PTSDPORTAL-PTSDNCT06479447
Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder
A study testing PORTAL-PTSD in people with PTSD, run by University of Chicago at 2 sites in United States.
Trial summary
This study aims to implement and evaluate a more timely approach to post-traumatic stress disorder (PTSD) diagnosis and management, entitled Patient Outcome Reporting for Timely Assessments of Life with Post-Traumatic Stress Disorder (PORTAL-PTSD) in a primary care setting with a high prevalence of trauma… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- PORTAL-PTSD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2024to 14 Jul 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
CFHC South Chicago
Chicago, Illinois, 60617
Melissa Duplantis, 773-768-5000, mduplantis@chicagofamilyhealth.org
- Recruiting
CFHC Chicago Lawn
Chicago, Illinois, 60629
Melissa Duplantis, PsyD, 773-768-5000, mduplantis@chicagofamilyhealth.org
About this study
This study aims to implement and evaluate a more timely approach to post-traumatic stress disorder (PTSD) diagnosis and management, entitled Patient Outcome Reporting for Timely Assessments of Life with Post-Traumatic Stress Disorder (PORTAL-PTSD) in a primary care setting with a high prevalence of trauma, specifically the South Side of Chicago, in partnership with Chicago Family Health Center (CFHC).
Read the detailed description
Traumatic stress and post-traumatic stress disorder (PTSD) are highly prevalent and lead to increases in psychiatric and cardiovascular disease. People residing in environments entrenched in community violence or experiencing assault are at especially high risk of PTSD. However, many people with PTSD are not diagnosed or treated. Current practices for identifying PTSD are subject to bias because diagnosis depends on clinician- or patient-initiated discussion of trauma-related symptoms, and stigma, knowledge, time, and access to resources are often obstacles to these discussions. System-level solutions are needed to increase diagnosis and treatment of PTSD. Systematic screening protocols can help address bias in who is screened. A keystone to screening for PTSD could be to screen patients when they are at clinic visits. While no formal recommendation exists for PTSD screening, clinics who serve patients at a high risk for PTSD, for example, the Veterans Affairs, have implemented screening at clinic visits. Use of patient portals may provide another promising strategy to address barriers to PTSD screening. In the investigators' previous work, a population health approach was used to screen for and assess depression symptoms, employing the patient portal as a tool to reach out to patients. The investigators found that it resulted in a higher screening rate and identified more patients with moderate-severe depression. After identifying patients with PTSD, the next necessary step is to provide evidence-based treatments, like integrated primary-care behavioral health (PCBH). Integrated primary care-behavioral health (PCBH) is a model of care in which the behavioral health and primary care teams are collocated with the primary care clinic and work together to address the biopsychosocial factors that are affecting a patient's health. PCBH has been found to be less stigmatizing for patients with PTSD and models of care that are proactive and provide telephonic care management have been found to increase treatment engagement for PTSD. Thus, coupling screening for PTSD with a PCBH model may be a highly effective strategy to improving PTSD outcomes. Therefore, the investigators' goal is to implement and evaluate a novel strategy for screening and management of PTSD in a primary care setting with a high prevalence of trauma, specifically the South Side of Chicago. In partnership with Chicago Family Health Center, a federally qualified health center (FQHC) with 5 clinical sites and PCBH, the investigators aim to 1) Implement a system-level screening and management strategy for PTSD. The investigators will implement a process of clinic visit and population health screening for PTSD leveraging the patient portal with linkage to care within a PCBH model and 2) Evaluate a system-level screening and management strategy for PTSD. With these aims, this grant will lead to increased understanding of the utility and feasibility of screening and managing PTSD in an FQHC that serves a population with high rates of trauma exposure. If proven effective, the investigators will evaluate this model of care in a multi-center trial of FQHCs.
- Conditions
- PTSD
- Being tested
- PORTAL-PTSD
- Keywords
- behavioral health, PTSD, PTSD screening
- 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.
PORTAL-PTSDOther
Patients will be eligible if they are 18+ years, have had a primary care visit in the last 2 years, and have not been screened for PTSD in the last year. The validated PC-PTSD-5 (Primary Care Post Traumatic Stress Disorder-5) screener will be used. Clinics will implement visit-based and population health screening for patients enrolled in the patient portal who have not been screened for PTSD in the last year and have had a clinic appointment in the last 2 years. The PCBH care manager or patient navigator will follow-up with patients every 2 weeks to ensure they have been connected to care and re-measure their PTSD symptoms. The follow-up calls will continue until symptom remission, after which follow-ups will occur quarterly for 6 months. Primary care clinicians will receive training on trauma-informed care and PTSD management, and will be surveyed at baseline, immediately after training, and 6 months-post intervention to evaluate changes in their knowledge of trauma-informed care.
| Study group | Role | What they receive |
|---|---|---|
| PORTAL-PTSD Intervention | Experimental | Chicago Family Health Center clinics are randomly assigned to any of the 5 steps. The PORTAL-PTSD intervention is implemented after clinic staff and clinicians have been trained. Receives: Other: PORTAL-PTSD |
| No PORTAL-PTSD Intervention | No intervention | Standard of care offered to all patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD screening rates
Number and proportion of patients who were screened for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5).
Measured: every 6 months post-intervention for 2 years
PTSD diagnoses rates
Number and proportion of patients who screen positive for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5).
Measured: every 6 months post-intervention for 2 years
PTSD prescribed treatment rates
Treatment rate is measured as proportion of patients with PTSD and prescribed treatment out of total patients diagnosed with PTSD. Receipt of treatment is defined by completion of PCBH services or at least 3-months of therapy for PTSD for patients who choose to not receive PCBH services.
Measured: every 6 months post-intervention for 2 years
PTSD symptoms severity
Patient-reported improvement in PTSD symptoms severity as measured by the 20-item Post-Traumatic Stress Disorder Checklist (PCL).
Measured: every 6 months post-intervention for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Jul 2024
- Primary completion14 Jul 2026 (estimated)
- Study completion14 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Chicago Family Health Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Neda Laiteerapong, MD, MS, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479447
- Sponsor's protocol ID
- IRB23-1759
- Other IDs
- 5P50MD017349-04
- Acronym
- PORTAL-PTSD
- Status last verified
- May 2025
- First submitted
- 24 Jun 2024
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mensah GA, Collins PY. Understanding mental health for the prevention and control of cardiovascular diseases. Glob Heart. 2015 Sep;10(3):221-4. doi: 10.1016/j.gheart.2015.08.003.
PubMed 26407518Druss BG, Zhao L, Von Esenwein S, Morrato EH, Marcus SC. Understanding excess mortality in persons with mental illness: 17-year follow up of a nationally representative US survey. Med Care. 2011 Jun;49(6):599-604. doi: 10.1097/MLR.0b013e31820bf86e.
PubMed 21577183Beristianos MH, Yaffe K, Cohen B, Byers AL. PTSD and Risk of Incident Cardiovascular Disease in Aging Veterans. Am J Geriatr Psychiatry. 2016 Mar;24(3):192-200. doi: 10.1016/j.jagp.2014.12.003. Epub 2014 Dec 9.
PubMed 25555625O'Donnell CJ, Schwartz Longacre L, Cohen BE, Fayad ZA, Gillespie CF, Liberzon I, Pathak GA, Polimanti R, Risbrough V, Ursano RJ, Vander Heide RS, Yancy CW, Vaccarino V, Sopko G, Stein MB. Posttraumatic Stress Disorder and Cardiovascular Disease: State of the Science, Knowledge Gaps, and Research Opportunities. JAMA Cardiol. 2021 Oct 1;6(10):1207-1216. doi: 10.1001/jamacardio.2021.2530.
PubMed 34259831Liu MY, Li N, Li WA, Khan H. Association between psychosocial stress and hypertension: a systematic review and meta-analysis. Neurol Res. 2017 Jun;39(6):573-580. doi: 10.1080/01616412.2017.1317904. Epub 2017 Apr 17.
PubMed 28415916Wirtz PH, von Kanel R. Psychological Stress, Inflammation, and Coronary Heart Disease. Curr Cardiol Rep. 2017 Sep 20;19(11):111. doi: 10.1007/s11886-017-0919-x.
PubMed 28932967Hackett RA, Steptoe A. Type 2 diabetes mellitus and psychological stress - a modifiable risk factor. Nat Rev Endocrinol. 2017 Sep;13(9):547-560. doi: 10.1038/nrendo.2017.64. Epub 2017 Jun 30.
PubMed 28664919Kubzansky LD, Koenen KC, Spiro A 3rd, Vokonas PS, Sparrow D. Prospective study of posttraumatic stress disorder symptoms and coronary heart disease in the Normative Aging Study. Arch Gen Psychiatry. 2007 Jan;64(1):109-16. doi: 10.1001/archpsyc.64.1.109.
PubMed 17199060Coughlin SS. Post-traumatic Stress Disorder and Cardiovascular Disease. Open Cardiovasc Med J. 2011;5:164-70. doi: 10.2174/1874192401105010164. Epub 2011 Jul 11.
PubMed 21792377Schein J, Houle C, Urganus A, Cloutier M, Patterson-Lomba O, Wang Y, King S, Levinson W, Guerin A, Lefebvre P, Davis LL. Prevalence of post-traumatic stress disorder in the United States: a systematic literature review. Curr Med Res Opin. 2021 Dec;37(12):2151-2161. doi: 10.1080/03007995.2021.1978417. Epub 2021 Sep 23.
PubMed 34498953
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcome Reporting for Timely Assessments of Life With Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06479447
- Acronym / sponsor ID
- PORTAL-PTSD / IRB23-1759
- Conditions
- PTSD
- Keywords
- behavioral health, PTSD, PTSD screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17,000 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Chicago Family Health Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 14 Jul 2026 (estimated)
- Study completion
- 14 Jul 2026 (estimated)
- First posted
- 28 Jun 2024 (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 study aims to implement and evaluate a more timely approach to post-traumatic stress disorder (PTSD) diagnosis and management, entitled Patient Outcome Reporting for Timely Assessments of Life with Post-Traumatic Stress Disorder (PORTAL-PTSD) in a primary care setting with a high prevalence of trauma, specifically the South Side of Chicago, in partnership with Chicago Family Health Center (CFHC).
Detailed description
Traumatic stress and post-traumatic stress disorder (PTSD) are highly prevalent and lead to increases in psychiatric and cardiovascular disease. People residing in environments entrenched in community violence or experiencing assault are at especially high risk of PTSD. However, many people with PTSD are not diagnosed or treated. Current practices for identifying PTSD are subject to bias because diagnosis depends on clinician- or patient-initiated discussion of trauma-related symptoms, and stigma, knowledge, time, and access to resources are often obstacles to these discussions. System-level solutions are needed to increase diagnosis and treatment of PTSD. Systematic screening protocols can help address bias in who is screened. A keystone to screening for PTSD could be to screen patients when they are at clinic visits. While no formal recommendation exists for PTSD screening, clinics who serve patients at a high risk for PTSD, for example, the Veterans Affairs, have implemented screening at clinic visits. Use of patient portals may provide another promising strategy to address barriers to PTSD screening. In the investigators' previous work, a population health approach was used to screen for and assess depression symptoms, employing the patient portal as a tool to reach out to patients. The investigators found that it resulted in a higher screening rate and identified more patients with moderate-severe depression. After identifying patients with PTSD, the next necessary step is to provide evidence-based treatments, like integrated primary-care behavioral health (PCBH). Integrated primary care-behavioral health (PCBH) is a model of care in which the behavioral health and primary care teams are collocated with the primary care clinic and work together to address the biopsychosocial factors that are affecting a patient's health. PCBH has been found to be less stigmatizing for patients with PTSD and models of care that are proactive and provide telephonic care management have been found to increase treatment engagement for PTSD. Thus, coupling screening for PTSD with a PCBH model may be a highly effective strategy to improving PTSD outcomes. Therefore, the investigators' goal is to implement and evaluate a novel strategy for screening and management of PTSD in a primary care setting with a high prevalence of trauma, specifically the South Side of Chicago. In partnership with Chicago Family Health Center, a federally qualified health center (FQHC) with 5 clinical sites and PCBH, the investigators aim to 1) Implement a system-level screening and management strategy for PTSD. The investigators will implement a process of clinic visit and population health screening for PTSD leveraging the patient portal with linkage to care within a PCBH model and 2) Evaluate a system-level screening and management strategy for PTSD. With these aims, this grant will lead to increased understanding of the utility and feasibility of screening and managing PTSD in an FQHC that serves a population with high rates of trauma exposure. If proven effective, the investigators will evaluate this model of care in a multi-center trial of FQHCs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PORTAL-PTSD Intervention | Experimental | Other: PORTAL-PTSDChicago Family Health Center clinics are randomly assigned to any of the 5 steps. The PORTAL-PTSD intervention is implemented after clinic staff and clinicians have been trained. |
| No PORTAL-PTSD Intervention | No intervention | –Standard of care offered to all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| PORTAL-PTSDPatients will be eligible if they are 18+ years, have had a primary care visit in the last 2 years, and have not been screened for PTSD in the last year. The validated PC-PTSD-5 (Primary Care Post Traumatic Stress Disorder-5) screener will be used. Clinics will implement visit-based and population health screening for patients enrolled in the patient portal who have not been screened for PTSD in the last year and have had a clinic appointment in the last 2 years. The PCBH care manager or patient navigator will follow-up with patients every 2 weeks to ensure they have been connected to care and re-measure their PTSD symptoms. The follow-up calls will continue until symptom remission, after which follow-ups will occur quarterly for 6 months. Primary care clinicians will receive training on trauma-informed care and PTSD management, and will be surveyed at baseline, immediately after training, and 6 months-post intervention to evaluate changes in their knowledge of trauma-informed care. | Other | PORTAL-PTSD Intervention |
Primary outcome
PTSD screening rates
Time frame: every 6 months post-intervention for 2 years
Number and proportion of patients who were screened for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5).
PTSD diagnoses rates
Time frame: every 6 months post-intervention for 2 years
Number and proportion of patients who screen positive for PTSD, as determined by the validated Primary Care Post-Traumatic Stress Disorder screener (PC-PTSD-5).
PTSD prescribed treatment rates
Time frame: every 6 months post-intervention for 2 years
Treatment rate is measured as proportion of patients with PTSD and prescribed treatment out of total patients diagnosed with PTSD. Receipt of treatment is defined by completion of PCBH services or at least 3-months of therapy for PTSD for patients who choose to not receive PCBH services.
PTSD symptoms severity
Time frame: every 6 months post-intervention for 2 years
Patient-reported improvement in PTSD symptoms severity as measured by the 20-item Post-Traumatic Stress Disorder Checklist (PCL).
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 10 Nov 2025.
- Background: PubMed 26407518Mensah GA, Collins PY. Understanding mental health for the prevention and control of cardiovascular diseases. Glob Heart. 2015 Sep;10(3):221-4. doi: 10.1016/j.gheart.2015.08.003.
- Background: PubMed 21577183Druss BG, Zhao L, Von Esenwein S, Morrato EH, Marcus SC. Understanding excess mortality in persons with mental illness: 17-year follow up of a nationally representative US survey. Med Care. 2011 Jun;49(6):599-604. doi: 10.1097/MLR.0b013e31820bf86e.
- Background: PubMed 25555625Beristianos MH, Yaffe K, Cohen B, Byers AL. PTSD and Risk of Incident Cardiovascular Disease in Aging Veterans. Am J Geriatr Psychiatry. 2016 Mar;24(3):192-200. doi: 10.1016/j.jagp.2014.12.003. Epub 2014 Dec 9.
- Background: PubMed 34259831O'Donnell CJ, Schwartz Longacre L, Cohen BE, Fayad ZA, Gillespie CF, Liberzon I, Pathak GA, Polimanti R, Risbrough V, Ursano RJ, Vander Heide RS, Yancy CW, Vaccarino V, Sopko G, Stein MB. Posttraumatic Stress Disorder and Cardiovascular Disease: State of the Science, Knowledge Gaps, and Research Opportunities. JAMA Cardiol. 2021 Oct 1;6(10):1207-1216. doi: 10.1001/jamacardio.2021.2530.
- Background: PubMed 28415916Liu MY, Li N, Li WA, Khan H. Association between psychosocial stress and hypertension: a systematic review and meta-analysis. Neurol Res. 2017 Jun;39(6):573-580. doi: 10.1080/01616412.2017.1317904. Epub 2017 Apr 17.
- Background: PubMed 28932967Wirtz PH, von Kanel R. Psychological Stress, Inflammation, and Coronary Heart Disease. Curr Cardiol Rep. 2017 Sep 20;19(11):111. doi: 10.1007/s11886-017-0919-x.
- Background: PubMed 28664919Hackett RA, Steptoe A. Type 2 diabetes mellitus and psychological stress - a modifiable risk factor. Nat Rev Endocrinol. 2017 Sep;13(9):547-560. doi: 10.1038/nrendo.2017.64. Epub 2017 Jun 30.
- Background: PubMed 17199060Kubzansky LD, Koenen KC, Spiro A 3rd, Vokonas PS, Sparrow D. Prospective study of posttraumatic stress disorder symptoms and coronary heart disease in the Normative Aging Study. Arch Gen Psychiatry. 2007 Jan;64(1):109-16. doi: 10.1001/archpsyc.64.1.109.
- Background: PubMed 21792377Coughlin SS. Post-traumatic Stress Disorder and Cardiovascular Disease. Open Cardiovasc Med J. 2011;5:164-70. doi: 10.2174/1874192401105010164. Epub 2011 Jul 11.
- Background: PubMed 34498953Schein J, Houle C, Urganus A, Cloutier M, Patterson-Lomba O, Wang Y, King S, Levinson W, Guerin A, Lefebvre P, Davis LL. Prevalence of post-traumatic stress disorder in the United States: a systematic literature review. Curr Med Res Opin. 2021 Dec;37(12):2151-2161. doi: 10.1080/03007995.2021.1978417. Epub 2021 Sep 23.
- Individual participant dataSharing planned: Undecided
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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.
Neda Laiteerapong, MD, MS principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PORTAL-PTSD in people with PTSD, run by University of Chicago at 2 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 0 inclusion and 1 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 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Ainur Kagarmanova, MS, MA (5742865712, akagarmanova@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD screening rates (time frame: every 6 months post-intervention for 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479447, which also lists 10 linked publications.
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 10 Nov 2025.