The Doctor Is Out: A Major Clinical Trial Is Testing Therapist-less Therapy in Rural America

At the beginning of his career, William Lewis, MD, rarely discussed mental health with his patients. But more than 20 years later, he screens for depression during every visit, and many more people are looking for help.

Lewis is a family medicine physician in Harper's Ferry, West Virginia, a state that has the highest rates of depression in the nation. About 30% of people living in the state have been diagnosed with major depressive disorder (MDD).

The study, which is underway in rural West Virginia and Kentucky, is testing internet-based cognitive-behavioral therapy administered through self-directed modules.

His team is examining whether the approach can improve mental health outcomes, as well as increase the willingness of primary care providers (PCPs) to refer these patients to the online therapy. He estimates he's spoken to about one third of his patients about the exploratory treatment for depression.

The Appalachia Mind Health Initiative (AMHI) trial has recruited more than 3300 people. When complete, it will provide experts with badly needed insight into what tools PCPs could use to expand access to mental health care.

The telehealth industry as a whole exploded during the pandemic and is projected to be worth more than $140 billion by 2030. Venture funding for digital-based health reached more than $14 billion in 2020, nearly twice the figure 2 years prior. The COVID-19 pandemic also pressured lawmakers and insurance companies to pay for telehealth.

Face-to-face teletherapy appointments became commonplace during that time. But internet-delivered cognitive-behavioral therapy (i-CBT) delivers the method through interactive websites or software. It does not require high-speed internet, is self-directed, does not require a therapist, and can be completed on a person's own schedule ― all benefits in rural areas without psychologists.

"If you have the right support, healthcare in rural areas is awesome. But if you have holes in your care network, this is one more way to reach people and reach them in real time," Lewis, who co-directs the WV Practice Based Research Network, told Medscape Medical News. Some of his patients have to wait months for a visit with a psychologist, he added.

Appalachia, and rural areas overall, provide ample opportunity for innovation in providing mental healthcare. A 2020 article published in Clinical and Translational Science estimated that as many as 65% of nonmetropolitan counties did not have a psychiatrist. Almost half ― 47% ― lack a psychologist, the investigators found.

As a result, PCPs like Lewis play an outsized role in helping patients access mental health care in rural areas.

Whether the self-guided tools work is a question that needs answering.

Previous randomized clinical trials have consistently shown that i-CBT tools can drastically reduce depression and anxiety in adults. But researchers are still testing which methods work best for people of varying demographics.

A Need With a Complicated Solution

The tool used in the trial, called SilverCloud, can run data from a participant's smartphone if they don't have internet access on other devices. The eight core modules are designed to mimic in-person CBT by teaching coping mechanisms, including different ways of thinking and understanding emotions. The depression modules each take an hour to complete. Additional segments cover topics such as grief, self-esteem, and sleep habits.

Within the trial, one group of patients has access to self-guided modules and "coaches" who are not therapists but have a bachelor's degree in behavioral health sciences. They review a person's responses to each module and provide written feedback that may suggest a person revisit a section of the module or recommend they next complete one of the additional segments on other topics.

A second group has access to the modules but not personalized feedback from coaches. They also do not have access to the additional modules.

A third group only takes antidepressants prescribed by their PCP and does not have access to SilverCloud. People in the three groups began taking antidepressants at the time of trial enrollment.

Participants who have received feedback and are guided toward tailored modules appear to have the best outcomes, according to Robert Bossarte, PhD, a professor in the Department of Psychiatry and Behavioral Neurosciences at the University of South Florida in Tampa, who is leading the trial.

He said the goal of the research isn't simply to test whether iCBT is effective but to understand how the tool is most effective, and for whom.

"The question is not, does it replace in-person care? It's, who will it benefit?" Bossarte said.

"It's not going to be a one-size-fits-all approach. As with any kind of precision medicine, we need to determine what works for which people, and in what form."

Some rural health experts question how much iCBT can improve mental health outcomes in areas where access to broadband internet is often a hurdle.

According to a study published in September in JAMA Open Network, about 20% or nearly 600 counties in the United States – an area with an estimated 10.5 million people ― have neither psychiatrists nor broadband internet. Broadband internet is quicker, does not limit data usage, allows for data-intensive activities such as streaming, and is the standard for much of the country.

"[i-CBT] may be helpful, but there are still obstacles," said Jan Probst, PhD, an associate director of the Rural and Minority Health Research Center at the University of South Carolina in Columbia, who is not involved with the trial.

Probst said online therapies such as i-CBT could improve quality of care, but they do not eliminate the need for rural PCPs who can diagnose depression and prescribe medication.

"Adjunctive is a keyword," Probst said. "The product assumes the availability of a practitioner who can make the depression diagnosis."

Getting PCPs on Board

Bossarte's original intent was to enlist the help of PCPs who would recruit their patients into the trial. That hope never came to fruition.

When interviewed before the trial began, many PCPs reported being excited about referring patients, Bossarte said. The trial launched at the beginning of the COVID-19 pandemic, and recruitment all but halted. Even after the pandemic had peaked, the trial was still getting few participant referrals from PCPs.

In early 2023, the investigators pivoted to using social media to target people in West Virginia and Kentucky.

After just 10 days, the campaign was so successful that the majority of the more than 3000 trial participants had signed up through social media. However, the trial still required that patients receive a documented diagnosis of major depressive disorder, which for most patients has been provided by their PCP.

"I'm not surprised that PCPs were aspirational to making referrals, but that this aspiration didn't play out in referral numbers," said Cory Cronin, PhD, director of the Appalachian Institute to Advance Health Equity Science at Ohio University in Athens, who is not involved with the AMHI trial.

Mental health is still not integrated into primary care, and clinicians may not ask whether a patient is struggling, Cronin said. PCPs across the nation are under extreme time constraints, which makes addressing every health problem a patient has challenging.

If a patient comes in for diabetes treatment, that usually becomes the focus of the visit, Cornin said.

Probst said getting physician buy-in is crucial, because social media can only reach certain demographics. By recruiting patients through social media, older patients may not be reached.

"They are pulling from a pool of people who are already inclined to do something like this," Probst said. "They aren't reaching the depressed 50-year-old who isn't tech savvy."

Bossarte said that to date, a little over a quarter of participants are older than 55, and 3% are older than 70. He added that some selection bias may result from participants who were recruited through social media because of their being comfortable with technology.

Probst said providing physicians with training in how to best incorporate trial recruitment into their patient flow is paramount. Rural areas have seldom been included in health research. West Virginia and Kentucky are among 23 states that receive targeted funding from the National Institutes of Health to create and support clinical trial capacity at medical institutions.

"It's hard for PCPs in these areas to sign people up because they've never been asked to do this before," Probst said. "You need to show them you are there to help them, not there to exploit."

Kaitlin Sullivan is a health, science, and environmental journalist.

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Images 1 & 2: University of South Florida

Image 3: Ohio University

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Cite this: The Doctor Is Out: A Major Clinical Trial Is Testing Therapist-less Therapy in Rural America - Medscape - Oct 10, 2023.