This clinical trial is designed to pilot an electroretinogram (ERG) biomarker for predicting treatment response to SSRIs in PTSD. Serotonergic brain centers project to the retina, and ERG allows assessment of brain serotonergic signals via retinal signals. In this study we are characterizing the ERG waveform in veterans with PTSD before and after SSRI administration. Patients then enter an open label phase of the study, with those who have initiated an SSRI through routine medication management invited back for a follow up study visit. This pilot data will: 1)be valuable as a feasibility study for assessing the practical application of ERG in the setting of a mental health clinic and 2)serve as a foundation for a long-term goal of developing physiologic biomarkers to match veterans to corresponding pharmacological treatments in PTSD and other mental health disorders.
Targeted Condition: PTSD
Alcohol-focused Support of Survivors In Sororities Training (ASSIST)
The purpose of this study is to develop and evaluate a new online program called ASSIST – Alcohol-focused Support of Survivors In Sororities Training. The training is designed to help sorority members learn how to support friends who have had an unwanted sexual experience, both during the initial discussion of the experience and when navigating recovery in the longer-term. This multiphase study involves (1) developing the training in collaboration with students and campus stakeholders, (2) improving the training content and design through individual interviews with sorority members, (3) conducting an open trial of the training within one chapter, and then (4) conducting a pilot cluster randomized trial to evaluate feasibility and initial efficacy of the training. If found to be effective, this training could be widely disseminated and facilitate positive change in social contexts where survivors recover.
Identity, Resilience, and Interconnection after Stress (IRIS)
The IRIS Study is a longitudinal examination of young adults who have experienced an unwanted sexual experience in the past year, and those who have never had an unwanted sexual experience. This study aims to prospectively examine how young adults’ thoughts about a recent unwanted sexual experience are shaped by and influence social relationships and health-related behaviors over time. To do so, this multimethod study involves in-depth interviews, social network assessments, ecological momentary assessments, transdermal alcohol biosensors, and online surveys over one year. This study is conducted by researchers at both the University of Washington and the University of Nebraska-Lincoln.
THRIVE Study
This is a study of an app intended to support recent sexual assault survivors, called THRIVE. In a prior grant, we pilot tested THRIVE and found that it reduced risk for alcohol misuse and posttraumatic stress. In the first year of this grant, we aim to revise the app to increase usability and inclusivity. In the second through fifth years of the grant, we will conduct a larger randomized controlled trial of multiple versions of the app among college students who have experienced sexual assault in the past 12 weeks. This will allow us to identify the most effective and low-burden version of THRIVE. If we are successful in identifying a highly effective and efficient version of THRIVE, this intervention would represent a highly-scalable strategy to reduce the substantial burden of posttraumatic stress and alcohol misuse on student survivors and campus service systems.
Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD (PRIMED-PTSD)
PTSD is one of the most common mental health conditions affecting Veterans and is associated with significant burden. Highly effective treatments exist for PTSD, evidence-based psychotherapies, but very few Veterans receive them. Although VA has trained over 8,500 providers in evidence-based psychotherapies for PTSD over the past 10 years, only 6% of the 650,000 VHA patients with PTSD receive an evidence-based psychotherapy. It is critical that we connect Veterans with our most effective PTSD treatments and that we do so in a way that is Veteran-centered. Shared decision making is a patient-centered approach to choosing healthcare treatment options. It has been shown to increase patients’ motivation for treatment and ability to stay in treatment long enough to get benefit. It has also been shown to help providers align their practice with evidence-based guidelines. This proposal will refine and pilot test a shared decision making intervention for PTSD to be used in VA primary care clinics, where the vast majority of Veterans with PTSD are treated.
Project Better
The co-occurrence of posttraumatic stress disorder (PTSD) and hazardous drinking (HD) can be particularly devastating; though evidence-based treatments exist, many individuals with this co-occurrence drop out from or do not or cannot access specialty care. Text-messaging is a mode of intervention delivery that is low-cost, low-burden, and accessible to most people; development and testing of self-directed text message interventions that use evidence- and theoretically-based strategies to reduce PTSD and HD symptom burden is highly needed. Such interventions have the potential for great clinical significance via providing additional, novel treatment options that are readily scalable and have wide reach and thus can have a large impact on individual and public health.
The PREDICT study: a personalized medicine approach to prazosin for PTSD
Prazosin, like many of our most effective treatments for PTSD, seems to be significantly more effective for some individuals than others. We have hypothesized that this is because prazosin works to compensate for increased noradrenergic signaling, which is a primary driver of symptoms in some, but not all, individuals with PTSD. If we could identify individuals where increased or inappropriate noradrenergic signaling is driving PTSD symptoms, it would not only help us match individuals with treatments that will work well for them, but would also help us identify new treatment options.
The PREDICT study is a 5-year clinical trial designed to (1) test whether clinically-relevant biomarkers can predict in advance who is most likely to benefit from prazosin for PTSD; and (2) test a working model of how pre-synaptic and post-synaptic changes in the regulation of noradrenaline may combine together to produce the symptoms of PTSD.
The ATTEND study for Healthcare Workers and First Responders
Healthcare workers and first responders working during the COVID-19 pandemic have experienced increased exposure to suffering and loss; prolonged work hours; and increased personal risk. Although associated increases in psychiatric symptoms and occupational burnout are well documented, what aspects of the experiences are most strongly associated with negative outcomes over time – and what interventions are most likely to protect healthcare workers and first responders – are poorly understood.
The ATTEND study is designed to address the impact of occupational stress related to working during the COVID-19 pandemic on health care workers and first responders (police, fire, EMTs) through a national longitudinal survey paired with a local interventional clinical trial. The interventional clinical trial is designed to test the impact of treating sleep disruption with prazosin during or shortly after the period of exposure.
Communication and Recovery Enhancement (CARE) clinical trial
This study aims to refine and test a brief intervention (CARE) that aims to promote recovery in recent sexual assault survivors. CARE is delivered to supporters of sexual assault survivors (e.g., friends, family members, romantic partners), with or without the survivor present. It aims to encourage conversations about the assault and decrease negative reactions by the supporter. In stage 1 of this study, we will conduct feedback sessions with 8-10 dyads of survivors and their supporters to finalize the intervention materials. In stage 2, we will conduct a pilot clinical trial of CARE with 60 dyads, who will be randomized to dyadic intervention, supporter-only intervention, or waitlist control.
Project THRIVE pilot
This study involved developing and preliminarily testing a new app to prevent PTSD and alcohol misuse following recent sexual assault.
