NCT05662605

W-PPMA for Postpartum Mothers

A Randomized Controlled Trial of the Feasibility and Acceptability of W-PPMA for Postpartum Mothers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Woebot Health · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

To evaluate the feasibility and acceptability of W-PPMA among a diverse group of postpartum mothers.

Detailed description

This randomized waitlist-controlled trial evaluates the feasibility and acceptability of the W-PPMA digital health tool. Participants will be recruited from the IRB-approved PowerMom research study of Scripps Research and, if interested, will complete screening for the sub-study. Eligible participants will be asked to provide informed consent and complete the baseline assessments. Those that do not meet eligibility criteria may resume their PowerMom experience. Eligible participants will be randomized to one of two groups, W-PPMA or Waitlist, and will receive instructions on when and how they can access the digital health tool. Primary endpoints will be measured at 8-weeks (end of treatment) with additional measures being collected at 1- 4-, 8-, 12-, and 16-weeks (end of study). Screening, consenting, and outcome measures will be completed online through the MyDataHelps app.

Conditions

• Postpartum Period

Interventions

Type	Name	Description
DEVICE	W-PPMA	W-PPMA is a digital health tool designed specifically for the postpartum experience and is accessed through a mobile application which delivers evidence-based therapy through brief "conversations" with a fully automated relational agent called Woebot.

Timeline

• Start date: 2023-02-22
• Primary completion: 2024-01-18
• Completion: 2024-03-17
• First posted: 2022-12-22
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States