Trial reportJournal of medical Internet research2025
Improving Maternal Mental Health and Weight Control With a Mindfulness Blended Care Approach: Insights From a Randomized Controlled Trial.
Trial report in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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11 authors.
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Abstract
backgroundPerinatal maternal mental health problems, such as depression and anxiety, are highly prevalent during pregnancy and post partum. Electronic mindfulness-based interventions (eMBIs) are a promising treatment option, which can be provided in a low-threshold, cost-effective manner. However, research underscores the fact that face-to-face coaching sessions are more effective than solely digital methods. A blended care approach (eMBI with direct face-to-face coaching) could amplify the therapeutic impact on maternal mental health and weight gain during the perinatal period.
objectiveWe investigated whether combining an eMBI intervention with face-to-face personal support significantly improves maternal mental health, and whether the intervention can influence weight gain in affected women during pregnancy.
methodsA community-based sample of 460 pregnant women with a singleton pregnancy who screened positive for depression was enrolled in a multicenter randomized controlled trial (RCT) including the University Hospitals of Heidelberg and Tübingen as well as more than 200 gynecological practices within the state of Baden-Württemberg in Germany between February 2019 and October 2020. Participating women were randomized 1:1 to the control group (CG) or intervention group (IG) that received access to an 8-week pregnancy-adapted eMBI between the 29th and 36th gestational week. In a subanalysis, we grouped participants in those receiving only the initial face-to-face coaching session at recruitment (no personal coaching) and those with ≥2 personal coaching sessions. Primary outcome measures were severity of depressive symptoms using the Edinburgh Postnatal Depression Scale, anxiety using the State-Trait Anxiety Inventory, the Pregnancy-Related Anxiety Questionnaire, the Freiburg Mindfulness Inventory, and the Patient Health Questionnaire; secondary outcome measure, BMI.
resultsIn the final sample, 137 CG women and 102 IG women received only one coaching session, whereas 37 CG women and 40 IG women received at least 2 (mean 2.3, SD 0.7) coaching sessions. The analyses were adjusted for significant confounders. The IG's mindfulness scores increased significantly (F
conclusionsAdding a minimal amount of PC to the digital eMBI increased mindfulness and decreased birth-related anxiety, symptoms of depression, and anxiety in at-risk pregnant women. Favorable effects on gestational weight gain were found in the respective IGs, the strongest effect being within the PC group. This blended digital health approach amplifies the effectiveness of the digital intervention.
trial registrationGerman Clinical Trials Register DRKS00017210; https://www.drks.de/search/de/trial/DRKS00017210.
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