E-health intervention in women with pregnancy distress: a randomized controlled trial

During pregnancy, women are at risk for mental health problems: up to 20% present with distress symptoms (depression and/or anxiety). Apart from the adverse effects on the woman herself, pregnancy distress negatively affects pregnancy outcome (such as increased risk of pregnancy induced hypertension, preterm birth), poor fetal health (small for gestational age (SGA)) as well as impaired postpartum mother-child interaction and child neuro- and social-emotional development. Mindfulness-based interventions (MBIs) are a type of intervention that is increasingly being used to treat symptoms of stress, anxiety and depression. Research demonstrates positive effects of MBIs, such as reduced levels of stress, anxiety, depression and negative affect. MBIs during pregnancy show promising positive effects on maternal distress; however, there is a clear need for high-quality RCTs with sufficient power. Moreover, e-health interventions for mental health problems in general have become increasingly popular during the last decades. They are cheap and accessible to the whole population. The current study aims to examine the effectiveness of a recently developed e-health intervention program at Tilburg University (dr. I. Nyklícek, mindfulness expert): “Ontspannen Zwanger”, a mindfulness training to reduce distress during pregnancy. The current study is part of a large observational study (the Brabant Study, BS), starting in April 2018, in which up to 10.000 pregnant women and their offspring will be followed prospectively for several decades with special focus on the impact of pregnancy distress on the woman’s (future) health and on physical, behavioral and cognitive neonatal/infant health. In The Netherlands, up to 85% of all pregnant women start antenatal care with the community midwife. For the BS, women will be recruited at their first antenatal visit with the community midwife (around 8 weeks gestation). After inclusion, they will complete the Edinburgh Depression Scale (EDS) and the Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks gestation. The EDS is the most widely used self-rating scale to assess depressive symptoms in the perinatal period, also during pregnancy. The TPDS focusses especially on pregnancy related distress (worries about fetal health, worries about delivery, extent of partner involvement in pregnancy). Women with a high score on the EDS and/or TPDS will be randomly allocated into two groups: intervention or control (care as usual). The intervention group will receive eight online mindfulness training sessions of one hour/week, starting at 16 weeks pregnancy. Pregnancy distress will be assessed again using the EDS and TPDS at 28 weeks gestation. The intervention group will receive two additional measurements: immediately post-intervention (24 weeks gestation) and 8 weeks post-intervention (32 weeks gestation). The feasibility of the current project is based on several important infrastructural aspects. First, the current project is embedded within the BS, which facilitates the recruitment of women. Second, the project is embedded within the perinatal consortium South-East Brabant. The consortium, in which all midwives and obstetricians of the area are participating, will also facilitate the recruitment of pregnant women. Third, the applicants have an experience of over 25 years in setting up of birth cohorts (varying from 300 – 2200 women): the BS will be the 6th birth cohort in this area formed over the last 25 years. Scientists involved within the current project also have experience in setting-up web-based mental health interventions, including mindfulness courses. An important aspect of the current project is implementation. Therefore, within the current project several steps will be made to facilitate implementation of the course within integrative birth care in the country. The existing close collaboration with the consortium of the area of the BS will facilitate the implementation in the area. Moreover, collaborative meetings with the consortium will inform other areas about the proceedings of the study. Also, there is a large well organized Primary Care infrastructure PoZoB (Praktijkondersteuning Zuidoost-Brabant, representing 200 GPs) with a fully implemented Practitioner Mental Health Care nurse. The current program will be implemented within this organization. Finally, the fact that the intervention is web-based will contribute to an easy way of disseminating the course over the whole country. We have taken the advice of the reviewers and the client advisory board and critically reviewed the project for its feasibility and made the following fundamental changes to the protocol. The outcome measurements focus on the reduction of pregnancy distress using questionnaires administered via internet, which have made a postpartum home visit redundant. Moreover, women will have weekly contact with a mindfulness coach to guide them through the intervention.