跳至主要内容
临床试验/NCT03711266
NCT03711266已完成不适用

Michigan Mental Health Integration Partnership (MIP) - Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees

University of Michigan4 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
4
主要终点
Change in PTSD Symptoms (as Measured by the PCL-5)

研究概览

简要总结

The purpose of this project is to expand access to trauma-focused treatment among Medicaid Enrollees with PTSD, thereby improving the quality of mental health services delivered to this population. Specifically, the project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan.

详细描述

This project directly addresses the Michigan Department of Health and Human Services (MDHHS) Mental Health and Wellness commission priority to provide "better access to high quality, coordinated and consistent service and care between agencies, service providers and across geographical boundaries."

The project goals are to evaluate the delivery and sustainability of a brief trauma-focused treatment, Prolonged Exposure for Primary Care (PE-PC), an evidence-based intervention for PTSD, when delivered via telehealth to patients enrolled at CHCs in Michigan. CHCs serve 680,000 Michigan residents across 260 delivery sites. Ninety-two percent of CHC patients have incomes below 200 percent of the federal poverty level. Approximately 16 percent of CHC patients are uninsured, and more than 53 percent rely on Medicaid for their insurance. Thus, providing PTSD treatment to CHC patients will improve care to Medicaid enrollees and promote Mental Health and Wellness commission priorities of developing a trauma informed system that includes implementation of evidence-based trauma-informed care.

To address the high burden of PTSD in Medicaid enrollees in Michigan CHCs, we plan to deliver PE-PC to patients in CHCs. This treatment consists of four 30-minute sessions of in-vivo and narrative exposure, with content drawn from the PE model. Recently published efficacy data from a randomized controlled trial showed that PE-PC significantly reduced PTSD and depression symptoms as compared to usual primary care treatment. These changes were maintained at 6-month follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • receive care at a Michigan CHC
  • have a PCL-5 score ≥33
  • have had psychotropic medication stability for at least 4 weeks

排除标准

  • substantially cognitively impaired (according to the Mini-Cog)
  • unable to agree to study procedures for any reason (including incompetency)
  • at high risk of suicide
  • currently engaged in a trauma-focused behavioral treatment (such as Prolonged Exposure or Cognitive Processing Therapy)
  • unable to speak English

结局指标

主要结局

Change in PTSD Symptoms (as Measured by the PCL-5)

时间窗: Baseline, 4-months

The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores ≥ 33 indicate a probable diagnosis of PTSD. Data presented represent a change from baseline PCL-5 assessment to the 4-month PCL-5 assessment (e.g., value at baseline minus value at 4 months).

次要结局

  • Change in Recovery Goals (Measured by the Recovery Assessment Scale; RAS)(Baseline, 4-months)
  • Change in Depressive Symptoms (as Measured by the PHQ-9)(Baseline, 4-months)
  • Change in Posttraumatic Cognitions (Measured by the Post-Traumatic Cognitions Inventory; PTCI)(Baseline, 4-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Sripada

Assistant Professor

University of Michigan

研究点 (4)

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