[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]

Inclusion Criteria

• •1. Must have primary residence in the United States
• •2. Must be ≤ 92 days postpartum
• •3. Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
• •4. Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
• •5. Participants must have current mild-moderate depression as measured by the HAMD-6 score \>7 and \<13 at screening
• •6. Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof
• •7. TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit