Abstract
Stress during pregnancy has been found to modify aspects of fetal development, including organ maturation and neurodevelopmental problems, and to increase the risk of preterm birth and lower birth weight. Studies have shown lower stress levels and cortisol release in people with high resilience. To date, no randomized controlled trial (RCT) has evaluated the effect of a resilience-building digital program to prevent and cope with stress in pregnancy. This study assessed the feasibility of conducting a web-based resilience-building RCT among otherwise healthy pregnant women. In total, 124 nulliparous women were included at their first antenatal appointment in gestational weeks 14-20. The women were randomly allocated to the intervention group consisting of a web-based resilience-building program lasting 20 weeks or to a control group receiving usual care. This study evaluated recruitment, attrition, adherence, satisfaction, and compliance rates using questionnaires on adherence and satisfaction and qualitative phone interviews with pregnant women to investigate the acceptability and feasibility of the intervention. The adherence rate was 85%. The overall satisfaction with participation in the study was six on an 8-point Likert Scale, ranging from "terrible" to "fantastic". In the intervention group, 58% had a "good" or "very good" experience with the program, and 62% reported still using knowledge and methods in the program two months postpartum. At follow-up, 57% had completed all four questionnaires. Some women described that using resilience exercises during pregnancy and birth was helpful for their overall well-being. However, some women found receiving email reminders of the exercises stressful. Overall, our feasibility study showed that the intervention was feasible and acceptable. Before conducting a full-scale trial, minor modifications to the program and the delivery can be considered to improve acceptability and response rate. The trial was registered in the clinicaltrials.gov database (ID NCT03854331) on 26/02/2019 and approved by the Danish Data Protection (J.nr. VD-2019-13) and the National Committee on Health Research Ethics - Capital Region (J.nr. H-19000990).