The Impact of Mindfulness on Prenatal Depression, Anxiety and Stress in Mothers at Risk of Preterm Delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in stress symptoms
研究概览
简要总结
Anxiety, depression and stress are common during pregnancy. These have been found to negatively impact mother and child outcomes. When anxiety, depression, and stress are present in pregnant women, it is therefore important to manage them to improve the outcome of the mother and her child.
Although pregnancy itself has been shown to increase anxiety, depression and stress, these issues are further elevated in high-risk pregnancy groups. Mothers at risk of preterm delivery (less than 37 weeks gestational age), have been found to have higher rates of depression, anxiety and stress compared to uncomplicated term pregnancies. In addition, anxiety, depression and stress symptoms themselves increase the risk for preterm delivery, creating a vicious cycle for this high-risk group.
Mindfulness is a tool that has been during pregnancy to reduce depression, anxiety, and stress. Many studies have found mindfulness to be an appropriate management option in normal term pregnancies.
To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. This study will explore the impact of teaching mindfulness skills to inpatient mothers at risk of preterm delivery and studying its effects on maternal depression, anxiety, and stress.
This study involves providing Mindfulness strategies during the mother's inpatient admission for the risk of preterm delivery for four consecutive weeks. Participants will be enrolled through informed consent. All participants will be given pre and post participation questionnaires to examine the impact of mindfulness on anxiety, depression and stress. The participants will also be encouraged to maintain a weekly mindfulness log. The results of this research may lead to future studies looking at the impact of mindfulness practice for high-risk pregnancies. This will also help open up the possibility of offering such courses for inpatient and outpatient high-risk pregnancies in the future.
详细描述
BACKGROUND
Anxiety and depression are two of the most common psychological symptoms that manifest in pregnant women. A recent systematic review found the prevalence of prenatal anxiety to be 18.2% in the first trimester, 19.1% in the second trimester and 24.6% in the third trimester. A separate systematic review found rates of depression in the prenatal period to be 16.4%. These symptoms have been found to negatively impact maternal health as well as fetal and childhood development. It is therefore imperative that anxiety and depression be assessed in all pregnant mothers and to further implement interventions to improve outcomes for both the mother and fetus.
Pregnant mothers with admission to an inpatient ward due to increased risk for preterm delivery have been found to experience elevated levels of anxiety, depression and stress compared to term pregnancies. Furthermore, increased anxiety and depression have been linked to the risk of preterm labor, creating a vicious cycle. A 2017 study that assessed anxiety and depression in a population of pregnant mothers at risk of preterm labor found 35.1% to have anxiety and 69.8% having depressive symptoms. By managing the psychological symptoms experienced in this cohort of pregnant mothers, the rationale is that the risks associated with them might be reduced, providing improved maternal and fetal outcomes.
There have been several studies that have assessed the benefits of mindfulness as a tool in reducing anxiety, stress and depression specifically in pregnancy. A 2016 meta-analysis found that mindfulness-based interventions are effective at reducing pregnancy related depression, stress, and anxiety. A randomized controlled trial assessed pregnant women with high levels of stress and anxiety after six weeks of mindfulness practice with results demonstrating larger decreases in pregnancy specific anxiety as compared to the control group.
Mindfulness has been implemented as an intervention prior to delivery with encouraging results. It has also been used in the post-partum period in environments such as the Neonatal Intensive Care Unit (NICU), where parental anxiety, depression and stress are elevated due to admission of their newborn after birth. Recent studies have shown that when mindfulness is used in the NICU environment, it assists with reduction of depressive, anxiety and trauma symptoms as well as improving maternal sleep Mindfulness also helped mothers deal with acute stressors more appropriately and promoted awareness and reduced stress related emotions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 mothers admitted to the antepartum ward at the Lois Hole Hospital for risk of preterm delivery (< 34 weeks GA) are eligible for the study.
- •if they speak, read and write English,
- •if their inpatient stay is anticipated to be at least 4 weeks following recruitment
- •if they are willing and able to attend the mindfulness sessions.
排除标准
- •if they are experiencing current mental illness issues
- •if they are experiencing current or prior substance abuse
研究组 & 干预措施
Control
Standard of Care
Mindfulness Intervention
Mindfulness training
干预措施: Mindfulness (Behavioral)
结局指标
主要结局
Change in stress symptoms
时间窗: Change from recruitment to 4 weeks after
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of stress symptoms. Minimum score is 0. Maximum score is 21.
Change in depression symptoms
时间窗: Change from recruitment to 4 weeks after
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). A high score means a higher level of depression symptoms. Minimum score is 0. Maximum score is 21.
Change in anxiety symptoms
时间窗: Change from recruitment to 4 weeks after
using the Depression Anxiety Stress Scale -21. Scores for individual question range from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Minimum score is 0. Maximum score is 21. And using the Pregnancy Related Anxiety Scale. Scores for individual question range from 1 (Not at all) to 5 (Very much). Minimum score is 10. Maximum score is 50. A high score in both scales means a high level of anxiety symptoms.
Change in mindful awareness
时间窗: Change from recruitment to 4 weeks after
using the Mindfulness Attention Awareness Scale. Scores for individual question range from 1 (Almost Never) to 6 (Almost Always). Minimum score is 15. Maximum score is 90. And using Toronto Mindfulness Scale. Scores for individual question range from 0 (Not at all) to 4 (Very much). This scale has 2 subscales. Minimum score is 0. Maximum score is 24 for the first subscale and 28 for the second subscale. A high score in both scales (and subscales)means a high mindful awareness level.
次要结局
- Mindfulness practice(4 weeks)
- Gestational age(variable (less than 20 weeks from recruitment))