With anxiety and depression on the rise amid the challenges of the COVID-19 pandemic, a West Virginia University-led study seeks to identify mental health issues and test online treatments among West Virginians at home - particularly those in rural areas, where access to clinical services is limited.
The Patient-Centered Outcomes Research Institute recently awarded an additional $500,000 in funding support to WVU researcher Robert Bossarte for a pandemic-related expansion of an existing project that compares treatment strategies for depressed patients in rural areas. The goal is to provide immediate relief for people with mild to moderate symptoms; anyone with serious symptoms will be referred for clinical treatment.
"These are really stressful times for people," said Bossarte, associate professor in the Department of Epidemiology with the School of Public Health and the Department of Behavioral Medicine and Psychiatry in the School of Medicine. "There's research coming out showing that there are pretty dramatic increases in new-onset anxiety, insomnia, depression. These are among people who had not previously been clinically diagnosed or had clinically meaningful symptoms.
"You couple the increase in symptoms with decreased access to clinical services, as clinical service lines consolidated to handle the influx in COVID-19 cases, and just the general fear about going to the doctor, and you end up in a situation where you could have a lot of people at home with symptoms that would benefit from treatment that are undetected and, therefore, not getting the help they need."
Expected to begin this month, the one-year expansion project involves inviting 100,000 West Virginians to complete a comprehensive online survey that assesses their symptoms as well as personal characteristics, history and preferences. Participants will be randomly assigned to different online treatment modules using a Harvard University-developed model, which accounts for any imbalances that could skew the results. Participants showing no signs of anxiety or depression will be assigned to a module focused on resilience and well-being.
Patients receive incentives for participating and incur no cost for treatment. Support is provided for 10 weeks to ensure each patient is progressing through the assigned treatment modules and identify lingering issues, such as insomnia, that might require additional treatment. The research team will assess patient progress at regular intervals over the course of three months.
"This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other stakeholders, but also for its potential to give people living in rural areas useful information to help them weigh the effectiveness of their treatment options for depression," PCORI Executive Director Nakela L. Cook said. "We look forward to following the study's progress and working with West Virginia University to share its results."
Bossarte previously received $13.3 million in funding support from PCORI in August 2018 for a seven-year study that aims to compare three treatment strategies for about 3,600 rural patients with depression, as diagnosed by clinical providers: antidepressants alone; antidepressants combined with unguided cognitive behavioral therapy provided online; and antidepressants combined with guided online cognitive behavioral therapy.
Bossarte and project partners across the country have spent much of the past two years designing the study and preparing the infrastructure, including the website used to survey participants and assign them to a treatment group. After a delay due to the pandemic, the research team is now prepared to begin accepting patients from two referring providers, but they expect a decrease in patient volume due to the pandemic. Bossarte said they are working with the U.S. Department of Veterans Affairs to identify supplemental participants who live in rural areas.
The first meaningful results are expected in about three months. Bossarte hopes the data generated by the study can be used to inform an algorithm that predicts which patients are likely to find success with online cognitive behavioral therapy. He said previous studies have focused on genotyping - rather than self-reported personal information - to see what treatment approaches are likely to work best.
"This work is really innovative," Bossarte said. "I'm really glad and proud we're able to do it in West Virginia. I think what makes us different from everything else that's going on out there is we're not just interested in knowing whether these platforms work. That's a question, of course, that we're interested in answering, but what we're really interested in is getting the best solution to each person as soon as possible."
PCORI is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that provides patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.
The WVU contract is being carried out in collaboration with the Depression and Bipolar Support Alliance of West Virginia and the Practice-Based Research Network of the West Virginia Clinical and Translational Science Institute.
PCORI's funding support was provided through WVU's Office of Sponsored Programs and the WVU Foundation, the nonprofit organization that receives and administers private donations on behalf of the University.