Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
NCT ID: NCT05457985
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
430 participants
INTERVENTIONAL
2022-06-23
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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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).
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.
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.
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.
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.
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 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.
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.
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.
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.
Clinician Supported PTSD Coach App then continued CS PTSD Coach App
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 continue this treatment will have the frequency reduced to twice monthly.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Michigan
OTHER
Responsible Party
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Rebecca Sripada
Associate Professor of Psychiatry
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Eric Macleod
Role: primary
Brian Nicholson
Role: primary
Albert Ujkaj
Role: primary
Lindsey Metts
Role: primary
Stacey Gedeon
Role: primary
Savanna Weber
Role: primary
Erica Keith
Role: primary
Linda LaTulip
Role: primary
Jordanna Riebel
Role: primary
Jessica Parsil
Role: primary
Heather Gause
Role: primary
Beth Williams
Role: primary
Other Identifiers
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HUM00203165
Identifier Type: -
Identifier Source: org_study_id
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