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

Recruiting now · Not applicable

Conditions studied: PTSD

In brief

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.

Key facts

Study ID

NCT05457985

Run by

University of Michigan

People needed

430

Starts

2022-06-23

Expected to finish

2027-09-30

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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