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

NCT05457985 · University of Michigan
In plain English

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Official title
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
About this study
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.
Eligibility 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.
Study design
Enrollment target: 430 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2022-06-23
Estimated completion: 2026-05
Last updated: 2025-08-14
Interventions
Behavioral: Prolonged Exposure for Primary Care (PE-PC)Behavioral: Full Prolonged ExposureBehavioral: Clinician Supported PTSD Coach App
Primary outcomes
  • Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) (Baseline, 3-months)
Sponsor
University of Michigan · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactKayla Longuski, MS · contact · kaylsmit@umich.edu · 734-647-6258
ContactHeather Walters · contact · heawalte@umich.edu · 734-845-3650
All locations (13)
Family Health CareTerminated
Baldwin, Michigan, United States
Grace HealthRecruiting
Battle Creek, Michigan, United States
Genesee Community Health CenterRecruiting
Flint, Michigan, United States
Hamilton Community Health NetworkRecruiting
Flint, Michigan, United States
Cherry HealthRecruiting
Grand Rapids, Michigan, United States
MidMichigan Community Health ServicesRecruiting
Houghton Lake, Michigan, United States
Upper Great Lakes Family Health Care CenterRecruiting
Menominee, Michigan, United States
Family Medical Center of MichiganRecruiting
Monroe, Michigan, United States
Sterling Area Health CenterRecruiting
Sterling, Michigan, United States
Family Care Health CentersRecruiting
St Louis, Missouri, United States
Western North Carolina Community Health ServicesRecruiting
Asheville, North Carolina, United States
CommUnityCare Health CentersRecruiting
Austin, Texas, United States
Unity Care NWRecruiting
Bellingham, Washington, United States
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers · TrialPath