The University of North Carolina is tapping Google's Verily Life Sciences and MindStrong (the company for which Dr. Thomas Insell recently left Verily) for an ambitious 19-site study of post-traumatic stress disorder. The study, called the Aurora Study, is funded by a $21 million NIH grant and aims to enroll 5,000 people.
Aurora was launched last September and has sought private funding to supplement the NIH grant. It's just now bringing on partners however, and just now beginning to recruit participants.
"Although many people have heard of post-traumatic conditions such as postraumatic stress (PTS), post-concussion syndrome, and depression, the onset and progression of these disorders remain poorly understood," Verily Mental Health Data Lead Menachem Fromer and Dr. Sam McLean, director of the Institute for Trauma Recovery at University of North Carolina, wrote in a blog post on Verily's website. "Biomarkers to identify people at high risk or to diagnose those with one or more of these outcomes do not exist. Treatment options are limited. These critical gaps in scientific knowledge prevent health care providers from proactively identifying and effectively treating civilian trauma survivors, service men and women, and combat veterans with these common post-traumatic conditions."
Participants will be recruited into the trial when they show up at one of UNC's partner institutions to be treated after a traumatic event. By studying a large group of trauma survivors and noting which ones develop PTSD, researchers can get a better idea of how the disease develops. Participants will be monitored via Verily's Study Watch wearable, smartphone apps, and other more traditional assessments.
"Typically in research, diseases or conditions are assessed at a single moment in time — yet a clearer picture of health conditions may be better obtained by the evaluation of numerous variables over time," Fromer and McLean wrote. "Using continuous physiologic data obtained from the Study Watch, Aurora study investigators will determine whether it is possible to identify individuals at-risk for persistent post-traumatic sequelae, as well as to diagnose and predict symptom progression. In addition, investigators will examine other passive data collection methods using smartphone apps, as well as in-person visits, genomic measurements, neurocognitive tests, patient surveys, and medical record reviews. These will be brought together to build a broad landscape of the disorder."
that MindStrong will also be involved in the study, using its "digital phenotype" assessment technology to measure processing speed, attention, memory and executive function based on a participant's interaction with their smartphone.
In addition to studying PTSD, the novel data collection methods are also being studied, allowing Verily and MindStrong to tweak, assess and validate their research protocols before using them in even larger endeavors like the Baseline Study.
"Building a research framework for rich data collection is the first step to diving deeper into conditions that have been traditionally hard to study due to their multifactorial etiology, including post-traumatic conditions," Fromer and McLean wrote. "We believe this study could serve as a model for collecting and synchronizing multidimensional datasets that touch the full lives of participants and has the potential to be transformative for mental / brain health research and care. We look forward to getting started."