A randomized controlled trial comparing a mindfulness-based program with standard therapeutic follow-up during...

Pregnancy and childbirth represent a major transition into motherhood, marked by psychosocial changes that may increase women's vulnerability to mental health difficulties such as prenatal depression, anxiety, or PTSD, in addition to physical pain. These difficulties can negatively impact maternal well-being, the mother-infant relationship, and child development. Prenatal mindfulness-based interventions have shown positive effects on emotion regulation and prenatal attachment, but few studies have simultaneously examined their effects on maternal mental health, infant well-being, and early mother-infant interactions. This study will evaluate the effectiveness of a prenatal mindfulness program, compared to standard psychological care, on maternal positive and negative affect, infant well-being, and the quality of the mother-infant relationship.

Seventy pregnant women between 12 and 30 weeks of amenorrhea will be recruited and randomly assigned (1:1) to receive either a mindfulness program inspired by MBCP or standard psychological follow-up. Both groups will receive six individual sessions over six weeks. Self-report measures of maternal mental health, infant well-being, and attachment will be collected at T0, T1, T2, and T3. A filmed mother-infant interaction will be conducted at 12 months postpartum. Analyses will compare participant characteristics between the two groups.

The expected results will help clarify the psychological and interactional mechanisms involved and may support the integration of prenatal interventions aimed at improving maternal well-being, infant well-being, and attachment.

The study was registered with ClinicalTrials.gov (NCT07364032) and the Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12626000091303).