Supporting Maternal Mental Health and Emotional Regulation (SuMMER): Assessment of the Clinical Effectiveness of a Mobile Application for Patients With Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- EPDS Score improvement
研究概览
简要总结
Primary Objective: Evaluate the clinical effectiveness of the MamaLift Plus app compared to control (digital sham plus treatment as usual) for the management of PPD in the observed population for a period of 9 calendar weeks. It is hypothesized that women who use the MamaLift Plus APP will experience less severe symptoms of depression in post-partum period than comparable women who do not and receive their usual care from health providers.
详细描述
Women between 18 and 50 years of age who have had a live birth within 3 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 200 women will be recruited to volunteer in the study with 166 assigned to the intervention arm and 37 assigned to the control group.
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
- Single (Participant)
盲法说明
Participants are not aware of whether they are receiving the MamaLift Plus interventional device or the digital placebo device. The applications have the same user interface and require a similar amount of time to complete activities. Participants in both arms will receive treatment as usual in addition.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be able to read, write and speak English;
- •Participants must provide written informed consent prior to enrollment;
- •Participants must be 18 to 50 years of age at the time of enrollment;
- •Participants must have had a live childbirth <=3 months prior to their enrollment into the study;
- •Participants who have a score of greater than or equal to 13 but not exceeding 19 on the Edinburgh Postnatal Depression Scale (EPDS) during initial screening visit/call;
- •Depression diagnosis needs to be confirmed by licensed behavioral health therapist or medical professional;
- •Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10);
- •Participants must be willing to use a mobile app and own an iOS or android enabled mobile phone or device;
- •Participants must have wireless internet connectivity in their home (or have access to internet connectivity) and be willing to connect devices via a Wi-Fi network
排除标准
- 未提供
研究组 & 干预措施
MamaLift Plus
Principles of Cognitive Behavioral Therapy used to treat PPD with App
干预措施: MamaLift Plus (Device)
Digital Sham App
Content on general mental health and wellbeing topics delivered with sham App
干预措施: Digital Sham App (Device)
结局指标
主要结局
EPDS Score improvement
时间窗: 9 week period
Proportion of women that improve EPDS to \< 13 points at their end of study assessment
EPDS Score
时间窗: 9 week period
Proportion of women that improve EPDS by \>= 4 points at their end of study assessment.
次要结局
未报告次要终点
研究者
Stan Kachnowski
Chair
Healthcare Innovation Technology Lab