The Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With PTSD
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index.
研究概览
简要总结
This prospective randomized study evaluates the impact of Supportive Employment (SE) compared to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic posttraumatic stress disorder (PTSD).
详细描述
Hypotheses or Key Questions
I. Primary Hypothesis (obtained + maintained employment): Subjects assigned to IPS will have a higher maintained employed rate for the 12-mo observation period than their standard VRP counterparts.
- I.a. First Component Primary Hypothesis (obtained employment): Subjects assigned to IPS will have higher rates of obtained employment for the 12-mo observation period than the VRP subjects.
- I.b. Second Component Primary Hypothesis (maintained employment): Among those subjects employed, those assigned to IPS will have worked more weeks for the 12-mo observation period than the VRP subjects.
II. Secondary Hypothesis: Those subjects who obtain competitive employment will have significantly reduced symptoms of PTSD from baseline to endpoint compared to those subjects who do not obtain competitive employment.
III. Confirmatory and Correlational Hypotheses: Compared to VRP subjects, those subjects assigned to IPS will have:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •diagnosis of PTSD (based on MINI)
- •male or female
- •any race or ethnicity
- •age 19-60
- •currently unemployed
- •interested in competitive employment
- •planning to remain in a 100-mile radius of participating VAMC for the 12- mo duration
排除标准
- •Lifetime history of severe traumatic brain injury that has resulted in severe cognitive disorder
- •diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
- •dementia (a standard exclusion from VRP)
- •immediate need of detoxification from alcohol or drugs (a standard VRP exclusion)
- •pending active legal charges or expected incarceration
结局指标
主要结局
Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index.
时间窗: 12 months
次要结局
- Using an intent-to-treat analysis, the change from baseline to endpoint in PTSD symptoms is compared between groups using the Clinician Administered PTSD Scale (CAPS).(12 months)
研究者
Lori Davis, MD
ACOS Research and Development
Tuscaloosa Research & Education Advancement Corporation