Woebot Heath has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its digital therapeutic to treat postpartum depression (PPD).

WB001 is an investigational digital therapeutic that integrates cognitive-behavioural therapy (CBT) and elements of interpersonal psychotherapy (IPT) with a deep understanding of the lived experience of PPD to minimise symptoms of depression.

Woebot’s digital therapeutic, which is a prescription-only treatment, is provided over eight weeks through a patient’s smartphone.

Designed to use under the supervision of a clinician, the digital therapeutic features the firm’s advanced relational agent Woebot.

In a recent study, the relational agent was demonstrated to have a capability to form a bond with patients to facilitate meaningful engagement and improved outcomes.

Woebot is part of the company’s AI-powered platform that offers the foundation for the development of digital therapeutics and tools, the company said.

As per the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, PPD is a major depressive episode with symptom onset during pregnancy or within four weeks of delivery.

Woebot Health chief clinical officer Dr Athena Robinson said: “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.

“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.”

WB001 has been designed to enhance patient motivation and treatment efficacy in a noninvasive way, said the company.