Mental health platform enrolls first patient in postpartum depression clinical trial

The mental health platform Woebot Health has enrolled the first patient in a clinical trial evaluating a digital therapeutic for postpartum depression (PPD).

The trial will assess the safety and efficacy of WB001, a software as a medical device (SaMD) based cognitive behavioural therapy (CBT) programme for the treatment of mild to moderate PPD.

The multi-centre, double-blind, randomised controlled study is recruiting women ages 22 to 45 who have given birth in the last three months and are experiencing mild to moderate PPD.

Athena Robinson, chief clinical officer of Woebot Health, said: “Despite the significant prevalence of postpartum mood disruption after giving birth, women’s health care needs continue to be chronically underserved.

“Too many women are suffering in silence, and those who do seek support often struggle to access the resources they require.

“With WB001, our focus is to enable early interventions by making mental health care more accessible to mothers in their moment of need.”

The company says WB001 combines therapeutic alliance, human-centred design, machine learning techniques, CBT and interpersonal therapy (IPT) to treat PPD.

The solution is based on Woebot, a relational agent that enables guidance through the replication of some elements of human relationships.

WB001 was granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) in 2021 and, according to the developers, it would be the first digital therapeutic of its kind to be cleared by the FDA to date.

Around one in seven women can develop postpartum depression (PPD), most commonly within the first six weeks after childbirth.

While women experiencing baby blues tend to recover quickly, PPD tends to last longer and severely affects women’s ability to return to normal function.

“Unlocking this therapeutic effectiveness has the potential to improve both the quality and the scalability of mental health care, providing support to patients on waiting lists and in between clinical encounters,” said Robbert Zusterzeel, Woebot Health vice president of regulatory science and strategy.

“The real world evidence generated by this study will provide us with data to understand the impact of WB001 adjunctively to women’s usual treatment, including pharmacotherapy and psychotherapy.

“We look forward to sharing our progress as we continue to evaluate its efficacy.”