As 2020 Closes, Researchers Reflect on Uncertainty and Opportunity

NIH

After years of working out technical details, consulting with focus groups, and conducting promising pilot studies, Duke University Assistant Professor Roger Vilardaga, Ph.D., was ready to test his mobile app Learn to Quit—a smoking cessation tool designed specifically for people with serious mental illness. In early March, he received welcome news: The National Institute on Drug Abuse (NIDA) would fund his proposed multisite clinical trial of the app.

A few days later, in response to the emerging COVID-19 outbreak, North Carolina declared a state of emergency, the Duke campus shut down, and Vilardaga’s study came to a screeching halt. As he told Psychiatric News, that week proved to be an emotional roller coaster.

Vilardaga’s experience was echoed thousands of times over across the country, as investigators in mental health and other disciplines were forced to postpone or even abandon their research projects in the wake of a novel coronavirus and the dramatic early measures to slow its transmission.

“The past several months has been challenging for everyone in research,” said Susan Weiss, Ph.D., director of the Division of Extramural Research at NIDA. On the funding side, NIDA and its fellow institutes have been allocating their limited resources between providing extensions or amendments for existing projects impacted by the pandemic and supporting important new initiatives exploring COVID-19’s impact on mental health.

“We don’t have enough money to make every impacted researcher whole again,” she said. “We try to ensure that the most vulnerable grantees, especially new investigators, receive support. But some investigators’ projects just had to stop.”

With challenges come opportunities, and mental health researchers are finding ways to adapt to and solider on in these uncertain times.

“This past year has been tough on research, but I have also seen tremendous resilience among our research community,” noted George Koob, Ph.D., Director of the National institute of Alcoholism and Alcohol Abuse. “Like everyone, I’m hopeful the situation will soon resolve, but this pandemic has made us all a little more efficient and creative.”

Researchers Adapt to Remote Research

Studies requiring psychological or cognitive evaluation of patients with mental illness may be able to adapt to physical distancing restrictions now in place, but researchers have faced hurdle after hurdle in the nine months since the pandemic emerged in the United States.

“Our group was in a better situation than [others] since we were already working with digital health and remote monitoring,” noted Zev Schuman-Olivier, M.D., the director of the Center for Mindfulness and Compassion and medical director for Addiction Services at Cambridge Health Alliance (CHA), a Harvard-affiliated safety-net health system in the greater Boston area.

In addition, Philip Wang, M.D., Dr.Ph., CHA’s chief of psychiatry, had conducted studies on how Hurricane Katrina had impacted mental health care. “Katrina, as well as the 2016 Baton Rouge flood, were localized events, but they both highlighted how a disaster both exacerbates the need for mental health services while disrupting the paths to receive these services,” Schuman-Olivier said.

As a result, in the earliest days of COVID-19, CHA was aggressive in expanding its telemental health capacity. This enabled Schuman-Olivier to shift his new projects toward online screenings and online mindfulness interventions.

“We were able to develop a remote presence quickly, but it made life very complicated,” Schuman-Olivier acknowledged. There were issues like replicating a quiet, distraction-free environment needed for neuropsychological tests and finding a secure way to collect remote data.

“Our researchers were at home too, and they couldn’t just keep patient data on their personal hard drive,” he said. Collecting specimens for studies involving patients with substance use disorders also became more complicated, as routine in-person visits had to be replaced with observed oral fluid collection via videoconference. The center had to make plans to collect salivary samples with deliveries and pick-ups of specimen kits packed in dry ice.

But while modifying a newly funded project could be cumbersome, the studies already going full steam proved to be bigger problems, Schuman-Olivier said. For instance, he was overseeing a study involving a stress intervention at multiple primary care sites that was about 75% complete. “When COVID-19 hit, all of our participants became overwhelmed with stress and anxiety, and our data just completely blew up,” he said. “Primary care as we knew it also disappeared, and many staff were assigned to inpatient COVID units, so the study had to end prematurely.” For another study that required periodic brain scans, one entire cohort of participants missed their designated window because the imaging facility was shut down.

Weiss understands the impact of brain imaging disruptions all too well, as part of her portfolio involves the ABCD Study. This multi-institute effort is assessing nearly 12,000 children with periodic questionnaires and brain scans over a decade to better understand human brain development. “ABCD started so strong; we exceeded our recruitment goal and had a great retention rate. When everything started shutting down in March, it was concerning,” she said.

It took some scrambling, but NIDA worked with the ABCD investigators across the country to make almost all the behavioral and cognitive assessments virtual, though some imaging data could not be completed. “Losing some data is always difficult, but at the same time, we now have a chance to study the short- and long-term effects of COVID on the well-being of thousands of families,” she said, noting that the study now includes specific assessments related to the pandemic.

New Projects Examine Effects of Pandemic

NIDA has not been alone in looking for ways to leverage scientific resources to better understand how this pandemic is affecting mental health and substance use. At the National Institute of Mental Health (NIMH), the Dimensional Traumatic Stress Research Program has been on the forefront in coordinating the institute’s postpandemic response.

“In every major disaster over the past 40 years, researchers have mobilized quickly to understand and try to mitigate the mental health impact,” said program director Susan Borja, Ph.D. “They know which tools to bring and what questions to ask in various scenarios, and they take on the challenge even though it is unexpected extra work.”

Borja added that several investigators funded by her program were familiar with what to expect with a virus outbreak, given the far smaller but still consequential SARS outbreak that occurred in 2003.

“Looking back at [the] SARS [outbreak in 2003], we knew that a coronavirus outbreak would lead to disruptions in medical care and supply chains in the short term, while paving the way for long-term mental health risks,” she said. “What we did not know early on was how deadly and how fast this virus would spread. Looking at ways to extend our limited mental health resources through technology is a current focus of our program.”

Several projects to meet this goal have recently launched. Gregory Simon, M.D., M.P.H., a senior investigator at the Kaiser Permanente Washington Health Research Institute, is examining how the rapid shift from office-based to virtual psychiatric therapy has affected patients’ illness severity and quality of care. Patricia Arean, Ph.D., a professor of psychiatry at the University of Washington, is testing several mobile apps that may help reduce suicide risk in essential workers and other high-risk groups.

Creativity, Resiliency Will Likely Benefit Research

Though it took months, Vilardaga has managed to adapt his protocol for his large clinical study to be fully virtual in recruitment and follow-up. As with some of Schuman-Olivier’s projects, a big obstacle was how to incorporate virtual biochemical verification of smoking abstinence. (His team will send periodic in-home breath tests and have participants take the tests on video calls to ensure accuracy). The new protocol will also include questions related to COVID-19 to assess how this pandemic has affected smoking habits and overall well-being of people with serious mental illness (SMI).

is experiences during this time have made him appreciate people involved with carrying out a clinical trial. “It’s not just that we can’t see patients,” he said. “I had staff who needed time off to help take care of children, and I couldn’t hire new staff for a while since the campus shutdown included a hiring freeze.” The reduced personnel capacity also slowed the pace of the institutional review board that oversees his trial and approves every addition or amendment to his protocol.

Despite these challenges, Vilardaga remains positive. “So far, NIDA and the National Cancer Institute (which funds some of his smoking research) have been very understanding, and even with the delays, I still hope to start early next year,” he said. He is also cautiously optimistic that the change to a virtual study will boost recruitment. “There are barriers to retaining people with SMI in traditional trials requiring in-person visits; if people can participate from their own homes, they may be more engaged.”

“We cannot forget how this pandemic has also brought health disparities, particularly for racial and ethnic minorities, to light,” Borja added. “As we think about digital tools, we want to ensure we are reaching the most vulnerable people right now and that includes addressing a digital divide in access and use.” ■