Bonding Before Birth: A Cluster-randomized, Controlled, mHealth Trial for Developing Mindfulness and Emotional Regulation in Expectant Couples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 572
- 试验地点
- 1
- 主要终点
- Parents' Depressive Symptoms
研究概览
简要总结
Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms.
This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.
Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health.
Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.
详细描述
The overall goal of this study is to answer the following main questions:
- Does the intervention improve parents' depressive symptoms scores, using the Edinburgh Postnatal Depression Scale as a proxy?
- Does the intervention improve parents' emotional regulation skills?
The study involves 286 expectant couples (572 individuals) in a two-arm, cluster-randomized controlled trial with longitudinal observational follow-up until the child turns 6 months old. The active intervention comprises of customized, weekly recommendations of short (2-5 minute) audio clips featuring activities such as breathing exercises, meditation, mindful walking. These will be provided to adult participants (expectant couples). Couples enrolling in the study will randomly be allocated to either the control or intervention group by prespecified block sizes of 10. That is, a random number generator will be used to preset the assignments in groups of 10, such that every 10 consecutive enrolments will have exactly 5 controls and 5 interventions (1:1 allocation). While it is not possible to blind operational staff to assignments (different protocols to follow, highly unbalanced assignment), scheduling of enrolment visits will be done by different staff than those conducting the enrolment visits, and the assignment will only be made known to enrolment staff while conducting the visit itself and they will also not have access to the blocking and randomization algorithm.
Participants in the control, no-intervention group will have access to a mobile app with similar functions as the participants in the intervention group, except that no personalized modules are given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
Participants in the intervention group will have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Participants will also be re-randomized weekly to different modules within the app. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
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 unaware of their group allocation (intervention or control). While it is not possible to blind operational staff to assignments (different protocols to follow, highly unbalanced assignment), scheduling of enrolment visits will be done by different staff than those conducting the enrolment visits, and the assignment will only be made known to enrolment staff while conducting the visit itself and they will also not have access to the blocking and randomization algorithm.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-50 years of age
- •Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment
- •Singleton pregnancy
- •Nulliparous
- •Plan to deliver in Singapore
- •Proficient and able to respond to questionnaires in English
- •Intends for herself and her child to stay in Singapore for the next 2 years
- •Access to a smartphone
- •Willing to download the study app
- •Score of 7 or more in the Edinburgh Postnatal Depression Scale
- •21-75 years of age
- •Proficient and able to respond to questionnaires in English
- •Intends for himself and his child to stay in Singapore for the next 2 years
- •Access to a smartphone
- •Willing to download the study app
排除标准
- •Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders
- •Currently on oral/IV steroids and/or thyroid medication
- •History of thyroid disease
- •Pregnant using assisted reproductive technologies
- •Multiple pregnancies
- •Currently enrolled in interventional randomised controlled trials
- •Responded "Yes, quite often" to EPDS item 10 ("The thought of harming myself has occurred to me")
- •1. Currently enrolled in interventional randomised controlled trials
研究组 & 干预措施
Group A (Control)
Participants' will have access to a mobile app with similar functions as the participants in the intervention group, except that there are no personalized modules given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
Group B (Intervention)
Participants have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
干预措施: Group B (Intervention) (Behavioral)
结局指标
主要结局
Parents' Depressive Symptoms
时间窗: Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. A composite outcome of the three postnatal EPDS measurements will be used as a primary outcome assessment
Parents' level of depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale.
次要结局
- Parents' emotional regulation skills(Administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months.)
研究者
Michelle Kee
Principal Scientist
Institute for Human Development and Potential (IHDP), Singapore