Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 6
- 主要终点
- Maternal well-being
研究概览
简要总结
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are:
- Does the app improve overall maternal well-being during the perinatal period?
- Can the app increase the early detection rates of perinatal mental health disorders?
- Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems?
- How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants?
Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes.
Participants will:
- Use the mobile application from 12-14 weeks of gestation until 24 months postpartum.
- Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data.
- Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old.
This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.
详细描述
BACKGROUND:
Mental disorders are becoming one of the major health problems in today's society, exacerbated in women who are and will become mothers. Global studies indicate that 80% of women who are going to become mothers experience mood disorders such as stress, fear, loneliness, or guilt during the perinatal period. In 1 out of every 5 cases, these mental disorders worsen and lead to severe mental health issues such as post-traumatic stress disorder, psychosis, suicidal ideation, or postpartum depression. However, 75% of women with perinatal mental disorders are underdiagnosed and do not receive adequate treatment, either due to a lack of detection or support within healthcare systems. This has a consequent impact on the health and well-being of the mother, her family, the child, and ultimately, society. In this context, the company A Thousand Colibris S.L (ATC) has developed digital health software to improve well-being during this period, as well as to detect, assist in the diagnosis, and monitor mental health disorders in mothers from pregnancy up to two years after childbirth.
Consequences of Perinatal Mental Health Disorders:
The consequences of perinatal mental health problems extend beyond the mother, affecting the child, the family, and society as a whole.
- Maternal health disorders: Perinatal mental health disorders have been identified in women of all cultures, ages, social levels, and races. Although the term postpartum depression is often used to describe disorders that develop after childbirth, a range of disorders can appear during pregnancy and the postpartum period, including anxiety, depression, stress disorders, panic, or postpartum psychosis. If left untreated, these illnesses can have a devastating impact on women and their families, being one of the leading causes of maternal death during pregnancy and the two years following childbirth.
- Impact on the future health of the child: Without appropriate intervention, these disorders can persist and have negative consequences for both the mother and the baby. The impact of the mother's health on the future health of the baby, on mother-newborn interactions, breastfeeding difficulties, and the mother-child bond is well documented. The failure to detect certain aspects of maternal health can manifest in complications during childbirth or later in the child's development.
- Impact on family well-being: The mother's mood and symptoms of anxiety and other disorders also have a direct impact on the partner, who may not understand what is happening, feel overwhelmed, and not know how to help.
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)
盲法说明
Participants will download an app that will randomise them on the intervention or control group.
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
- •Gestational age between 12-14 weeks of gestation.
- •The first obstetric ultrasound has been performed.
- •Women who know how to read and understand Spanish.
- •Women who have access to a mobile phone with an internet connection (data or wifi)
- •Women who have knowledge of technology tools via app.
- •Have signed the informed consent to participate in the study.
排除标准
- •Termination of pregnancy, or early miscarriage
- •Perinatal loss at any time during pregnancy.
- •Severe mental pathology or moderate unstable mental pathology.
- •Consumption of toxic substances.
结局指标
主要结局
Maternal well-being
时间窗: 12-14 weeks, 33-34 weeks of gestation, 6 weeks, 6, 12, 24 months postpartum.
Assessed using the World Health Organization-5 Well-Being Index (WHO-5). The WHO-5 is a brief 5-item self-report instrument designed to measure current mental well-being. It has adequate validity for screening depression and measuring clinical trial outcomes, with good properties when used in pregnant women (Mortazavi et al., 2021). Min value: 0 Max value: 25 Higher scores: Indicate better well-being. Scores below 13 suggest poor well-being, indicative of depression.
次要结局
- Depression(12-14 and 29-30 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.)
- Anxiety(12-14 and 33-34 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.)
- Birth Fear(12-14 and 33-34 weeks of pregnancy, 6 weeks postpartum.)
- Maternal Antenatal attachment(29-30 weeks of pregnancy.)
- Bonding(6 weeks, 6, 12, 24 months postpartum.)
- Birth Experience(33-34 weeks of pregnancy, 6 weeks postpartum.)
- Traumatic stress responses related to childbirth(6 weeks postpartum)
- Health costs 1(1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period.)
- Health costs 2(1 week after birth collected retrospectively for pregnancy and childbirth. 2 years postnatally collected retrospectively for the postnatal period.)
- Parental stress(6, 12, 24 months postpartum.)
- Sleep(12-14 and 33-34 weeks of pregnancy)
- Neonatal outcomes 1(1 week after birth collected retrospectively)
- Neonatal outcomes 3(1 week after birth collected retrospectively)
- Neonatal outcomes 6(1 week after birth collected retrospectively)
- Neonatal outcomes 7(1 week after birth collected retrospectively)
- Birth outcomes 1(1 week after birth collected retrospectively)
- Birth outcomes 2(1 week after birth collected retrospectively)
- Birth outcomes 4(1 week after birth collected retrospectively)
- Maternal empowerment(Postpartum: 6 weeks and 24 months)
- Physical Activity(12-14 and 33-34 weeks of pregnancy.)
- Pregnancy outcomes(1 week after birth collected retrospectively for pregnancy and childbirth)
- Neonatal outcomes 2(1 week after birth collected retrospectively)
- Neonatal outcomes 5(1 week after birth collected retrospectively)
- Birth outcomes 3(1 week after birth collected retrospectively)
- Biomarkers 1 (stress)(From 12 weeks of pregnancy until 2 years postpartum)
- Breastfeeding outcomes(Postpartum: 4 months, 1 year after childbirth collected retrospectively)
- Neonatal outcomes 4(1 week after birth collected retrospectively)
- Biomarkers 3 (activity)(From 12 weeks of pregnancy until 2 years postpartum)
- Biomarkers 2 (sleep)(From 12 weeks of pregnancy until 2 years postpartum)
- Birth outcomes 5(1 week after birth collected retrospectively)
- Child neurodevelopment(4 months and 24 months postpartum.)
- Adaptative behaviour(4 months and 24 months postpartum.)