InBloom App vs ROSE Outcomes and Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- mean depression severity measured using Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
A randomized trial of pregnant people at risk for postpartum depression comparing the InBloom app (n = 76) to ROSE (n = 76; weekly scheduled group), and two control groups. We will assess Depression at baseline and 1, 2 and 3 months, ROI at 3 months, Satisfaction at 1 and 3 months and Perceived Access at 1 and 3 months. Subject participation will last up to 8 months (minimum 17 weeks pregnant through 3 months postpartum).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •17-32 weeks pregnant
- •enrolled for prenatal care in one of the five identified practices
- •English speaking
- •able to use an app (audio/visual/dexterity)
- •have one or more of the following PPD risk factors: Medicaid eligible; anxiety (GAD-7 > 10) during pregnancy; mild to moderate depressive symptoms (PHQ-9 = 10-19); self-reported history of depression treatment; gestational diabetes; and/or young age (18-21 years).
排除标准
- •patients with acute mental health needs
- •cannot communicate in English
- •demonstrate significant cognitive impairment
- •are planning to place the child for adoption
- •PHQ-9 depression score > 19
- •younger than age 18
研究组 & 干预措施
women receiving InBloom app
干预措施: InBloom (Device)
women receiving ROSE as usual
干预措施: ROSE (Behavioral)
historical controls- no treatment
We will capitalize on data from a large ROSE trial which consists of a demographically similar sample by comparing depression diagnosis outcomes for Inbloom and ROSE to the 96 participants in the care as usual group (an educational pamphlet on PPD).
electronic health record utilization data
We will leverage EHR utilization data by retrospectively identifying 152 people from the same clinics who did not receive ROSE or InBloom and matched for eligibility criteria, demographics and PPD risk factors using propensity scores, and comparing their utilization to those in the ROSE and InBloom groups.
结局指标
主要结局
mean depression severity measured using Patient Health Questionnaire (PHQ-9)
时间窗: 3 months
PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.
proportion of participants with post-partum depression assessed using the Mini International Neuropsychiatric Interview (MINI)
时间窗: 3 months
The MINI is a binary assessment of the diagnosis of postpartum depression. It yields a yes, no answer.
mean depression severity measured using Patient Health Questionnaire (PHQ-9)
时间窗: baseline
PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.
mean depression severity measured using Patient Health Questionnaire (PHQ-9)
时间窗: 1 month
PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.
mean depression severity measured using Patient Health Questionnaire (PHQ-9)
时间窗: 2 months
PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.
次要结局
- Return on Investment (ROI)(3 months)
研究者
Ellen Poleshuck
Professor
University of Rochester