Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees

PTSD Clinical Trial

— PE-PC Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711266
• Other study ID #: HUM00149877
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• PE-PC
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

Locations

Country	Name	City	State
United States	Baldwin Family Health Care-Cadillac Clinic	Cadillac	Michigan
United States	Hamilton Community Health Network-Flint Clinic	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Michigan Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Symptoms (as Measured by the PCL-5)	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).	Baseline, 4-months
Secondary	Change in Depressive Symptoms (as Measured by the PHQ-9)	The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day) with a range of scores between 0-27. Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Data presented represent a change from baseline PHQ-9 assessment to the 4-month PHQ-9 assessment (e.g., value at baseline minus value at 4 months).	Baseline, 4-months
Secondary	Change in Recovery Goals (Measured by the Recovery Assessment Scale; RAS)	Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. All items on the RAS assessment are rated on a 5-point Likert scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Not Sure, 4 = Agree, and 5 = Strongly Agree with a range of scores between 20-100. All items are summed to compute a total score. Higher scores indicate greater recovery orientation. The RAS-SF shows evidence for both convergent and discriminant validity when compared to quality of life, social support, and symptomatic scales. Data presented represent a change from baseline RAS-SF assessment to the 4-month RAS-SF assessment (e.g., value at baseline minus value at 4 months)).	Baseline, 4-months
Secondary	Change in Posttraumatic Cognitions (Measured by the Post-Traumatic Cognitions Inventory; PTCI)	The PTCI is a 33-item scale of trauma-related thoughts and beliefs which is rated on a Likert-type scale ranging from 1 (totally disagree) to 7 (totally agree). It is composed of 3 subscales. Each subscale is calculated by averaging the items in the subscale. The PTCI total score is calculated as the sum of the three subscales and ranges from 3 to 21. Results reported here are total scores, not subscale scores. Higher scores represent more dysfunctional cognitions. Data presented represent a change from baseline PTCI assessment to the 4-month PTCI assessment (e.g., value at baseline minus value at 4 months).	Baseline, 4-months