RecruitingNot ApplicableNCT05457985

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

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


Sponsor

University of Michigan

Enrollment

430 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different combinations of care — including an app-based tool (PTSD Coach) and therapy — to improve treatment outcomes for people with PTSD who are seen at community health centers. Researchers want to find what works best for people who don't fully respond to first-line treatment. **You may be eligible if...** - You receive care at a participating community health center - You score 33 or higher on the PTSD checklist (PCL-5) - You own a smartphone or tablet that can run the PTSD Coach app - Your psychiatric medications (if any) have been stable for at least 1 month **You may NOT be eligible if...** - You are currently in an acute psychiatric crisis - You have a condition that makes app-based interventions unsuitable - Your medications are frequently changing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALProlonged 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.

BEHAVIORALFull 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.

BEHAVIORALClinician 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

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NCT05457985


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