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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the idea that PORTAL-PTSD for Post-Traumatic Stress Disorder (also known as: PORTAL-PTSD) is an effective treatment?

The available research does not provide specific data on the effectiveness of PORTAL-PTSD for treating Post-Traumatic Stress Disorder. However, it mentions that trauma-focused treatments like Prolonged Exposure therapy and Cognitive Processing Therapy are effective, though they have high drop-out rates. An intensive outpatient program showed promise with a high completion rate and significant improvement in symptoms, suggesting that intensive and personalized approaches can be effective for PTSD treatment. ^{1 2 3 4 5}

What safety data exists for PORTAL-PTSD treatment?

The provided research does not contain specific safety data for PORTAL-PTSD treatment. It discusses adverse events in psychiatric settings, the need for accurate reporting of adverse events in psychological interventions, and strategies for safety reporting in substance abuse trials, but does not mention PORTAL-PTSD or related treatments directly. ^{6 7 8 9 10}

Is PORTAL-PTSD a promising treatment for Post-Traumatic Stress Disorder?

The information provided does not directly relate to PORTAL-PTSD as a treatment for Post-Traumatic Stress Disorder. The articles focus on electronic portal imaging devices used in radiotherapy, not on PTSD treatments. ^{11 12 13 14 15}

Research Team

Neda Laiteerapong, MD, MS

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Personalization of Treatment for Patients with Childhood-Abuse-Related Posttraumatic Stress Disorder. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of Internet-delivered cognitive behavioral therapy for posttraumatic stress disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome of early interventions to prevent posttraumatic stress disorder. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Exploring the experience of boarded psychiatric patients in adult emergency departments. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

9. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Critical incident stress debriefing after adverse patient safety events. [2018]

11. India pubmed.ncbi.nlm.nih.gov

Dose response characteristics of a novel CCD camera-based electronic portal imaging device comparison with OCTAVIUS detector. [2016]

12. India pubmed.ncbi.nlm.nih.gov

Validation of Three-dimensional Electronic Portal Imaging Device-based PerFRACTION™ Software for Patient-Specific Quality Assurance. [2022]

13. United States 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. [2017]

14. England pubmed.ncbi.nlm.nih.gov

Portal imaging. [2004]

15. United States 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. [2019]