The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting.

Background: Stress and mental disorders in pregnancy can adversely affect the developing fetus. Women with a preconception history of mental disorders or of psychosocial vulnerabilities are at increased risk of experiencing perinatal stress or mental health problems. Mindfulness-Based-Stress-Reduction (MBSR) is an acceptable intervention for pregnant women and has a growing evidence-base with meta-analyses consistently pointing to reductions in symptoms of stress, anxiety and depression. This study protocol aim to address the need for a wider array of evidence-based and non-pharmacological options during pregnancy to reduce stress and improve mental health in a psychosocially highly vulnerable group of women.

Methods: Pregnant women with a preconception history of mental disorders or psychosocial vulnerabilities (n = 240) will be recruited from an obstetric ambulatory clinic at Copenhagen University Hospital, Hvidovre, Denmark. Recruitment for the study began in March 2022 and will continue until the desired number of participants is reached. Consenting pregnant women will be randomized to one of two study arms, an adapted MBSR program as add on to usual care or usual care alone. The primary outcome is mental wellbeing at nine months post-randomization. Secondary and exploratory outcomes include stress, anxiety, depression, and maternal antenatal attachment, experience of childbirth, delivery and mode of delivery. Mindfulness and self-compassion are examined as possible mediators of the effect on outcomes.

Discussion: Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to improve mental health and wellbeing during pregnancy, reduce stress and support the transition to parenthood. Mindfulness-Based Stress Reduction does not target a particular group, and results from the study is thus of potential relevance for pregnant women in general as a means of reducing stress and improving perinatal mental health and wellbeing.

Trial Registration: ClinicalTrials.gov: NCT05300646 . Registered March 29, 2022.