Improving PTSD treatment outcomes using adaptive therapy approaches
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 430 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 13 sites (Baldwin, Michigan and 12 other locations) |
| Trial ID | NCT05457985 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe cognitive impairment, high suicide risk, or active substance use disorders may not benefit from this study.
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 performed: Other studies have shown promise in using adaptive interventions for PTSD, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Baldwin, Michigan and 12 other locations
- Family Health Care — Baldwin, Michigan, United States (Terminated)
- 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)
- 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)
Study contacts
- Study coordinator: Kayla Longuski, MS
- Email: kaylsmit@umich.edu
- Phone: 734-647-6258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.