Woebot Heath recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s digital therapeutic for the treatment of postpartum depression (PPD). That means the company can work with FDA through an expedited process during various phases of the product’s development and, ultimately, its broader availability.

Time is of the essence with this condition. As many as 20 percent of women who have given birth experience PPD which, when left untreated, can present immediate and long term risk to the mother and infant. Despite the prevalence and risks of PPD, almost 60 percent of women who experience PPD symptoms do not receive a clinical diagnosis. Among those who do screen positive for the condition, less than 25 percent receive follow up care.

We’re talking to Chief Clinical Officer Athena Robinson about the condition, how it affects women, and what a breakthrough designation means for the first digital therapeutic for PPD.

What was the impetus for creating this product?

Women are integral to our families and our communities, yet they have often been ignored in their mental health journey during the postpartum phase. To me, this product is an opportunity to help those who have struggled, often in silence, with all the nuances of becoming a mother. They face so much stigma, yet their responsibility for feeding, caring for and nurturing children is significant. I can say this as a mother myself; we care for our children with open arms and tons of love in our heart, but let’s be honest, it’s really hard. There’s something really powerful here about acknowledging the health of women.

What’s it like to have postpartum depression?

By definition, depression impacts core aspects of a person’s functioning, and it’s the same as when it occurs in postpartum depression. The difference here is that it’s a super critical period for both mother and baby. If you think about those early months when you bring a new baby home, there is so much rapid physical and emotional development for the infant. The mother is going through a host of lifestyle, schedule, physical and emotional adjustments as well. Depression works by removing hope, energy, concentration capability, and pleasure, and it often reduces the ability for mothers to feel connected or bonded with their baby.

That sounds incredibly challenging.

Imagine that experience all within the context of this precious period and you can really start to see how much of a weight this is on parents’ shoulders. Women often talk about feeling chronically overwhelmed, full of self doubt, exhausted beyond belief and hopeless that there’s no end in sight to these sorts of things.

What does WB001 do?

It’s an investigational digital therapeutic designed to reduce depression that’s delivered over 8 weeks and combines cognitive behavioral therapy (CBT) and elements of interpersonal psychotherapy (IPT) with a deep understanding of people’s lived experience.It gives women real time access to mood management tools that can help them reduce the impact of feeling overwhelmed, figure out how to get more social support, and improve their overall self-efficacy to manage their condition. 

You did a lot of research to develop this product, including talking to women with lived experience. Was there a particular story you remember?

One woman was very gracious and open with her story. She had developed postpartum depression with her second child, not with her first. She talked about how the baby was often crying and she felt so depressed and so disconnected that it was hard for her to be motivated to nurture the baby. On top of that, she was aware of this disconnect, and so she also felt an acute, additional layer of guilt. It was a double whammy. The way she described it was so true to her experience and deeply moving. She was desperate to be out of that situation. That struck me because these women understand the situation and the impact, and they live with it. They want to feel connected with their babies and they want to feel hopeful. 

There are currently treatment options for women, but they are few, and have their own complications. Why does this one stand out?

In the early months after having given birth, time is wonky. You’re trying to figure out your schedule, and your baby is trying to figure out their schedule. It’s often hard to get in a shower, or go to the grocery store, or just do all the things you need to do when you have an infant who always needs you. We wanted to make something that minimizes the burden to get help, overrides stigmas as a barrier, and is instantly accessible, so there’s no need to arrange childcare or navigate multiple channels within the healthcare ecosystem to get help. That’s the beauty of a digital therapeutic. It’s there when you need it. We know from our existing users how much that matters. About 78% of Woebot’s conversations happen outside of clinical hours, and 60% happen during the night, between 10:00 PM and 5:00 AM. 

This is such a huge problem. Why has it taken so long to develop a digital therapeutic for PPD?

Postpartum depression isn’t new in 2021. But there have been decades of not having mental illness and mental health conversations. We’re seeing the consequences of that. And now we’re trying to overcome it. There’s a new energy that’s behind overcoming stigma, and new technology to work on a solution. This is really a breakthrough moment.

Is WB001 the first digital therapeutic for PPD?

It is. What’s great about the breakthrough designation is it allows us to engage with FDA more frequently. FDA designed the breakthrough program to liaise with manufacturers so they can get needed products to patients more swiftly. FDA are scientists at heart, but they also want what’s in the best interest of the patient. Now we can work together as thoughtfully and with as much scientific rigor as we can, but also as soon as we can.

You just issued a study that indicates Woebot is able to form a bond with users. Why is that significant in the context of postpartum depression?

Social support is a construct that has long been studied in psychological research and discussed in therapy rooms. This notion of being able to have a relational agent or a guided self-help coach that you can build a bond with that gives you that sense of social support is so important in the experience of postpartum depression. Providers who have worked with postpartum depression have universally shared with me how important it is for this group of women to feel supported and connected and cared for. And since we have a relational agent that can facilitate that bond, then it’s really a nice fit, like two puzzle pieces coming together for the very clinically-based needs these women may experience.