Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05457985

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

Led by University of Michigan · Updated on 2025-08-14

430

Participants Needed

13

Research Sites

201 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment that makes adherence to the study regimen unlikely
  • High risk of suicide as defined by meeting criteria for Action Step 3 on the Participant Suicide Risk Screening form
  • Severe alcohol or substance use disorder (AUDIT score ≥ 15 or high risk on National Institute on Drug Abuse Quick Screen with score ≥ 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Family Health Care

Baldwin, Michigan, United States, 49304

Terminated

2

Grace Health

Battle Creek, Michigan, United States, 49037

Actively Recruiting

3

Genesee Community Health Center

Flint, Michigan, United States, 48503

Actively Recruiting

4

Hamilton Community Health Network

Flint, Michigan, United States, 48503

Actively Recruiting

5

Cherry Health

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

6

MidMichigan Community Health Services

Houghton Lake, Michigan, United States, 48629

Actively Recruiting

7

Upper Great Lakes Family Health Care Center

Menominee, Michigan, United States, 49858

Actively Recruiting

8

Family Medical Center of Michigan

Monroe, Michigan, United States, 48162

Actively Recruiting

9

Sterling Area Health Center

Sterling, Michigan, United States, 48659

Actively Recruiting

10

Family Care Health Centers

St Louis, Missouri, United States, 63111

Actively Recruiting

11

Western North Carolina Community Health Services

Asheville, North Carolina, United States, 28801

Actively Recruiting

12

CommUnityCare Health Centers

Austin, Texas, United States, 78702

Actively Recruiting

13

Unity Care NW

Bellingham, Washington, United States, 98225

Actively Recruiting

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Research Team

K

Kayla Longuski, MS

CONTACT

H

Heather Walters

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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