“Psychiatry is a field with high unmet needs. Patients want to listen to the doctor’s explanation more, and doctors also want to provide quality counseling continually. Currently, drugs are the primary means of mental health treatment because of low counseling reimbursement rates and the shortage of counseling time. But if we utilize digital technology, we can provide more effective treatments.”
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So said Seok Jeong-ho, a professor of the Psychiatry Department of Yonsei University Gangnam Severance Hospital, explaining why he was willing to develop a digital therapy during an interview with Korea Biomedical Review.
Seok serves as CEO of Minds AI, a company within a university laboratory, to develop digital therapeutics and hopes to provide universal mental health counseling and treatment for Korean patients.
“There is still misunderstanding and prejudice against visiting a psychiatrist or getting mental health treatment in Korean society. This is a stumbling block for patients who need treatment and counseling before progressing to severe depression,” Seok said. “Contactless consultation and counseling will solve this problem, at least partially.”
Minds AI is developing and operating Minds.NAVI, a mental health analysis evaluation program, and CHEEU.Forest, a mental health virtual reality (VR) assessment/education/training program.
In November, the company obtained the regulatory approval for an exploratory clinical trial to evaluate Minds.NAVI’s efficacy and safety.
In the trial, the research team will form three cohort groups — a healthy control group, a group of depressed patients who do not require medication, and patients suffering from a major depressive disorder. Then, the research team will conduct a psychological test, a blood test, and a saliva test to establish the basis for evaluating the stress index.
Seok plans to enroll about 100 patients and complete the exploratory trial in the first half of next year.
Minds AI is working on CHEEU.Forest to help patients overcome childhood trauma, control suicidal thoughts, and train to be considerate through VR with a psychological counselor.
The product is offered as a kiosk at the hospital’s psychological counseling center but will be developed as a mobile form in the future.
Seok also plans to combine digital technology with AI to raise the diagnostic accuracy of depression.
“Each doctor diagnoses the severity of depression differently,” he noted.
Suppose he can accumulate hematological and psychological indicators of depressed patients such as heart rate variables, neuro-inflammation markers, blood levels, and psychological counseling results. In that case, he will make an auxiliary diagnostic kit to measure the suicide risk of depression, he explained.
Even if digital therapeutics allows remote psychological testing, education, and training, they should not exclude the intervention of counselors or specialists, Seok argued.
Some developers are working on application-based electronic antidepressants that do not involve human intervention. These apps might be easy to distribute broadly, but not many people with depression can train using the app by themselves consistently, he said.
“They must get someone’s help.”
Digital therapeutics for depression should be run along with active management programs, Seok went on to say.
“Patients should not be left alone to do everything by themselves. We need safeguards against suicidal crises, such as when a patient suddenly develops suicidal thoughts while using digital treatment,” he said. “This is why a psychiatrist must participate in the development of a digital treatment for mental health.”
He expressed regret over the government’s review process regarding digital therapeutics.
He said that the government has a poor coordination process for medical device approval review, classification and assessment of new health technologies, and approval review for innovative medical devices.
“There is a lack of connection between departments within a government agency,” he said.
Also, he said that the Ministry of Food and Drug Safety, the Health Insurance Review and Assessment Service, and the National Evidence-based Healthcare Collaborating Agency are not collaborating organically.
Digital therapeutics could cause issues of personal information leakage, requiring an establishment of information protection technology simultaneously, Seok said.
Additionally, he said the government should make a proper reimbursement system to expand the digital therapeutics market.