L26/P-573 Effects of Mindfulness Therapy on Stress Biomarkers and Psychological Symptoms in Women with Recurrent Pregnancy Loss: A Randomized Clinical Trial

Abstract

Abstract Study question Does an online mindfulness-based intervention (MBI) improve psychological outcomes and salivary stress biomarkers in women with recurrent pregnancy loss (RPL)? Summary answer An 8-week online MBI improved psychological well-being and reduced symptoms of depression and stress in women with RPL, but did not alter salivary stress biomarkers. What is known already Women with RPL frequently experience high levels of psychological distress, negatively affecting quality of life. Mindfulness-based interventions have shown benefits for psychological outcomes in this population, but evidence from randomized controlled trials incorporating objective stress biomarkers is lacking. Study design, size, duration This was a single-center, randomized controlled trial conducted between July 2024 and March 2025. Thirty-five women with RPL were randomized to an intervention group or standard care and assessed before and after the 8-week intervention. Participants/materials, setting, methods Women aged ≥18 years with a history of at least two pregnancy losses were recruited from a tertiary academic hospital. Participants were randomized to either an online, group-based MBI (n = 18) or standard care (n = 17). Salivary cortisol, alpha-amylase, and immunoglobulin A (IgA) were measured as primary outcomes. Secondary outcomes included depression, anxiety, and stress (DASS-21) and psychological well-being (PGWB-I). Outcomes were analyzed using repeated-measures ANOVA under an intention-to-treat approach. Main results and the role of chance No significant time × group interactions were observed for salivary cortisol (p = 0.672), alpha-amylase (p = 0.342), or IgA (p = 0.148). In contrast, the MBI group showed significantly greater reductions in total DASS-21 scores (p = 0.018), depression (p = 0.026), and stress (p = 0.015), as well as marked improvements in overall psychological well-being (p < 0.001) and multiple PGWB-I domains. Greater psychological benefits were observed in younger women (p = 0.012) and those with higher baseline distress (p = 0.006). The number of previous miscarriages was not associated with treatment response. Limitations, reasons for caution The sample size was modest, potentially limiting power to detect changes in biological markers. Salivary cortisol was assessed using a single morning sample, which does not capture diurnal variation or stress reactivity. Long-term effects of the intervention were not evaluated. Wider implications of the findings Mindfulness-based interventions may represent a valuable adjunctive strategy to improve psychological well-being in women with RPL. While subjective benefits were evident, further studies with larger samples, longer follow-up, and more comprehensive biomarker assessment are needed to clarify potential biological effects. Trial registration number Yes