Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
2 other identifiers
interventional
430
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2022
CompletedFirst Submitted
Initial submission to the registry
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 14, 2025
August 1, 2025
3.9 years
July 11, 2022
August 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5)
The CAPS-5 is a clinician-rated PTSD rating scale consisting of 30 items; the total score is calculated as the sum of 20 items assessing the 20 DSM-5 PTSD symptoms. These symptom items are scored on a 5-point scale from 0 (absent) to 4 (extreme/incapacitating). The total score of the 20 items ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. Therefore, a decrease in the total score indicates symptom improvement.
Baseline, 3-months
Secondary Outcomes (3)
Change in PTSD symptoms by the PTSD Checklist (PCL-5)
Baseline, 3-months
Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)
Baseline, 3-months
Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)
Baseline, 3-months
Study Arms (6)
Prolonged Exposure for Primary Care (PE-PC) then continue as early responder
EXPERIMENTALPE-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).
Clinician Supported (CS) PTSD Coach App then continue as early responder
EXPERIMENTALDuring 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.
Prolonged Exposure for Primary Care (PE-PC) then full PE
EXPERIMENTALPE-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.
Clinician Supported PTSD Coach App then full PE
EXPERIMENTALDuring 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.
Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC
EXPERIMENTALPE-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.
Clinician Supported PTSD Coach App then continued CS PTSD Coach App
EXPERIMENTALDuring 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.
Interventions
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.
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Mental Health (NIMH)collaborator
- University of Michiganlead
Study Sites (13)
Family Health Care
Baldwin, Michigan, 49304, United States
Grace Health
Battle Creek, Michigan, 49037, United States
Genesee Community Health Center
Flint, Michigan, 48503, United States
Hamilton Community Health Network
Flint, Michigan, 48503, United States
Cherry Health
Grand Rapids, Michigan, 49503, United States
MidMichigan Community Health Services
Houghton Lake, Michigan, 48629, United States
Upper Great Lakes Family Health Care Center
Menominee, Michigan, 49858, United States
Family Medical Center of Michigan
Monroe, Michigan, 48162, United States
Sterling Area Health Center
Sterling, Michigan, 48659, United States
Family Care Health Centers
St Louis, Missouri, 63111, United States
Western North Carolina Community Health Services
Asheville, North Carolina, 28801, United States
CommUnityCare Health Centers
Austin, Texas, 78702, United States
Unity Care NW
Bellingham, Washington, 98225, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The primary outcome, the Clinician-Administered PTSD Scale (CAP-5), will be administered by a blinded study team member.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 14, 2022
Study Start
June 23, 2022
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share