Michigan Mental Health Integration Partnership (MIP) - Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
Phase: NA
Conditions: PTSD
Sponsor: University of Michigan

Michigan Mental Health Integration Partnership - Implementing PTSD Treatment in Federally 
Qualified Health Centers for Michigan Medicaid Enrollees 
PE-PC Pilot 
National Clinical Trial Number: NCT03711266
Date:  September 23, 2021
Principal Investigator: 
Rebecca Sripada, PhD, Assistant Professor, University of Michigan Department of Psychiatry 
Supported by: 
Michigan Mental Health Integration Partnership (MIP) Scholars program 
Michigan Department of Health and Human Services 

PROTOCOL SUMMARY 
 
Title:   
 
PE-PC Pilot 
 
Study Description:  
A study 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, 
delivered via telehealth to patients in Community Health Centers (CHCs) in Michigan. 
 
Outcomes:  
Primary Outcome: PE-PC participants will experience reductions in PTSD symptoms as 
measured by the PTSD Checklist for DSM-5 (PCL-5) at 2 months and 4 months. 
 
 
Secondary Outcomes: PE-PC participants will experience reductions in depression as 
measured by the PHQ-9 at 2 months and 4 months. We will also examine the mechanisms 
of PE-PC’s effect by measuring the two potential mediators of intervention effectiveness, 
recovery goals (Recovery Assessment Scale; RAS) and posttraumatic cognitions (Post-
Traumatic Cognitions Inventory; PTCI).  
 
Intervention  
Information:   
Deliver PE-PC to patients via telehealth. This treatment consists of four 30-minute sessions 
of in-vivo and narrative exposure, with content drawn from the PE model.1 
 
Study Population:  
The sample will consist of 50 participants, age 18 and older, of any gender, race or 
ethnicity, who are currently enrolled at a CHC and screen positive for PTSD on the PCL-5 
(PCL-5 ≥ 33).  
Locations:  
 
University of Michigan 
 
 
 
Family Medical Center of Michigan 
Hamilton Community Health Network 
Family Health Care 
 
Estimated Study  
 
Start Date:  
 
October 1, 2018  
 
Study Duration:  
2 years 
 
 
 
 

1  
BACKGROUND & RATIONALE  
 
1.1  
Background 
 
Posttraumatic stress disorder (PTSD) is a disorder that develops following exposure to traumatic events such as 
rape, assault, natural disaster, or combat. It is associated with distress, impairment, and greater risk for adverse 
health outcomes, including among Michigan Medicaid enrollees.2 The percentage of patients screening positive for 
PTSD in primary care settings has been estimated to range from 14%-23%.3-6  
 
Despite this high prevalence, treatment for PTSD is severely limited at CHCs.7 In addition, patients with PTSD may 
be reluctant to seek care in specialty mental health clinics.8 Furthermore, community mental health providers 
rarely have training in efficacious PTSD treatments, and community dissemination and implementation efforts have 
had mixed success.9 Thus, there is significant need for a brief PTSD treatment delivered in the primary care setting. 
Providing brief PTSD treatment in the primary care setting aligns with the MDHHS Section 298 Initiative to 
coordinate physical health services and behavioral health services. 
 
1.2  
Study Rationale 
 
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. 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 half 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.1 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.10 These 
changes were maintained at 6-month follow-up. 
 
2  
OUTCOMES  
 
2.1  
Primary Outcome  
 
The Primary Outcome measure is change in PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5). 
PCL-5 will be administered at baseline, 2-months post-enrollment (around the time of treatment completion) and 
4-months post- enrollment. Two 2-month and 4-month surveys will be administered regardless of whether the 
patient has completed the intervention. 
 

1. PCL-5 [Time Frame: Baseline, 2-months, 4-months] 
The PCL-511 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”). 
The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant 
validity.12,13 Scores ≥ 33 indicate a probable diagnosis of PTSD. 
 
2.2  
Secondary Outcomes  
 
1. Depressive symptoms (measured by the Patient Health Questionnaire; PHQ-9)14,15 [Time Frame: Baseline, 2-
months, 4-months] 
2. Recovery goals (measured by the Recovery Assessment Scale; RAS)16,17 [Time Frame: Baseline, 2-months, 4-
months]  
3. Posttraumatic cognitions (measured by the Post-Traumatic Cognitions Inventory; PTCI)18 
[Time Frame: Baseline, 2-months, 4-months]  
 
3  
STUDY DESIGN 
 
The goal of this pilot project is to deliver PE-PC to 50 patients via telehealth and evaluate patients’ engagement 
with the treatment, satisfaction, and PTSD-related outcomes. This is an open trial. All participants will receive the 
same intervention. 
 
4  
SELECTION AND ENROLLMENT OF PARTICIPANTS 
 
The population of interest is individuals with PTSD who receive services from CHCs in Michigan. 
 
4.1  
Inclusion Criteria 
The goal of the study inclusion and exclusion criteria is to identify a broadly representative sample of CHC patients 
with PTSD.  
 
Patients will be eligible for the study if they: 
1) are age 18 years or older 
2) receive care at a Michigan CHC 
3) have a PCL-5 score ≥33 
4) have had psychotropic medication stability for at least 4 weeks 
 
4.2  
Exclusion Criteria 
Patients will be excluded if they are: 1) substantially cognitively impaired, 2) unable to agree to study procedures 
for any reason (including incompetency), 3) at high risk of suicide, or 4) currently engaged 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. 
 
4.3  
Recruitment 
Participants will be recruited from the following CHCs: Family Medical Center of Michigan, Hamilton 
Community Health Network, and Family Health Care. All three clinics are all currently engaged in University of 
Michigan research studies and strongly endorse the current study. 
 
 
5  
STUDY INTERVENTIONS 
 

5.1  
Delivery and Duration  
 
PE-PC will be delivered by the telepsychologist via interactive video technology, or telehealth.  
 
5.2  
Interventionist Training 
 
Therapist training and PE-PC implementation PE-PC will be guided by Dr. Sheila Rauch and Dr. Jeffrey Cigrang, 
treatment developers of PE-PC. Dr. Rauch and Dr. Cigrang have established a PE-PC training protocol that includes 
didactic training followed by phone consultation on training cases. Trainers will augment this training with case 
review to establish competence.  
 
5.3 
Delivery of Treatment 
 
Eligible participants are individuals presenting in CHCs who screen positive for PTSD, using validated screening 
measures currently used in multiple Michigan CHCs. Those who screen positive will be connected by a warm 
handoff to the research assistant (or will call us after being provided with our contact information), who will 
review inclusion/exclusion criteria, present the study information sheet, and schedule the first meeting with the 
telepsychologist. 
 
PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn 
from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 
30-minute appointments scheduled approximately once a week over 4-6 weeks (to accommodate scheduling and 
missed appointments). Before beginning the 4-session treatment, the telepsychologist will schedule an initial 
appointment with the patient to determine the index trauma and answer any questions about the treatment. 
During the first PE-PC session, the PC-MHI provider will review the “Confronting Uncomfortable Memories” 
activity workbook to be completed at home and brought back for use in subsequent sessions. The workbook asks 
the patient to write a detailed first-person narrative of the event associated with the greatest level of current 
distress, including recollection of personal thoughts, feelings, and physical reactions. Emotional processing 
questions are also included. In addition, the telepsychologist will plan for in-vivo exposure activities between 
sessions. The patient will be instructed to complete the memory exposure for 30 minutes each day between 
sessions. At the second PE-PC session, the telepsychologist will review the patient’s exposures, problem-solve any 
implementation difficulties, and process the exercises. The patient will then read the narrative and his or her 
answers to the emotional processing questions out loud and they will process the exercise. Practice continues 
between sessions. This session format and content are repeated at the third and fourth sessions. At the end of the 
fourth session, the telepsychologist and patient will review treatment progress assisted by results of the PTSD 
Checklist for DSM-5 (PCL-5) administered during the fourth session. Participants who still need or desire treatment 
at the conclusion of PE-PC will receive referrals to other mental health resources.   
 
6  
STATISTICAL ANALYSIS 
 
We used paired t-tests and multiple regression to determine symptom change over time. Multiple 
imputation was used to impute missing data. Ten imputed datasets were generated, and coefficients and 
standard errors were adjusted for the variability between imputations according to Rubin’s combination rule.19 
We included auxiliary variables that were correlated with the missing variables at r > 0.4.20 Imputation procedures 
were conducted in SAS, using the Markov Chain Monte Carlo approach. 
 
 

 
7  
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