Actively Recruiting
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
N/A
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
Researchers are evaluating different approaches to talk therapy for patients with Posttraumatic Stress Disorder (PTSD) to find out which method works best. The study focuses on whether starting treatment with one type of therapy is more effective than starting with another, and whether switching therapies after four sessions helps more than continuing the same therapy. The goal is to reduce PTSD symptoms using a stepped-care model that adjusts treatment intensity based on early response. Participants receive one of two main behavioral treatments: Prolonged Exposure for Primary Care (PE-PC) or Clinician Supported PTSD Coach App therapy. PE-PC involves four weekly 30-minute sessions introducing exposure exercises, with adjustments after the fourth session or nine weeks based on response. Slow responders may continue with full Prolonged Exposure therapy, which includes eight weekly 60-minute sessions with daily exposure exercises at home. Early responders in either group may reduce session frequency during the second stage of treatment. During the study, participants' PTSD symptoms will be measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at baseline and three months. Additional assessments include self-reported PTSD symptoms, depression levels, and quality of life. The study involves regular clinician support sessions, app use, and exposure practices. Researchers aim to monitor symptom changes and treatment adherence over the course of therapy lasting up to 17 weeks, with randomized group assignments and single masking to help assess outcomes.
CONDITIONS
Brief Title
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
Who Can Participate
Eligibility Criteria
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 (2625) 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
- Adults aged 18 years or older
- English speaking
You will not qualify if you...
- Severe cognitive impairment making it unlikely to follow the study regimen
- High risk of suicide as defined by the Participant Suicide Risk Screening form
- Severe alcohol or substance use disorder (AUDIT score 2625 15 or NIDA Quick Screen score 2625 27)
- Active psychosis or unmanaged bipolar disorder
- Unstable housing
- Currently engaged in trauma-focused behavioral treatment (e.g., Prolonged Exposure or Cognitive Processing Therapy)
- Non-English speakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks
Participants receive initial treatment consisting of either four weekly 30-minute Prolonged Exposure for Primary Care (PE-PC) sessions or four weekly clinician-supported PTSD Coach App sessions, lasting up to 9 weeks.
Weekly visits for 4 weeks or up to 9 weeks depending on treatment and response
Duration - 8 weeks
Based on response, participants continue treatment: early responders on PE-PC receive every-other-week sessions for 8 weeks; early responders on the PTSD Coach App continue app use without clinician sessions; slow responders may switch to full Prolonged Exposure with weekly 60-minute sessions for 8 weeks or continue PE-PC or PTSD Coach App with adjusted session frequency.
Weekly or every-other-week visits depending on treatment arm
Duration - 3 months from baseline
Participants are assessed for changes in PTSD symptoms, depressive symptoms, and quality of life through standardized measures at baseline and at 3 months.
2 visits (baseline and 3-month follow-up)
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
Research Team
K
Kayla Longuski, MS
H
Heather Walters
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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