NCT05551195

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

A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women With Mild to Moderate Postpartum Depression

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Woebot Health · Industry
• Sex: Female
• Age: 22 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.

Detailed description

This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
DEVICE	WB001	WB001 is a digital therapeutic for postpartum depression.
DEVICE	ED001	ED001 is a digital therapeutic for postpartum depression.

Timeline

• Start date: 2022-11-16
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2022-09-22
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study