Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers

Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers

This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working.

The central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Clinician Supported PTSD Coach App; Behavioral: Full Prolonged Exposure; Behavioral: Prolonged Exposure for Primary Care (PE-PC)

• Study Type: Interventional
• Enrollment (Estimated): 430
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Walters; Phone Number: 734-845-3650; Email: heawalte@umich.edu
• Study Contact Backup: Name: Kayla Longuski, MS; Phone Number: 734-647-6258; Email: kaylsmit@umich.edu

Study Locations

• United States
  • Michigan
    • Baldwin, Michigan, United States, 49304
      • Terminated
      • Family Health Care
    • Battle Creek, Michigan, United States, 49037
      • Recruiting
      • Grace Health
      • Contact: Eric Macleod
      • Principal Investigator: Eric Macleod
    • Flint, Michigan, United States, 48503
      • Recruiting
      • Hamilton Community Health Network
      • Contact: Albert Ujkaj
      • Principal Investigator: Albert Ujkaj
    • Flint, Michigan, United States, 48503
      • Recruiting
      • Genesee Community Health Center
      • Contact: Brian Nicholson
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Cherry Health
      • Contact: Lindsey Metts
      • Principal Investigator: Eric Achtyes
    • Houghton Lake, Michigan, United States, 48629
      • Recruiting
      • MidMichigan Community Health Services
      • Contact: Stacey Gedeon
      • Principal Investigator: Stacey Gedeon
    • Menominee, Michigan, United States, 49858
      • Recruiting
      • Upper Great Lakes Family Health Care Center
      • Contact: Savanna Weber
      • Principal Investigator: Donald Simila
    • Monroe, Michigan, United States, 48162
      • Recruiting
      • Family Medical Center of Michigan
      • Contact: Erica Keith
      • Principal Investigator: Erica Keith
    • Sterling, Michigan, United States, 48659
      • Recruiting
      • Sterling Area Health Center
      • Contact: Linda LaTulip
      • Principal Investigator: Linda LaTulip
  • Missouri
    • Saint Louis, Missouri, United States, 63111
      • Recruiting
      • Family Care Health Centers
      • Contact: Jordanna Riebel
      • Principal Investigator: Jordanna Riebel
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Recruiting
      • Western North Carolina Community Health Services
      • Contact: Jessica Parsil
      • Principal Investigator: Jessica Parsil
  • Texas
    • Austin, Texas, United States, 78702
      • Recruiting
      • CommUnityCare Health Centers
      • Contact: Heather Gause
      • Principal Investigator: Heather Gause
  • Washington
    • Bellingham, Washington, United States, 98225
      • Recruiting
      • Unity Care NW
      • Contact: Beth Williams
      • Principal Investigator: Beth Williams

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Receive care at a participating federally qualified health center (FQHC)
• Have a Posttraumatic Stress Disorder checklist (PCL-5) score greater or equal (≥) to 33
• Own a mobile device that can be used for the PTSD Coach App
• Have had psychotropic medication stability for at least 4 weeks

Exclusion Criteria:

• Severe cognitive impairment that in the judgment of the investigators makes it unlikely that the participant can adhere to the study regimen (as evidenced by confusion, inability to track discussion or answer questions, or other clear and significant indicators of cognitive impairment)
• High risk of suicide (defined as meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form
• Severe alcohol or substance use disorder (moderate-severe alcohol use disorder on Alcohol Use Disorders Identification Test (AUDIT) (scores ≥ 15) or high risk on National Institute on Drug Abuse Quick Screen (scores ≥ 27))
• Active psychosis or unmanaged bipolar disorder
• Unstable housing
• Current engagement 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged Exposure for Primary Care (PE-PC) then continue as early responder; PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage (for 8 weeks).	Behavioral: Prolonged Exposure for Primary Care (PE-PC); Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.
Experimental: Clinician Supported PTSD Coach App then full PE; During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.	Behavioral: Clinician Supported PTSD Coach App; This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user.; Behavioral: Full Prolonged Exposure; Treatment will follow the standardized PE manual. Participants will have 60 minute sessions once a week for eight weeks During these sessions, participants will practice in vivo, imaginal, and emotional exposure as well as continue these exposure exercises every day at home.
Experimental: Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC; PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to continue with PE-PC (medium intensity) will continue weekly sessions for 8 weeks.	Behavioral: Prolonged Exposure for Primary Care (PE-PC); Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.
Experimental: Clinician Supported PTSD Coach App then continued CS PTSD Coach App; During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to continue this treatment will have the frequency reduced to twice monthly.	Behavioral: Clinician Supported PTSD Coach App; This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user.
Experimental: Clinician Supported (CS) PTSD Coach App then continue as early responder; During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first). Early responders will be encouraged to continue app use but will discontinue clinician support sessions for the remaining 8 weeks.	Behavioral: Clinician Supported PTSD Coach App; This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user.
Experimental: Prolonged Exposure for Primary Care (PE-PC) then full PE; PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to full PE and will have sessions once a week for eight weeks. During these 60-minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.	Behavioral: Full Prolonged Exposure; Treatment will follow the standardized PE manual. Participants will have 60 minute sessions once a week for eight weeks During these sessions, participants will practice in vivo, imaginal, and emotional exposure as well as continue these exposure exercises every day at home.; Behavioral: Prolonged Exposure for Primary Care (PE-PC); Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)	The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.	Baseline, 3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PTSD symptoms by the PTSD Checklist (PCL-5)	The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity).	Baseline, 3-months
Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)	There are 9 questions that reflects the overall functioning and impairment due to the depressive symptoms. Scores ranges from 0 to 27, with a higher score indicating more severe symptoms.	Baseline, 3-months
Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)	The EQ-5D-5L assesses patients' overall quality of life and health. This measure asks questions related to mobility, self-care, activity, pain, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The participant indicates his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension. The measure also includes one 0-100 scale assessing how patients perceive their overall health.	Baseline, 3-months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 10, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: PTSD symptoms; Mobile device; Prolonged Exposure for Primary Care; Clinician Supported PTSD Coach App; Prolonged Exposure/PE
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HUM00203165; 1R01MH125857-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No