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

Study Overview
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Brief Summary
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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
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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).

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

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

Intervention / Treatment
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* Behavioral: Use of smartphone application (app)
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone use + treatment as usual<br>Participants will receive treatment as usual and use the smartphone app for the management of mood. | Behavioral: Use of smartphone application (app)<br>* Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.<br>Other: Treatment as usual<br>* 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.<br>|
| Active Comparator: Treatment as usual<br>Participants will receive treatment as usual. | Other: Treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 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. | Baseline; 6 weeks post-delivery | 
| Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 6 weeks | 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. | Baseline; 6 weeks post-delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 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. | Baseline; 2 weeks post-delivery | 
| Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 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. | Baseline; 4 weeks post-delivery | 
| Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks | 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. | Baseline; 2 weeks post-delivery | 
| Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks | 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. | Baseline; 4 weeks post-delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Automated conversational agent