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RECRUITING
NCT05457985
NA

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

Sponsor: University of Michigan

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

430

Start Date

2022-06-23

Completion Date

2026-05

Last Updated

2025-08-14

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Prolonged Exposure for Primary Care (PE-PC)

Treatment follows the standardized PE-PC manual and workbook.PE-PC consists of four weekly 30-minute sessions. In vivo and imaginal exposure are introduced at the first session and reviewed at Sessions 2-4. To conduct in vivo exposure, participants repeatedly and systematically approach objectively safe people, places, objects, and situations that they avoid because these stimuli remind them of their trauma. At the 4th session or 9-week assessment point (whichever comes first), early responders will step down to every-other-week sessions for the duration of the second stage.

BEHAVIORAL

Full Prolonged Exposure

Treatment will follow the standardized PE manual. Participants will have 60 minute sessions once a week for eight weeks During these sessions, participants will practice in vivo, imaginal, and emotional exposure as well as continue these exposure exercises every day at home.

BEHAVIORAL

Clinician Supported PTSD Coach App

This is a brief psychotherapy that uses the PTSD Coach mobile app developed by the study team. The PTSD Coach app incorporates evidence-based assessment, psychoeducation, and cognitive behavioral therapy and self-management strategies that are customizable to the user.

Locations (13)

Family Health Care

Baldwin, Michigan, United States

Grace Health

Battle Creek, Michigan, United States

Genesee Community Health Center

Flint, Michigan, United States

Hamilton Community Health Network

Flint, Michigan, United States

Cherry Health

Grand Rapids, Michigan, United States

MidMichigan Community Health Services

Houghton Lake, Michigan, United States

Upper Great Lakes Family Health Care Center

Menominee, Michigan, United States

Family Medical Center of Michigan

Monroe, Michigan, United States

Sterling Area Health Center

Sterling, Michigan, United States

Family Care Health Centers

St Louis, Missouri, United States

Western North Carolina Community Health Services

Asheville, North Carolina, United States

CommUnityCare Health Centers

Austin, Texas, United States

Unity Care NW

Bellingham, Washington, United States