PORTAL-PTSD for Post-Traumatic Stress Disorder

(PORTAL-PTSD Trial)

Recruiting at 4 trial locations

Overseen By Ainur Kagarmanova, MS, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 3 months

17000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to diagnosing and managing post-traumatic stress disorder (PTSD) in a primary care setting. The researchers aim to determine if a method called PORTAL-PTSD can identify and treat PTSD more effectively, particularly in areas with high trauma rates like the South Side of Chicago. Participants will receive either standard care or the new PORTAL-PTSD intervention after clinic staff complete training. Those who have had an appointment at the study site in the last two years and have not been screened for PTSD in the past year may be eligible to participate. As an unphased trial, this study offers participants the chance to contribute to innovative PTSD care improvements in their community.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PORTAL-PTSD method is safe for PTSD management?

Research has shown that the PORTAL-PTSD treatment can reduce symptoms of PTSD, depression, and stress. This suggests the treatment is generally well-received and might be safe for participants. However, detailed safety information from past studies remains limited. Since this trial phase doesn't require extensive safety data, the treatment likely poses a low risk of serious side effects. Participants should discuss any concerns with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PORTAL-PTSD approach because it introduces an innovative method for addressing Post-Traumatic Stress Disorder. Unlike standard treatments like talk therapy or medication, PORTAL-PTSD involves a structured intervention implemented across clinics, which includes comprehensive training for clinic staff and clinicians. This method aims to enhance how PTSD care is delivered, potentially leading to more consistent and effective treatment outcomes for patients by integrating a team-based approach into everyday clinical practice.

What evidence suggests that the PORTAL-PTSD intervention might be an effective treatment for PTSD?

Research has shown that electronic patient portals can assist with mental health screenings, including for PTSD, by identifying individuals who might have PTSD more quickly and accurately. Early findings suggest that these portals can lead to better management of PTSD symptoms. In this trial, participants will receive either the PORTAL-PTSD intervention or standard care without the intervention. Proven methods like this have shown promise in real-world settings for improving outcomes for people with PTSD. Although more research is needed, these initial results are encouraging for using digital tools to manage PTSD. ^{2 3 6 7 8}

Who Is on the Research Team?

Neda Laiteerapong, MD, MS

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals who may have post-traumatic stress disorder (PTSD) and are receiving care in a primary care setting on the South Side of Chicago. The study is looking to include those who could benefit from a new approach to PTSD diagnosis and management.

Inclusion Criteria

Had an appointment at the study site in the last 24 months

Were not screened for PTSD in the last 12 months

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention Implementation

Implementation of the PORTAL-PTSD intervention after clinic staff and clinicians have been trained

Ongoing

Treatment

Participants receive evidence-based treatments like integrated primary-care behavioral health (PCBH) or at least 3-months of therapy for PTSD

3 months

Follow-up

Participants are monitored for PTSD diagnosis rates, screening rates, prescribed treatment rates, and symptoms severity

2 years

every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• PORTAL-PTSD

Trial Overview The PORTAL-PTSD intervention, which aims to improve the timeliness of PTSD diagnosis and treatment, is being tested among patients at the Chicago Family Health Center.

How Is the Trial Designed?

Group I: PORTAL-PTSD Intervention Experimental Treatment 1 Intervention

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.

Group II: No PORTAL-PTSD Intervention Active Control 1 Intervention

Standard of care offered to all patients

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Chicago Family Health Center

Collaborator

Trials

1

Recruited

17,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

The developed density-scaled layer model for electronic portal imaging devices (EPID) allows for fast and accurate transit dosimetry and dose reconstruction in clinical settings, achieving calculations in under 1 minute.

Validation of the model showed high accuracy, with gamma pass rates between 90.8% and 100% for various beam configurations, indicating its effectiveness in ensuring precise radiation delivery during treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast transit portal dosimetry using density-scaled layer modeling of aSi-based electronic portal imaging device and Monte Carlo method. Jung, JW., Kim, JO., Yeo, IJ., et al.[2017]

In a study of 200 psychiatric patients boarded in emergency departments, those who experienced adverse events (AEs) had a significantly longer average boarding time of 35 hours compared to 6.5 hours for those without AEs, indicating that longer stays may increase the risk of negative outcomes.

The research highlights that both the length of time patients spend in the emergency department and the duration of boarding after admission are critical factors that elevate the likelihood of experiencing adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the experience of boarded psychiatric patients in adult emergency departments. Major, D., Rittenbach, K., MacMaster, F., et al.[2021]

Adverse events (AEs) in healthcare are common, occurring in about 10% of cases, and can have significant emotional impacts not only on patients but also on the healthcare professionals involved, who may experience trauma as 'second victims'.

Implementing Critical Incident Stress Debriefing (CISD) for healthcare staff after AEs could be a valuable strategy to support their resilience and recovery, similar to its use in other high-stress professions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical incident stress debriefing after adverse patient safety events. Harrison, R., Wu, A.[2018]

The study evaluated the dosimetric properties of a CCD camera-based Electronic Portal Imaging Device (EPID) and found it to be well-suited for accurate dosimetric applications, with a high predictive accuracy for dose values below 50 cGy using a fourth order polynomial regression model.

While the EPID showed a slight nonlinearity in dose response that can be corrected, its performance was comparable to commercial 2D ion chamber arrays, although limitations exist due to integration time and dead-time during image acquisition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose response characteristics of a novel CCD camera-based electronic portal imaging device comparison with OCTAVIUS detector. Anvari, A., Aghamiri, SM., Mahdavi, SR., et al.[2016]

A systematic review of 66 trials involving 4190 patients with PTSD found that specific psychological interventions, such as cognitive behavioral therapy and exposure therapy, have large effect sizes, indicating they are effective in reducing PTSD symptoms.

No single psychological intervention was found to be consistently superior to others, but adherence to PTSD diagnostic criteria and trial quality were linked to larger effect sizes, suggesting that the effectiveness of these interventions can vary based on how well the trials are conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. Gerger, H., Munder, T., Gemperli, A., et al.[2014]

Portal imaging, which uses radiotherapy beams to create images, can achieve higher quality results with improved imaging media, such as advanced films and electronic devices.

These high-quality images are essential for verifying patient treatment through geometric and dosimetric verification, ensuring accurate and safe delivery of radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portal imaging. Langmack, KA.[2004]

A new imaging mode called RadMode for the PortalVision aS500 device allows for high-quality portal images to be taken with significantly reduced radiation dose, using only 1 MU per image.

This advancement enables safer daily patient setup verification in high dose conformal radiotherapy, minimizing unnecessary radiation exposure while maintaining effective imaging quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction of a novel dose saving acquisition mode for the PortalVision aS500 EPID to facilitate on-line patient setup verification. Vetterli, D., Riem, H., Aebersold, DM., et al.[2019]

In a study of 149 patients with childhood-abuse-related PTSD, specific predictors such as depressive symptoms and social support were identified that could help personalize treatment, leading to better outcomes.

Using a personalized advantage index (PAI) to match patients with optimal treatments resulted in significant improvements in PTSD symptoms, suggesting that personalized therapy could enhance effectiveness compared to standard approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalization of Treatment for Patients with Childhood-Abuse-Related Posttraumatic Stress Disorder. Hoeboer, CM., Oprel, DAC., De Kleine, RA., et al.[2021]

A study involving 42 individuals diagnosed with PTSD showed that Internet-based cognitive behavioral therapy (CBT) significantly reduced PTSD symptoms, depression, anxiety, and disability, indicating its potential effectiveness.

The treatment group experienced large improvements from pre- to post-treatment, while the differences between the treatment and waitlist control groups were small for PTSD symptoms but moderate for depression, anxiety, and disability, suggesting that Internet-based CBT can be a valuable option for those with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Internet-delivered cognitive behavioral therapy for posttraumatic stress disorder. Spence, J., Titov, N., Dear, BF., et al.[2022]

Early interventions like prolonged exposure therapy and cognitive therapy significantly reduced PTSD symptoms in the short term (1 to 5 months) for adults with acute PTSD, but did not lead to lower prevalence rates of PTSD after 3 years.

Despite the initial effectiveness of these therapies, the long-term outcomes showed similar levels of PTSD symptoms and prevalence across all treatment groups, indicating that some individuals may have persistent PTSD that is resistant to early interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of early interventions to prevent posttraumatic stress disorder. Shalev, AY., Ankri, Y., Gilad, M., et al.[2018]

An intensive outpatient program (IOP) for PTSD, offering Prolonged Exposure and Cognitive Processing Therapy three or more times a week, achieved a high completion rate of 87.3% among veterans, indicating strong acceptability.

The IOP demonstrated significant effectiveness, with a large effect size (d = 1.80) in reducing PTSD symptoms, suggesting it is a promising treatment option to enhance engagement and outcomes in PTSD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. Yamokoski, C., Flores, H., Facemire, V., et al.[2023]

PerFRACTION™ software demonstrated reliable and valid performance in measuring radiation doses during prostate treatment simulations, as confirmed by comparisons with ionization chamber measurements and other dosimetry methods.

The software showed close agreement with dose profiles from both measured and predicted values, indicating its potential effectiveness for accurate dosimetry in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Three-dimensional Electronic Portal Imaging Device-based PerFRACTION™ Software for Patient-Specific Quality Assurance. Sait, AA., Figueredo, J., Jones, GW., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06479447

Study Details | NCT06479447 | Patient Outcome Reporting ... This study aims to implement and evaluate a more timely approach to post-traumatic stress disorder (PTSD) diagnosis and management, entitled Patient Outcome ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228780/

The relation between passively collected data and PTSD Post-traumatic stress disorder (PTSD) is a common mental disorder. This systematic review and meta-analysis examined the association between ...

3. nature.com nature.com/articles/s41598-024-83144-6

Real-world evaluation of an evidence-based telemental ... This evaluation suggests BCT for PTSD symptoms can be beneficial in real-world settings. Future research should perform large-scale evaluations.

4. biologicalsciences.uchicago.edu biologicalsciences.uchicago.edu/news/electronic-patient-portals-improve-mental-health-screening-efforts

Electronic patient portals improve mental health screening ... Now that we are officially funded for the PORTAL-PTSD study, we're going to be ramping up our efforts at identifying patients with trauma across ...

5. ptsd.va.gov ptsd.va.gov/

PTSD: National Center for PTSD Home Posttraumatic stress disorder (PTSD) is a mental health problem that some people develop after experiencing or witnessing a life-threatening or traumatic event.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11286000/

The Trauma PORTAL—A Blended e-Health Intervention for ... Our secondary analysis revealed a significant decrease in PTSD symptoms and lower levels of depression and stress. Our results are similar to ...

7. who.int who.int/news-room/fact-sheets/detail/post-traumatic-stress-disorder

Post-traumatic stress disorder An estimated 3.9% of the world population has had post-traumatic stress disorder (PTSD) at some stage in their lives. Most people exposed to ...

8. mayoclinic.org mayoclinic.org/diseases-conditions/post-traumatic-stress-disorder/symptoms-causes/syc-20355967

Post-traumatic stress disorder (PTSD) - Symptoms and ... If you know someone who's in danger of attempting suicide or has made a suicide attempt, make sure someone stays with that person for safety.