Mindfulness in High Risk Pregnancies

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.

To date, there have been no studies that have looked at Mindfulness as a tool for mothers admitted due to risk of preterm delivery. The study being proposed here, would assess the impact of mindfulness in the prenatal period, in a group of mothers who are experiencing elevated levels of depression, anxiety and stress due to the risk of preterm delivery.

HYPOTHESIS

The investigators hypothesize that pregnant women will experience less depression, anxiety and stress with mindfulness and will increase their mindful awareness.

MATERIALS AND METHODS

This study is a non blinded, prospective randomized controlled trial.

Following recruitment of participants, randomization into either the mindfulness group or the control group will occur.

Mindfulness Group (MG)

Participants within the mindfulness group will be instructed by a mindfulness practitioner/coach once a week for four weeks in one-on-one sessions. Weekly journals will be provided to measure adherence. Optional mindfulness audio files may be used to continue mindfulness practice in between guided mindfulness sessions.

Control Group (CG)

Participants within the control group will receive care as usual without any additional mindfulness techniques provided during the four-week period.

Instruments

* General Demographic Form: A researcher created maternal demographic data form (age, educational level, number of gestations, parity, prior experience with mindfulness, history of depression and anxiety) to be completed by the mother at enrolment. * Depression, Anxiety and Stress Scale: 21 item Depression, Anxiety, Stress Scale to be completed by the mother at enrolment and at the end of the four weeks. * Pregnancy Related Anxiety Scale: 10 item Pregnancy Related Anxiety Scale to be completed by the mother at enrolment and at the end of the four weeks. * Mindfulness Scales: 15 item Mindfulness Attention Awareness Scale and the 13 item Toronto Mindfulness Scale will be completed by the mother at enrolment and at the end of the four weeks. * Mindfulness Weekly Journal: Document recording the duration of mindfulness practice every day during the four-week intervention to assess adherence.

COVID-19 info

There will be in-person recruitment and data collection, but all in-person interactions will be put on hold until social distancing requirements have been lifted.

DATA ANALYSIS

Study data will be managed using Research Electronic Data Capture, a secure, web-based software platform, hosted at the University of Alberta. Group demographics were compared with t-test, chi-square and Mann-Whitney U as appropriate. The scores of the four questionnaires will be analyzed with the Wilcoxon Signed-Rank test for within group comparison and the Mann-Whitney U test for between group comparisons. The Spearman correlation test will be used in the mindfulness group for correlation between the mindfulness scores and the stress, anxiety and depression scores. 2-tailed p-values will be used.

• Mindfulness practice [Time frame: 4 weeks]
• Gestational age [Time frame: variable (less than 20 weeks from recruitment)]