Clinical trial NCT03711266: Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
Official title: Michigan Mental Health Integration Partnership (MIP) - Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
First posted: 2018-10-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in PTSD Symptoms (as Measured by the PCL-5)
timeFrame: Baseline, 4-months
Secondary outcomes:
measure: Change in Depressive Symptoms (as Measured by the PHQ-9)
timeFrame: Baseline, 4-months
measure: Change in Recovery Goals (Measured by the Recovery Assessment Scale; RAS)
timeFrame: Baseline, 4-months
measure: Change in Posttraumatic Cognitions (Measured by the Post-Traumatic Cognitions Inventory; PTCI)
timeFrame: Baseline, 4-months
Other outcomes:
Locations:
city: Cadillac
country: United States
facility: Baldwin Family Health Care-Cadillac Clinic
state: Michigan
city: Flint
country: United States
facility: Hamilton Community Health Network-Flint Clinic
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rebecca Sripada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sripada RK, Walters HM, Ganoczy D, Avallone KM, Cigrang JA, Rauch SAM. Feasibility and Acceptability of Prolonged Exposure in Primary Care (PE-PC) for Posttraumatic Stress Disorder in Federally Qualified Health Centers: A Pilot Study. Adm Policy Ment Health. 2022 Sep;49(5):722-734. doi: 10.1007/s10488-022-01195-1. Epub 2022 Apr 20.