PORTAL-PTSD for Post-Traumatic Stress Disorder
(PORTAL-PTSD Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byNeda Laiteerapong, MD, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
No Placebo Group
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.
12345What 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.
678910Eligibility 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
I am 18 years old or older.
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
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: PORTAL-PTSD InterventionExperimental Treatment1 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 InterventionActive Control1 Intervention
Standard of care offered to all patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CFHC Chicago LawnChicago, IL
CFHC RoselandChicago, IL
CFHC East ChicagoChicago, IL
CFHC South ChicagoChicago, IL
More Trial Locations
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
Chicago Family Health CenterCollaborator
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Personalization of Treatment for Patients with Childhood-Abuse-Related Posttraumatic Stress Disorder. [2021]Differences in effectiveness among treatments for posttraumatic stress disorder (PTSD) are typically small. Given the variation between patients in treatment response, personalization offers a new way to improve treatment outcomes. The aim of this study was to identify predictors of psychotherapy outcome in PTSD and to combine these into a personalized advantage index (PAI).
Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. [2014]To summarize the available evidence on the effectiveness of psychological interventions for patients with post-traumatic stress disorder (PTSD).
Randomized controlled trial of Internet-delivered cognitive behavioral therapy for posttraumatic stress disorder. [2022]Posttraumatic stress disorder (PTSD) is a severe and disabling condition and few receive appropriate care. Internet-based treatment of PTSD shows promise in reducing barriers to care and preliminary evidence suggests it is efficacious in treating symptoms of PTSD.
Long-term outcome of early interventions to prevent posttraumatic stress disorder. [2018]Failing to prevent posttraumatic stress disorder (PTSD) has major clinical and public health consequences. This work evaluates the 3-year outcome of offering early interventions to survivors with acute PTSD.
Feasibility of an intensive outpatient treatment program for posttraumatic stress disorder within the veterans health care administration. [2023]Trauma-focused treatments for posttraumatic stress disorder (PTSD), such as Prolonged Exposure (PE) therapy and Cognitive Processing Therapy (CPT), are effective and supported by various Clinical Practice Guidelines; however, drop-out rates for the treatments are as high as 40% within clinical programs. One promising solution is delivering the evidence-based psychotherapies (EBPs) three or more times per week within an intensive outpatient program (IOP) for PTSD. The present study examined the feasibility and effectiveness of a relatively low-resourced PTSD IOP within a larger PTSD program at the Veterans Healthcare Administration. The intensive program offers two tracks (2 week or 4 week) grounded in the massed delivery of PE and CPT. Over a 12-month period, 351 veterans completed an assessment for PTSD and 172 started within one of the local PTSD programs (e.g., weekly, IOP, or residential). Results of the study demonstrated that the IOP is an acceptable (i.e., 87.3% completion rate) and effective (e.g., PTSD Checklist for Diagnostic and Statistical Manual [DSM-5] [PCL-5] decrease effect size d = 1.80) treatment option. There was also adequate demand for the program (e.g., 37.2% of patients engaged in care with the PTSD programs started the IOP), and the program was implemented with fidelity to the design. Taken together, the results of this study demonstrate that this low-resource IOP model is a promising approach to improve completion rates within the continuum of care for the treatment of PTSD. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Exploring the experience of boarded psychiatric patients in adult emergency departments. [2021]This study quantifies the frequency of adverse events (AEs) experienced by psychiatric patients while boarded in the emergency department (ED) and describes those events over a broad range of categories.
Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]Adverse drug events (ADEs) present the greatest risk of harm to patients in hospitals, especially those receiving neuropsychiatric treatment. The objective of the present record-based study was to test the appropriateness of the neuropsychiatry trigger tool (NPTT) to identify and measure harm due to adverse events (AEs).
Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]Adverse Events (AEs) are defined as any unfavorable and unintended sign or symptom, that may occur during or after receipt of any intervention. The principle of non-maleficence requires careful consideration to ensure that existing or new psychological interventions are not harmful before they can be considered beneficial. In this context, the safety of psychological interventions, including the possible occurrence of AEs, is increasingly important for patients, families, and clinicians. The evaluation of AEs is crucial to obtain a complete understanding of the risk/benefit balance of psychological interventions. There is a need for researchers and clinicians to assess and report AEs comprehensively and in a coordinated manner. It is necessary to have more accurate data on the recording of AEs in protocols to enhance transparency and consistency, as well as to improve practice. Finally, and to facilitate this process, there is a need for standards for data collection.
Strategies for safety reporting in substance abuse trials. [2013]Reporting all adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials has yielded limited relevant safety information and has been burdensome to research sites.
Critical incident stress debriefing after adverse patient safety events. [2018]Adverse events (AEs) are common, estimated to occur in around 10% internationally. Although preventable harm can be minimized, when AEs occur it is important that they be managed appropriately. AEs can be traumatic not only for patients, their friends, and relatives, but also for the involved clinicians, who have been referred to as "second victims" in a growing body of international research. Despite the frequency with which AEs occur, organizational mechanisms for supporting staff in these circumstances are not routinely embedded in healthcare settings. Critical Incident Stress Debriefing (CISD) has long been provided for professionals, such as disaster workers, who are exposed to traumatic and high-stress events. CISD is considered an effective strategy to promote resilience and recovery. We explore the potential value of providing CISD for health professionals involved in patient safety-related AEs and discuss the instances in which this could be routinely implemented.
Dose response characteristics of a novel CCD camera-based electronic portal imaging device comparison with OCTAVIUS detector. [2016]Dosimetric properties of a CCD camera-based Electronic Portal Imaging Device (EPID) for clinical dosimetric application have been evaluated. Characteristics obtained by EPID also compared with commercial 2D array of ion chambers.
Validation of Three-dimensional Electronic Portal Imaging Device-based PerFRACTION™ Software for Patient-Specific Quality Assurance. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">PerFRACTION™ is a three-dimensional (3D) in vivo electronic portal imaging device-based dosimetry software. To validate the software, three phantoms with different inserts (2D array, ionization chamber, and inhomogeneity materials) were constructed to evaluate point dose and fluence map.
Fast transit portal dosimetry using density-scaled layer modeling of aSi-based electronic portal imaging device and Monte Carlo method. [2017]Fast and accurate transit portal dosimetry was investigated by developing a density-scaled layer model of electronic portal imaging device (EPID) and applying it to a clinical environment.
Portal imaging. [2004]Portal imaging is the acquisition of images with a radiotherapy beam. Imaging theory suggests that the quality of portal images could be much higher if the efficiency of the imaging media in detecting radiation could be improved. Introduction of new media (films and electronic portal imaging devices) has confirmed this by markedly increasing the quality of portal images. Images from these devices can then be used to verify a patient's treatment. Geometric verification requires the portal image to be registered with a reference image. Dosimetric verification requires the portal imager to be calibrated for dose. This review gives a brief overview of the current areas of interest in portal imaging: imaging theory; imaging media, film and electronic portal imaging devices; image registration; and dosimetry using these devices.
Introduction of a novel dose saving acquisition mode for the PortalVision aS500 EPID to facilitate on-line patient setup verification. [2019]In external beam radiotherapy, electronic portal imaging becomes more and more an indispensable tool for the verification of the patient setup. For the safe clinical introduction of high dose conformal radiotherapy like intensity modulated radiation therapy, on-line patient setup verification is a prerequisite to ensure that the planned dosimetric coverage of the tumor volume is actually realized in the patient. Since the direction of setup fields often deviates from the direction of the treatment beams, extra dose is delivered to the patient during the acquisition of these portal images which may reach clinical relevance. The aim of this work was to develop a new acquisition mode for the PortalVision aS500 electronic portal imaging device from Varian Medical Systems that allows one to take portal images with reduced dose while keeping good image quality. The new acquisition mode, called RadMode, selectively enables and disables beam pulses during image acquisition allowing one to stop wasting valuable dose during the initial acquisition of "reset frames." Images of excellent quality can be taken with 1 MU only. This low dose per image facilitates daily setup verification with considerably reduced extra dose.