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

ConditionPTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Prolonged Exposure for Primary Care (PE-PC)
  • Full Prolonged Exposure
  • Clinician Supported PTSD Coach App

Treatment groups

430 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Michigan

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator