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

Stanford University

Status: Completed

Conditions: Cognitive Therapy; Depression, Postpartum; Depression; Telemedicine; Anxiety; Depressive Disorder; Mental Health

Treatments: Behavioral: Use of smartphone application (app); Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03646539

IRB-46467

Details and patient eligibility

About

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.

Full 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).

Enrollment: 201 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postpartum day 0-7 after delivery
• Medically stable and cleared for discharge
• Owns smartphone
• English-speaking (because all intervention materials are in English)

Exclusion criteria

• Neonatal demise this admission
• Intrauterine fetal demise this admission

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Smartphone use + treatment as usual

Experimental group

Description:

Participants will receive treatment as usual and use the smartphone app for the management of mood.

Treatment:

Other: Treatment as usual

Behavioral: Use of smartphone application (app)

Treatment as usual

Active Comparator group

Description:

Participants will receive treatment as usual.

Treatment:

Other: Treatment as usual