NCT03646539

RCT of Automated Conversational Agent vs. Treatment as Usual for the Management of Perinatal Mood

Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the efficacy of an evidence-based smartphone application (app) for the management of mood compared to treatment as usual alone among 135 women who have been discharged post-delivery from Labor and Delivery at Stanford Children's Health - Lucile Packard Children's Hospital. Using psychometrically validated surveys for depression, postpartum depression, and anxiety, this study will evaluate whether the smartphone app has a differential effect on the mental health of postpartum women as compared to treatment as usual.

Detailed description

The intervention is a cognitive behavioral therapy (CBT) based automated conversational agent available as a mobile device smartphone application. When a user logs in with the app, it asks questions about that user, such as how they're feeling, and the user is able to type their response, similar to texting or messaging. The app is then available for use by the user anytime (24 hours per day 7 days per week), and will check in with the user to encourage mood tracking followed by tailored delivery of CBT-based tools and other general psychoeducation. This smartphone app interacts with conversational tones, and offers empathy and behavioral pattern insight to users. The app's artificial intelligence becomes more specific to a user over time, based on conversations. The app allows patients are able to immediately process and receive empathy for significant events and removes barriers traditionally limiting treatment access (cost, stigma, health care system navigability, and lack of childcare or transportation).

Conditions

• Cognitive Therapy
• Depression, Postpartum
• Mental Health
• Depression
• Depressive Disorder
• Anxiety
• Telemedicine

Interventions

Type	Name	Description
BEHAVIORAL	Use of smartphone application (app)	Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.
OTHER	Treatment as usual	Treatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-07-04
• Completion: 2019-07-04
• First posted: 2018-08-24
• Last updated: 2020-09-21

Locations

1 site across 1 country: United States