Sometimes legends walk among us. We would be wise to pay attention.

Dr. Aaron Beck, regarded as the father of modern cognitive behavioral therapy (CBT), passed away last month, soon after celebrating his 100th birthday. Dr. Beck’s historic life compels us to examine his pioneering work in furthering behavioral medicine and the need to extend that work to the current state of mental health treatment. What can we learn from Dr. Beck’s approach to generating evidence for the effectiveness of CBT to establish a similar model of scientific discipline for newer modalities like digital therapeutics (DTx)? How would doing so enable effective, consistent, scalable solutions for mental health conditions to meet the soaring modern-day demand for mental healthcare?

Dr. Beck’s genius was to apply standards in medicine such as randomized controlled trials (RCT) and quantifiable indices of patient recovery to psychotherapy research, developing practices that validated the efficacy of evidence-based CBT for mental health conditions. Other clinical psychological scientists followed suit, and over the years, dozens of studies of CBT have supported its effectiveness for a range of psychological conditions, including depression, generalized anxiety, post-traumatic stress disorder, obsessive-compulsive disorder, substance use disorders and borderline personality disorder.

The replicability of evidence supporting its effectiveness earned CBT the confidence of medical practitioners, patients, insurers, government agencies and employers, all of which has led to its establishment as a first-line mental health treatment. For decades, pharmaceutical companies have used the same approach to establish the credibility of psychotropic drugs, determined largely on the basis of replicable RCT evidence. It’s clear that rigorous RCTs – in which the highest levels of evidence result from appropriate study design and proper analytical techniques that minimize bias in outcomes – are the gold standard of research and therapeutic legitimacy.

However, despite Dr. Beck’s groundbreaking career, he could not have solved our current mental health crisis. In-person CBT’s structural and logistical limitations and high cost can’t fully address the growing mental health need, compounding inequities in access to care: Thirty-seven percent of the U.S. population, 122 million people, live in areas experiencing mental health professional shortages. Even when individuals have access to a therapist, they do not always receive evidence-based care. Scaling the supply of providers in the short term and even long term is unrealistic. And in most areas of the country, the cost of therapy averages $100 to $200 per visit, beyond the budget of most people needing care. In addition to logistics and cost issues, the societal stigma surrounding mental health problems and help-seeking are felt most acutely by marginalized populations (e.g., Black, Latinx, LGBTQ+ and disabled communities) and can inhibit individuals from engaging in traditional therapy.

Psychiatric medications, the most commonly provided mental health treatments, are highly scalable, but the presence of side effects, the potential for dependence and minimal long-term benefits for some drugs limit their ability to address the ballooning need and root causes of mental health conditions. In fact, 82% of patients being treated for mental health receive medications. Additional research has shown that more than half of people using selective serotonin reuptake inhibitors (SSRIs) may experience moderately severe adverse events within two weeks of treatment. Benzodiazepines and hypnotics, commonly prescribed for anxiety and sleep disorders, have the strongest FDA black-box warnings due to their potential safety risks.

Even when medications are prescribed, studies show that harmful racial biases can interfere with prescribing patterns. Black and Hispanic individuals are more likely to have their benzodiazepine prescriptions, a common class of anxiety medication that includes Xanax, discontinued even when no indications of misuse existed. Further, a majority of people of color surveyed in one study reported experiencing microaggressions in psychotherapy. These alarming practices severely limit treatment options for people of color.

The sum of these factors shows that currently established CBT and pharmaceutical approaches have resulted in too few people having access to the most effective, evidence-based care.

While Dr. Beck’s studies were the product of a pre-digital world, technological advances in medicine are increasingly migrating to mental health treatment, including DTx — clinically evaluated software that delivers significant health outcomes and can be provided alongside medications. DTx’s attributes for scalability, access, destigmatization and affordability can help close the mental healthcare gap, facilitating greater equity and saving millions of people from suffering in silence.

However, to fulfill that promise, the proven model of replicability established by Dr. Beck must be adopted by the DTx industry, with RCTs directly testing its unique, digital modality of intervention. Relying on the replicability of in-person CBT is not enough to establish that digital CBT is now leading to significant, sustainable improvements in mental health.

Conducting and publishing rigorous, replicable research is the approach that must become the norm within the DTx industry if it is to truly become a legitimate option alongside in-person CBT and medications. Unfortunately, many in DTx have not done enough to adhere to the RCT gold standard. In any other medical practice, if you create a new model, you have to publish gold standard clinical research and prove significant clinical outcomes. We in DTx must do the same, focusing on producing modality-specific evidence for consistency in outcomes. Individual companies that don’t embrace this approach will be left behind, but the consequences will also damage DTx by harming its growing reputation and undermining the potential to offer scalable, effective solutions for the growing mental healthcare need.

I’m lucky to have witnessed the last chapters of Dr. Beck’s remarkable life. Without his work, mental health treatment would not have been able to help so many people. But, in the same breath, I’ll issue a challenge: Who is prepared to step up and be the Aaron Beck for DTx? Before the next 100 years are over, who will be recognized as the mother or father or digital therapeutics? Will it be me? Will it be you?

Juliette McClendon is a clinical psychologist with expertise in the research and treatment of mood, anxiety and personality disorders. She is a nationally known expert on racial and ethnic health disparities and has worked extensively to address the impact of stress and trauma on the mental and physical health of people of color. Prior to joining Big Health, McClendon served as an assistant professor of psychiatry at Boston University School of Medicine and a psychologist at the National Center for PTSD in the Women’s Health Sciences Division of the Veteran’s Affairs (VA) Boston Healthcare System.

In 2020, McClendon was honored as a Health Disparities Research Institute Scholar by the National Institutes of Health (NIH). McClendon holds an undergraduate degree in psychology from Harvard University and a master’s and PhD from Washington University in St. Louis in clinical psychology, with a focus on racial and ethnic health disparities.

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By seohan