Online mindfulness-based intervention for women with pregnancy distress: A randomized controlled trial

Background: Pregnancy distress among childbearing women is common and can negatively affect both mother and infant. Mindfulness-based interventions (MBIs) may have a positive effect on pregnancy distress but ran-domized controlled trials with sufficient power are lacking. The current study examined the effectiveness of an online self-guided MBI in pregnant women with pregnancy distress.Methods: Pregnant women with elevated pregnancy distress levels at 12 weeks of pregnancy, measured with the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale negative affect (TPDS-NA), were ran-domized into an intervention group (online MBI, N = 109) or control group (care as usual, N = 110). The primary outcome was the change in pregnancy distress post-intervention and at eight-weeks-follow-up. Secondary out-comes were mindfulness skills (Three Facet Mindfulness Questionnaire-Short Form), rumination (Rumination -Reflection Questionnaire), and self-compassion (Self-Compassion Scale-Short Form) at post-intervention and follow-up in the intervention group.Results: Significant improvements were found in pregnancy distress scores, but no significant differences between intervention and control group appeared. The MBI group showed improvements in mindfulness skills, rumina-tion, and self-compassion. Limitations: Low adherence to the intervention and assessment of secondary outcome measures in the inter-vention group only.Conclusions: An intervention trial with one of the largest samples (N = 219) provided no evidence of a significant effect of an online self-guided MBI in distressed pregnant women. An online MBI may be associated with an improvement in mindfulness skills, rumination, and self-compassion. Future research should address the effec-tiveness of MBI's with different formats (online and group-based combined) and examine a possible delayed effect.Trial registration: ClinicalTrials.gov: NCT03917745, registered on 4 March 2019.