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

Not Applicable

Completed

• Conditions: Depression, Postpartum; Depression; Telemedicine; Cognitive Therapy; Anxiety; Depressive Disorder; Mental Health
• Interventions: Behavioral: Use of smartphone application (app); Other: Treatment as usual

• Registration Number: NCT03646539
• Lead Sponsor: Stanford University

Brief 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).

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Study Start: 2018-10-01
• Primary Completion: 2019-07-04
• Study Completion: 2019-07-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 201

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)

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Exclusion Criteria

• Neonatal demise this admission
• Intrauterine fetal demise this admission

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone use + treatment as usual	Use of smartphone application (app)	Participants will receive treatment as usual and use the smartphone app for the management of mood.
Smartphone use + treatment as usual	Treatment as usual	Participants will receive treatment as usual and use the smartphone app for the management of mood.
Treatment as usual	Treatment as usual	Participants will receive treatment as usual.

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery	Baseline; 6 weeks post-delivery	PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 6 weeks	Baseline; 6 weeks post-delivery	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \>9 is indicative of perinatal major depression.

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery	Baseline; 4 weeks post-delivery	PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks	Baseline; 4 weeks post-delivery	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \>9 is indicative of perinatal major depression.
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery	Baseline; 2 weeks post-delivery	PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks	Baseline; 2 weeks post-delivery	The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \>9 is indicative of perinatal major depression.

Trial Locations

Locations (1)

Stanford University Department of Obstetrics and Gynecology; 🇺🇸 Stanford, California, United States