Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 23
- 主要终点
- Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
研究概览
简要总结
This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs).
The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Are employees at an orginization served by a participating EAP
- •Have a Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score ≥33
- •Have had psychotropic medication stability for at least 4 weeks
- •Inclusion criteria for the qualitative portion of the study:
- •- Enrolled into the randomized clinical trial and were a treatment responder or were a treatment non-responder
排除标准
- •Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
- •High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form: found in protocol)
- •Need for detoxification
- •Active psychosis or unmanaged bipolar disorder, as measured by items 12 and 13 of the cross cutting assessment
- •Currently engagement in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy).
- •Patients who do not speak English will be excluded for logistical reasons.
研究组 & 干预措施
Prolonged Exposure for Primary Care
干预措施: Prolonged Exposure for Primary Care (PE-PC) (Behavioral)
EAP Treatment as Usual (TAU)
Employee Assistance Programs standard treatment.
干预措施: EAP Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) score
时间窗: baseline to 6 months
The PCL-5 is a 20-item self-report measure that assesses symptoms of PTSD. The self-report rating scale is 0-4 for each symptom. The minimum and maximum values are 0 and 80, with higher scores indicating worse outcome.
次要结局
- Change in Patient Satisfaction based on the Client Satisfaction Questionnaire (CSQ-8)(baseline to 6 months)
- Change in Job Performance based on the Work Productivity and Activity Impairment Questionnaire (WPAI-GH)(baseline to 6 months)
- Change in Depressive Symptoms based on the Patient Health Questionnaire (PHQ-9)(baseline to 6 months)
- Change in Burnout based on the Oldenburg Burnout Inventory(baseline to 6 months)
研究者
Rebecca Sripada
Associate Professor of Psychiatry
University of Michigan