"Mamma Mia" for Perinatal Health and Wellness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,757
- 试验地点
- 1
- 主要终点
- Change in depression symptom severity
研究概览
简要总结
The purpose of this research study is to find out about ways to enhance well-being during pregnancy and the postpartum period (after the baby is born). The "Mamma Mia" program and/or guided support from study staff ("Mamma Mia Plus") may be helpful because the app provides skills and information related to many important topics during and after pregnancy. This study will allow us to learn more about whether and how the program is helpful to women.
详细描述
This study will compare findings in women who do not use the program ("usual care group") versus women who use the program ("Mamma Mia group") versus women who use the program and receive regular contact from study staff ("Mamma Mia Plus"). The study will assess well-being, depression, stress, and anxiety as well as whether certain factors (for example, women's age, type of healthcare provider, amount of social support) are related to the effects of the program. For women randomized to use the program, the study will also collect information about the time spent using it and the modules completed.
Usual prenatal and postpartum care involves regular visits with participant's women's health care provider while pregnant and after the baby is born. In this study, participants will receive continue receiving usual care. In addition, participants will be randomly assigned (like the flip of a coin) to participate in one of the following groups:
- The "usual care group", or
- The "Mamma Mia group" (which is to use the "Mamma Mia" program regularly), or
- The "Mamma Mia Plus group" (which is to use the program regularly plus receive regular contact with study staff).
There is a 1 chance in 3 of being assigned to each of the three groups. participants have an equal chance of being assigned to any one of the groups.
Participants in the "usual care group" will be asked to do the following things:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •pregnant woman <25 weeks gestation;
- •age 18 or older;
- •speak, read, and understand English;
- •have the ability to access an internet/mobile-based program (via computer, tablet, or smartphone), and have a working phone number and a working email address.
排除标准
- 未提供
研究组 & 干预措施
Usual care group
Usual prenatal and postpartum care involves regular visits with one's health care provider while pregnant and after the baby is born.
Mamma Mia group
Usual prenatal/postpartum care plus use of the "Mamma Mia" program
干预措施: Mamma Mia (Device)
Mamma Mia Plus group
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
干预措施: Mamma Mia (Device)
Mamma Mia Plus group
Usual prenatal/postpartum care plus use of the "Mamma Mia" program plus occasional contacts from study staff
干预措施: Mamma Mia Plus (Other)
结局指标
主要结局
Change in depression symptom severity
时间窗: Baseline to 6 months postpartum, about 11 months
measured by the Edinburgh Postpartum Depression Scale
Change in Depression Symptom Severity
时间窗: Baseline to 6 months postpartum, about 11 months
Measured by the Edinburgh Postpartum Depression Scale (EPDS), it uses a 10-item self-report questionnaire that screens for symptoms of depression and anxiety during pregnancy and the first year postpartum. Mothers are asked to select the answer that comes closest to how they have felt over the past 7 days. Each of the 10 questions is scored from 0 to 3, yielding a maximum total score of 30. Some questions (items 3, 5, 6, 7, 8, 9, 10) are reverse-scored (e.g., 3, 2, 1, 0 instead of 0, 1, 2, 3). 0-9 (minimal to no symptoms): Indicates some distress that is likely short-lived. Monitoring is usually recommended if symptoms persist. 10-12 (Mild Distress): Indicates discomforting symptoms. Healthcare providers often suggest a repeat screen in 2 weeks. 13 or higher (Probable depression): Scores at or above this threshold typically signify a positive screen. Further clinical evaluation and potential referral to a mental health professional are strongly recommended.
次要结局
- Change in anxiety(Baseline to 6 months postpartum, about 11 months)
- Change in stress(Baseline to 6 months postpartum, about 11 months)
- Change in subjective well-being(Baseline to 6 months postpartum, about 11 months)
- Change in Subjective Well-being(Baseline to 6 months postpartum, about 11 months)
- Change in Stress(Baseline to 6 months postpartum, about 11 months)
- Change in Anxiety(Baseline to 12 week post-postpartum)