NCT04576754

Pivotal Test: WB001

Postpartum Depression Pivotal Test: Randomized Clinical Trial of WB001

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Woebot Health · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present randomized controlled study is to investigate if there is a difference in postpartum depression symptoms among participants assigned to : 1. an automated conversational agent based on the most researched and scientifically validated psychotherapies, primarily Cognitive Behavioral Therapy (CBT), and accessible via an iOS and Android application, or to 2. a comparison condition without CBT and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
DEVICE	WB001	The WB001 treatment consists of PPD-specific psychoeducational lessons and CBT-specific skills or tools. The lessons teach PPD-specific information to normalize and contextualize postpartum experiences, as well as provide information on effective mood management and mental health promotion in the context of having recently given birth. Patients complete up to 30 psychoeducational lessons. In addition, patients access and apply core CBT-based tools upon endorsing a negative mood. These tools are core to CBT and are considered transdiagnostic. Examples include thought challenging, behavioral activation, mindfulness, and self-care.
DEVICE	Educational	The Comparison Condition provides educational only material about various mental and physical topics, delivered in an interactive smartphone application that is accessible anytime of day.

Timeline

• Start date: 2020-11-12
• Primary completion: 2021-06-14
• Completion: 2021-08-20
• First posted: 2020-10-06
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States