PTSDNCT05457985
Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder Treatment Outcomes in Federally Qualified Health Centers
A study testing Prolonged Exposure for Primary Care (PE-PC), Full Prolonged Exposure and Clinician Supported PTSD Coach App in people with PTSD, run by University of Michigan at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Prolonged Exposure for Primary Care (PE-PC), Full Prolonged Exposure and Clinician Supported PTSD Coach App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 13 sitesUnited States
- Study dates
- 23 Jun 2022to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 12 recruiting
- Recruiting
Western North Carolina Community Health Services
Asheville, North Carolina, 28801
Jessica Parsil
Jessica Parsil
- Recruiting
CommUnityCare Health Centers
Austin, Texas, 78702
Heather Gause
Heather Gause
- Terminated
Family Health Care
Baldwin, Michigan, 49304
- Recruiting
Grace Health
Battle Creek, Michigan, 49037
Eric Macleod
Eric Macleod
- Recruiting
Unity Care NW
Bellingham, Washington, 98225
Beth Williams
Beth Williams
- Recruiting
Genesee Community Health Center
Flint, Michigan, 48503
Brian Nicholson
- Recruiting
Hamilton Community Health Network
Flint, Michigan, 48503
Albert Ujkaj
Albert Ujkaj
- Recruiting
Cherry Health
Grand Rapids, Michigan, 49503
Lindsey Metts
Eric Achtyes
- Recruiting
MidMichigan Community Health Services
Houghton Lake, Michigan, 48629
Stacey Gedeon
Stacey Gedeon
- Recruiting
Upper Great Lakes Family Health Care Center
Menominee, Michigan, 49858
Savanna Weber
Donald Simila
- Recruiting
Family Medical Center of Michigan
Monroe, Michigan, 48162
Erica Keith
Erica Keith
- Recruiting
Family Care Health Centers
St Louis, Missouri, 63111
Jordanna Riebel
Jordanna Riebel
- Recruiting
Sterling Area Health Center
Sterling, Michigan, 48659
Linda LaTulip
Linda LaTulip
About this study
Official title: Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
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
- Being tested
- Prolonged Exposure for Primary Care (PE-PC), Full Prolonged Exposure, Clinician Supported PTSD Coach App
- Keywords
- Prolonged Exposure for Primary Care, Mobile device, Clinician Supported PTSD Coach App, PTSD symptoms, Prolonged Exposure/PE
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure for Primary Care (PE-PC)Behavioural
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 ExposureBehavioural
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 AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) then continue as early responder | Experimental | 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). Receives: Behavioral: Prolonged Exposure for Primary Care (PE-PC) |
| Clinician Supported (CS) PTSD Coach App then continue as early responder | Experimental | 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. Receives: Behavioral: Clinician Supported PTSD Coach App |
| Prolonged Exposure for Primary Care (PE-PC) then full PE | Experimental | 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. Receives: Behavioral: Prolonged Exposure for Primary Care (PE-PC); Behavioral: Full Prolonged Exposure |
| Clinician Supported PTSD Coach App then full PE | Experimental | 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. Receives: Behavioral: Full Prolonged Exposure; Behavioral: Clinician Supported PTSD Coach App |
| Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC | Experimental | 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. Receives: Behavioral: Prolonged Exposure for Primary Care (PE-PC) |
| Clinician Supported PTSD Coach App then continued CS PTSD Coach App | Experimental | 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. Receives: Behavioral: Clinician Supported PTSD Coach App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-months
Secondary outcomes (3)
Change in PTSD symptoms by the PTSD Checklist (PCL-5)
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity).
Measured: Baseline, 3-months
Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)
There are 9 questions that reflects the overall functioning and impairment due to the depressive symptoms. Scores ranges from 0 to 27, with a higher score indicating more severe symptoms.
Measured: Baseline, 3-months
Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)
The EQ-5D-5L assesses patients' overall quality of life and health. This measure asks questions related to mobility, self-care, activity, pain, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The participant indicates his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Higher scores mean better quality of life. Minimum score is 1 and the maximum score is 5 for each dimension. The measure also includes one 0-100 scale assessing how patients perceive their overall health.
Measured: Baseline, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start23 Jun 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- All eligible participants will initially be randomized to one of the two first-stage options, either PE-PC or PTSD coach with clinician support. Participants that have experienced less than a 15-point reduction, have a PCL score of greater than 60 ("very severe"), or cannot be reached for assessment will be classified as slow responders and will be re-randomized to one of two second-stage tactics, either (a) continue in their first-stage treatment strategy, or (b) step up to full PE. Participants who have experienced at least a 15-point symptom reduction or have a PCL score of less than 29 will be classified as early responders and will step down to a lower intensity of their current treatment strategy (i.e., early responders will not be re-randomized).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca Sripada, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457985
- Sponsor's protocol ID
- HUM00203165
- Other IDs
- 1R01MH125857-01A1
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Outcomes in Federally Qualified Health Centers
- ClinicalTrials.gov ID
- NCT05457985
- Acronym / sponsor ID
- HUM00203165
- Conditions
- PTSD
- Keywords
- Prolonged Exposure for Primary Care, Mobile device, Clinician Supported PTSD Coach App, PTSD symptoms, Prolonged Exposure/PE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- All eligible participants will initially be randomized to one of the two first-stage options, either PE-PC or PTSD coach with clinician support. Participants that have experienced less than a 15-point reduction, have a PCL score of greater than 60 ("very severe"), or cannot be reached for assessment will be classified as slow responders and will be re-randomized to one of two second-stage tactics, either (a) continue in their first-stage treatment strategy, or (b) step up to full PE. Participants who have experienced at least a 15-point symptom reduction or have a PCL score of less than 29 will be classified as early responders and will step down to a lower intensity of their current treatment strategy (i.e., early responders will not be re-randomized).
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure for Primary Care (PE-PC) then continue as early responder | Experimental | Behavioral: Prolonged Exposure for Primary Care (PE-PC)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). |
| Clinician Supported (CS) PTSD Coach App then continue as early responder | Experimental | Behavioral: Clinician Supported PTSD Coach AppDuring 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 | Experimental | Behavioral: Prolonged Exposure for Primary Care (PE-PC), Behavioral: Full Prolonged ExposurePE-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 | Experimental | Behavioral: Full Prolonged Exposure, Behavioral: Clinician Supported PTSD Coach AppDuring 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 | Experimental | Behavioral: Prolonged Exposure for Primary Care (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. |
| Clinician Supported PTSD Coach App then continued CS PTSD Coach App | Experimental | Behavioral: Clinician Supported PTSD Coach AppDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Prolonged Exposure for Primary Care (PE-PC) then continue as early responder, Prolonged Exposure for Primary Care (PE-PC) then continued PE-PC, Prolonged Exposure for Primary Care (PE-PC) then full PE |
| Full Prolonged ExposureTreatment 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. | Behavioural | Clinician Supported PTSD Coach App then full PE, Prolonged Exposure for Primary Care (PE-PC) then full PE |
| Clinician Supported PTSD Coach AppThis 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. | Behavioural | Clinician Supported (CS) PTSD Coach App then continue as early responder, Clinician Supported PTSD Coach App then continued CS PTSD Coach App, Clinician Supported PTSD Coach App then full PE |
Primary outcome
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
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.
3 secondary outcomes
Change in PTSD symptoms by the PTSD Checklist (PCL-5)
Time frame: Baseline, 3-months
Change in depressive symptoms measured by the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3-months
Change in quality of life and functioning measured by the EuroQol-5 Domain (EQ-5D-5L)
Time frame: Baseline, 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure for Primary Care (PE-PC), Full Prolonged Exposure and Clinician Supported PTSD Coach App in people with PTSD, run by University of Michigan at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Longuski, MS (734-647-6258, kaylsmit@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.