 6 months
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Feasibility/Acceptability of Intervention
大体时间:Baseline to 6 months
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The investigators used laptop tracking software to assess number of patients using laptops.
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Baseline to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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酒精使用问题
大体时间:研究人员在基线、1 个月、3 个月和 6 个月时进行评估。
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研究人员使用酒精使用障碍识别测试 (AUDIT) 作为连续测量。
10 项量表评分范围为 0-40,较高的值表示较差的结果。
没有使用子量表。
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研究人员在基线、1 个月、3 个月和 6 个月时进行评估。
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Physical Functioning
大体时间:The investigators assessed at baseline, 1-, 3-, and 6-month.
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The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function.
The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
No other subscales will be used.
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The investigators assessed at baseline, 1-, 3-, and 6-month.
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合作者和调查者
合作者
调查人员
- 首席研究员:Douglas Zatzick, M.D.、University of Washington
出版物和有用的链接
一般刊物
- Zatzick D, O'Connor SS, Russo J, Wang J, Bush N, Love J, Peterson R, Ingraham L, Darnell D, Whiteside L, Van Eaton E. Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. J Trauma Stress. 2015 Oct;28(5):391-400. doi: 10.1002/jts.22041.
- Kelly CM, Van Eaton EG, Russo JE, Kelly VC, Jurkovich GJ, Darnell DA, Whiteside LK, Wang J, Parker LE, Payne TH, Mooney SD, Bush N, Zatzick DF. Technology Use, Preferences, and Capacity in Injured Patients at Risk for Posttraumatic Stress Disorder. Psychiatry. 2017 Fall;80(3):279-285. doi: 10.1080/00332747.2016.1271162.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
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