NCT04576754已完成不适用
Postpartum Depression Pivotal Test: Randomized Clinical Trial of WB001
Woebot Health2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Hamilton Depression Rating Scale for Depression (HAMD)
研究概览
简要总结
The purpose of the present randomized controlled study is to investigate if there is a difference in postpartum depression symptoms among participants assigned to :
- an automated conversational agent based on the most researched and scientifically validated psychotherapies, primarily Cognitive Behavioral Therapy (CBT), and accessible via an iOS and Android application, or to
- a comparison condition without CBT and conversation, though still delivered in an interactive smartphone application that is accessible anytime of day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years who had onset of a major depressive episode within the third trimester of pregnancy or within 4 weeks following delivery as measured by the MINI (Mini International Neuropsychiatric Interview).
- •Current mild-moderate depression as measured by the HAM-D (HAM-D score>13 and <24)
- •Women were </= to 6 months postpartum at the time of screening
- •Owns a smartphone (Anrdroid or iOS smartphone with a recent, supported operating system)
- •Available and committed to engage with the program and complete assessments for a 3-month duration
- •Able to read and write in English
- •U.S. resident
排除标准
- •HAM-D score ≥ 24 (severe depression)
- •Active psychosis
- •Suicidal attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
- •History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
- •Current pregnancy or plans to become pregnant within the next 4 months
- •Fetal demise within the past 24 months
- •Previous Woebot user
结局指标
主要结局
Hamilton Depression Rating Scale for Depression (HAMD)
时间窗: Post-treatment at 8 weeks
The HAMD is a 17-item, clinician rated measure of depression. Each item is scored from 0 to 2 and assesses the following criteria: insomnia, somatic symptoms, genital symptoms, loss of weight, and insight. The total score is calculated as a sum and ranges from 0 to 52, with higher scores indicating a greater degree of depression. The HAMD is commonly used for diagnostic purposes in research; structured clinical interviews such as this are recommended to actually diagnose clinical depression. It will be the primary outcome measure.
次要结局
- Clinical Characteristic Questions(Baseline, Post-treatment at 8 weeks)
- The Patient Health Questionnaire (PHQ-8)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
- Generalized Anxiety Disorder 2-item scale (GAD-2)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
- The Mother-to-Infant Bonding Scale (MIB)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS)(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks)
- The Edinburgh Postnatal Depression Scale (EPDS)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
- The Mental Health Self-Efficacy Scale (MHSES)(Baseline, Mid-Treatment at 4 weeks, Post-treatment at 8 weeks, 1-Month Follow-up at 12 weeks)
- The Client Satisfaction Questionnaire (CSQ-8)(Post-treatment at 8 weeks)
研究者
研究点 (2)
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