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Clinical Trials/NCT03711266
NCT03711266
Completed
N/A

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

University of Michigan2 sites in 1 country35 target enrollmentNovember 1, 2018
ConditionsPTSD

Overview

Phase
N/A
Intervention
Not specified
Conditions
PTSD
Sponsor
University of Michigan
Enrollment
35
Locations
2
Primary Endpoint
Change in PTSD Symptoms (as Measured by the PCL-5)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
September 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca Sripada

Assistant Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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).

Secondary Outcomes

  • 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)

Study Sites (2)

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