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Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees (PE-PC Pilot)

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ClinicalTrials.gov Identifier: NCT03711266
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Michigan Department of Health and Human Services
Information provided by (Responsible Party):
Rebecca Sripada, University of Michigan

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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: PE-PC Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Michigan Mental Health Integration Partnership (MIP) - Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid

Arm Intervention/treatment
Experimental: PE-PC
Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry.
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




Primary Outcome Measures :
  1. Change in PTSD symptoms (as measured by the PCL-5) [ Time Frame: Baseline, 4-months ]
    The PCL-516 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.17,18 Scores ≥ 33 indicate a probable diagnosis of PTSD.


Secondary Outcome Measures :
  1. Change in depressive symptoms (as measured by the PHQ-9) [ Time Frame: Baseline, 4-months ]
    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). 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.

  2. Change in Recovery goals (measured by the Recovery Assessment Scale; RAS) [ Time Frame: Baseline, 4-months ]
    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. The RAS-SF shows evidence for both convergent and discriminant validity when compared to quality of life, social support, and symptomatic scales.

  3. Change in Posttraumatic cognitions (measured by the Post-Traumatic Cognitions Inventory; PTCI) [ Time Frame: Baseline, 4-months ]
    The PTCI is a 33-item scale, which is rated on a Likert-type scale ranging from 1 (totally disagree) to 7 (totally agree). Total score is the sum of items 1-33. The inventory also yields three subscales - negative cognitions about the self, negative cognitions about the world, and self-blame. To allow for the different numbers of statements making up each subscale, the scores are calculated by taking the total for the subscale and dividing it by the number of statements involved - giving an average score per statement for each subscale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711266


Contacts
Contact: Rebecca Sripada, PhD 734-222-7432 rekaufma@med.umich.edu
Contact: Heather Walters, MS 734-845-3650 heawalte@med.umich.edu

Locations
United States, Michigan
Baldwin Family Health Care-Cadillac Clinic Recruiting
Cadillac, Michigan, United States, 49349
Contact: Heather Walters, MS    734-845-3650    heawalte@med.umich.edu   
Contact: Rebecca Sripada, PhD    734-222-7432    rekaufma@med.umich.edu   
Hamilton Community Health Network-Flint Clinic Recruiting
Flint, Michigan, United States, 48503
Contact: Heather Walters, MS    734-845-3650    heawalte@med.umich.edu   
Contact: Rebecca Sripada, PhD    734-222-7432    rekaufma@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Michigan Department of Health and Human Services
Investigators
Principal Investigator: Rebecca Sripada, PhD University of Michigan

Responsible Party: Rebecca Sripada, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03711266     History of Changes
Other Study ID Numbers: HUM00149877
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No