A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
研究概览
简要总结
The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatient/Emergency Admission for traumatic injury
排除标准
- •Non-English speaking
- •Self-inflicted injury
- •Actively psychotic
- •Incarcerated or in custody
研究组 & 干预措施
Intervention
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
干预措施: Motivational Interviewing (Behavioral)
Intervention
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
干预措施: Cognitive Behavioral Therapy Elements (Behavioral)
Intervention
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
干预措施: Psychotropic Drugs (Drug)
Intervention
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
干预措施: Care Management (Other)
结局指标
主要结局
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
时间窗: Baseline and 1-month
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month
时间窗: Baseline and 1-month
The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.
Change From Baseline Alcohol Use Disorders Identification at 1 Month
时间窗: Baseline and 1-month
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
次要结局
- Change in Functional Status(Baseline and 1-month)
- Patient Health Questionnaire Item 9 Suicide Question(Baseline and 1-month)
- Number of Participants Endorsing a Single Item That Assesses Drug Use(Baseline and 1-month)
- Cognitive Impairment Scale(Baseline and 1-month)
研究者
Douglas Zatzick
Professor, Psychiatry & Behavioral Sciences
University of Washington