Clinical trial Recruiting at 12 sites Interventional Ages 18 and up

Improving PTSD treatment outcomes using adaptive therapy approaches

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

Run by University of Michigan · NCT05457985 · Data updated 2026-11-12

This study tests if using a flexible approach to therapy for PTSD, starting with simpler treatments and adjusting based on how patients respond, can lead to better results.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment430 (estimated)
SponsorUniversity of Michigan
Academic / other
Locations13 sites (Baldwin, Michigan and 12 other locations)
StatusRecruiting
StartedJune 23, 2022
Main results expectedAugust 31, 2027
Study endsSeptember 30, 2027
Registry record updatedJuly 1, 2026
Trial IDNCT05457985 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals receiving care at participating federally qualified health centers who have a PTSD checklist score of 33 or higher and own a mobile device for app use.

Probably not a fit

Patients with severe cognitive impairment, high suicide risk, or active substance use disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to develop a stepped-care model for treating patients with PTSD by comparing the effectiveness of different therapy types. It investigates whether starting with a low- or medium-intensity intervention and adjusting based on patient response leads to better outcomes. The study utilizes prolonged exposure therapy and a mobile app to support treatment. Participants will receive care at federally qualified health centers and will be monitored for symptom reduction over the course of the intervention.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with PTSD.

How similar studies have gone: Other studies have shown promise in using adaptive interventions for PTSD, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Grace Health
    Battle Creek, Michigan, United States
    Recruiting
  • Genesee Community Health Center
    Flint, Michigan, United States
    Recruiting
  • Hamilton Community Health Network
    Flint, Michigan, United States
    Recruiting
  • Cherry Health
    Grand Rapids, Michigan, United States
    Recruiting
  • MidMichigan Community Health Services
    Houghton Lake, Michigan, United States
    Recruiting
  • Upper Great Lakes Family Health Care Center
    Menominee, Michigan, United States
    Recruiting
Show 7 more locations
  • Family Medical Center of Michigan
    Monroe, Michigan, United States
    Recruiting
  • Sterling Area Health Center
    Sterling, Michigan, United States
    Recruiting
  • Family Care Health Centers
    St Louis, Missouri, United States
    Recruiting
  • Western North Carolina Community Health Services
    Asheville, North Carolina, United States
    Recruiting
  • CommUnityCare Health Centers
    Austin, Texas, United States
    Recruiting
  • Unity Care NW
    Bellingham, Washington, United States
    Recruiting
  • Family Health Care
    Baldwin, Michigan, United States
    Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.