Randomized Clinical Trial of an Automated Conversational Agent Versus Treatment as Usual for the Management of Perinatal Mood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum day 0-7 after delivery
- •Medically stable and cleared for discharge
- •Owns smartphone
- •English-speaking (because all intervention materials are in English)
排除标准
- •Neonatal demise this admission
- •Intrauterine fetal demise this admission
结局指标
主要结局
Mean change from baseline in Patient Health Questionnaire (PHQ-9) scores at 6 weeks post-delivery
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Amy Judy
Clinical Assistant Professor
Stanford University