Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Smartphone use + treatment as usual
Participants will receive treatment as usual and use the smartphone app for the management of mood.
Intervention: Use of smartphone application (app) (Behavioral)
Treatment as usual
Participants will receive treatment as usual.
Intervention: Treatment as usual (Other)
Smartphone use + treatment as usual
Participants will receive treatment as usual and use the smartphone app for the management of mood.
Intervention: Treatment as usual (Other)
Outcomes
Primary Outcomes
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery
Time Frame: 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
Time Frame: 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 Outcomes
- Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 4 weeks post-delivery(Baseline; 4 weeks post-delivery)
- Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 4 weeks(Baseline; 4 weeks post-delivery)
- Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 2 weeks post-delivery(Baseline; 2 weeks post-delivery)
- Mean change from baseline in Edinburgh Postnatal Depression Scale Scores at 2 weeks(Baseline; 2 weeks post-delivery)
Investigators
Amy Judy
Clinical Assistant Professor
Stanford University