Digital mental health company Woebot Health has landed FDA Breakthrough Device Designation for its postpartum depression digital therapeutic, WB001.

WB001 combines cognitive behavioral therapy and elements of interpersonal psychotherapy with the company’s conversational chatbot, Woebot, to deliver treatment directly through patients’ phones.

Designed as a prescription digital therapeutic, the eight-week program treats symptoms of postpartum depression through lessons that attempt to normalize and contextualize the postpartum experience.

Specifically, the CBT-based tools help users adjust their behavioral practices through mindfulness and self-care, while the IPT-based tools focus on relationship transitions, communication analysis and skill-building.

The FDA Breakthrough Device Designation aims to give patients access to technologies that have the potential to provide treatment or diagnosis for debilitating diseases or conditions while giving Woebot support throughout the premarket review phase.

WHY THIS MATTERS

Postpartum depression differs from the more common “baby blues” that between 50% and 75% of mothers experience after giving birth, according to the Cleveland Clinic. Whereas the “baby blues” typically subside after a few weeks without treatment, postpartum depression can last up to a year.

Common symptoms of postpartum depression are frequent crying, irritability, fatigue, as well as feelings of guilt, anxiety and the inability to care for your baby or yourself. Roughly one in 10 mothers experiences postpartum depression, according to the Cleveland Clinic.

Despite the prevalence and associated risks of postpartum depression, a significant portion of mothers never receive diagnosis or treatment for the condition, according to a report in The Journal of Perinatal Education.  .

In the US, most new mothers are discharged from the hospital two days after childbirth and oftentimes don’t see a healthcare professional for a follow-up for six weeks. Even when they are seen for their six-week checkup, “the visit tends to focus on the physical aspects of care, including breastfeeding and birth control options, and emotional or coping needs are rarely met,” the report says.

“The odds are truly stacked against women who are hit with barriers to treatment right after childbirth, especially those of lower socioeconomic status and/or minority populations who are at a higher risk for PPD but face ongoing and concerning care disparities that pervade the mental healthcare system,” Dr. Athena Robinson, the chief clinical officer at Woebot Health, said in a statement.

“WB001 is designed to significantly reduce barriers to PPD care that often thwart help-seeking and treatment engagement behaviors – including lack of time, childcare issues, stigma and fear of loss of parental rights. We’re proud to be offering a scalable, clinically validated digital treatment for such a pervasive, serious and heartbreaking condition.”

THE LARGER TREND

Woebot debuted in 2017 as an app for Facebook Messenger that would engage users in discussions of anxiety or depression. It scored $8 million the following year after launching its standalone app.

The company’s automated conversational agent was recently included in a study that revealed it can form similar bonds with users as real-life therapists.

Several other digital health companies have turned their focus to maternal health outcomes. In 2017, Massachusetts General Hospital created a free app to help screen and diagnose mothers with postpartum depression.

Following its acquisition of myStrength, Livongo beefed up its behavioral health offerings to include the range of experiences that can come with pregnancy and early parenthood. The companies have since been absorbed by Teladoc Health.

Last year, Hoag Memorial Hospital Presbyterian and BehaVR teamed up to offer moms-to-be NurtureVR, a virtual reality program that supplies prenatal education, pain management, mindfulness strategies and support after giving birth.

Also last year, hybrid maternal-health startup Oula launched with $3.2 million in seed funding.