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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 : November 5, 2019
Sponsor:
Collaborator:
Michigan Department of Health and Human Services
Information provided by (Responsible Party):
Rebecca Sripada, University of Michigan

Tracking Information
First Submitted Date  ICMJE October 12, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03711266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
Official Title  ICMJE Michigan Mental Health Integration Partnership (MIP) - Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: PE-PC
Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry.
Intervention: Behavioral: PE-PC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Sripada, PhD 734-222-7432 rekaufma@med.umich.edu
Contact: Heather Walters, MS 734-845-3650 heawalte@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03711266
Other Study ID Numbers  ICMJE HUM00149877
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rebecca Sripada, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Michigan Department of Health and Human Services
Investigators  ICMJE
Principal Investigator: Rebecca Sripada, PhD University of Michigan
PRS Account University of Michigan
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP