Recruiting

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

Sponsor:

University of Michigan

Code:

NCT05457985

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prolonged Exposure for Primary Care (PE-PC)

Full Prolonged Exposure

Clinician Supported PTSD Coach App

Study Details

Brief 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.

Conditions

PTSD

Study ID

NCT05457985

Start date

Jun 23, 2022

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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
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.

Study Design

Enrollment

430 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prolonged Exposure for Primary Care (PE-PC) then continue as early responder

PE-PC consists of four weekly 30-minute sessions. 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 (for 8 weeks).

experimental: Clinician Supported (CS) PTSD Coach App then continue as early responder

During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first). Early responders will be encouraged to continue app use but will discontinue clinician support sessions for the remaining 8 weeks.

experimental: Prolonged Exposure for Primary Care (PE-PC) then full PE

PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to full PE and will have sessions once a week for eight weeks. During these 60-minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.

experimental: Clinician Supported PTSD Coach App then full PE

During the first stage of treatment, participants will receive four weekly clinician support sessions or 9 weeks (whichever occurs first), slow responders that are then randomized to full PE will have sessions once a week for eight weeks. During these 60 minute sessions, participants will practice in vivo and imaginal exposure and continue these exposure exercises every day at home.

experimental: Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC

PE-PC consists of four weekly 30-minute sessions. At the 4th session or 9-week assessment point (whichever comes first), slow responders that are then randomized to continue with PE-PC (medium intensity) will continue weekly sessions for 8 weeks.

experimental: Clinician Supported PTSD Coach App then continued CS PTSD Coach App

Interventions

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.

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.

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.

Primary outcome measure

Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) [ Time Frame: Baseline, 3-months ]

Central Contacts and Locations

Central contacts

Kayla Longuski, MS

734-647-6258 kaylsmit@umich.edu

Heather Walters

734-845-3650 heawalte@umich.edu

Locations

Grace Health

Recruiting

Battle Creek, Michigan, United States, 49037

Principal Investigator:

Eric Macleod

Genesee Community Health Center

Recruiting

Flint, Michigan, United States, 48503

Hamilton Community Health Network

Recruiting

Flint, Michigan, United States, 48503

Principal Investigator:

Albert Ujkaj

Cherry Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Eric Achtyes

MidMichigan Community Health Services

Recruiting

Houghton Lake, Michigan, United States, 48629

Principal Investigator:

Stacey Gedeon

Upper Great Lakes Family Health Care Center

Recruiting

Menominee, Michigan, United States, 49858

Principal Investigator:

Donald Simila

Family Medical Center of Michigan

Recruiting

Monroe, Michigan, United States, 48162

Principal Investigator:

Erica Keith

Sterling Area Health Center

Recruiting

Sterling, Michigan, United States, 48659

Principal Investigator:

Linda LaTulip

Family Care Health Centers

Recruiting

St Louis, Missouri, United States, 63111

Principal Investigator:

Jordanna Riebel

Western North Carolina Community Health Services

Recruiting

Asheville, North Carolina, United States, 28801

Principal Investigator:

Jessica Parsil

CommUnityCare Health Centers

Recruiting

Austin, Texas, United States, 78702

Principal Investigator:

Heather Gause

Unity Care NW

Recruiting

Bellingham, Washington, United States, 98225

Principal Investigator:

Beth Williams

More Information

Sponsor

University of Michigan

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

Prolonged Exposure for Primary Care
Mobile device
Clinician Supported PTSD Coach App
PTSD symptoms
Prolonged Exposure/PE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-01.