{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T10:16:59Z","timestamp":1788517019017,"version":"build-2803163510"},"reference-count":45,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Med Internet Res"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n \n Pregnant women with\n ICD-10<\/jats:italic>\n (\n International Statistical Classification of Diseases, Tenth Revision<\/jats:italic>\n ) affective or stress-related disorders face an elevated risk of perinatal depression and anxiety, yet evidence on digital nonpharmacologic interventions for this population remains limited.\n <\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n This study evaluated the effectiveness of an 8-week digital mindfulness\u2013based intervention (eMBI) compared with treatment as usual (TAU) among pregnant women with\n ICD-10<\/jats:italic>\n affective or stress-related disorders participating in a randomized controlled trial (RCT).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This prespecified secondary analysis was conducted within a multicenter RCT in Baden-W\u00fcrttemberg, Germany. Pregnant women aged 18 years and older with elevated depressive symptoms (Edinburgh Postnatal Depression Scale [EPDS]>9) and\n ICD-10<\/jats:italic>\n \u2013diagnosed affective or stress-related disorders were randomized 1:1 to eMBI or TAU. The intervention consisted of 8 weekly app-based mindfulness sessions (45 min each) delivered during gestational weeks 29\u201036, with no direct therapist contact. The primary outcome was continuous depressive symptom severity measured with the EPDS at 4\u20106 weeks post partum. Secondary outcomes included the EPDS at 6 months post partum, generalized anxiety (State-Trait Anxiety Inventory-State [STAI-S], State-Trait Anxiety Inventory-Trait [STAI-T]), and Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R). Analyses followed the intention-to-treat (ITT) principle, using mixed models for repeated measures and multiple imputation.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of the 5299 screened women, 147 met the inclusion criteria for this subgroup analysis (intervention group [IG] had n=73 women and control group had n=74 women). Groups were comparable at baseline. The IG showed significantly greater reductions in EPDS scores at gestational week 34 (\u0394=\u20132.21,\n P<\/jats:italic>\n =.01), week 36 (\u0394=\u20133.25,\n P<\/jats:italic>\n =.01), and 4\u20106 weeks post partum (\u0394=\u20134.81,\n P<\/jats:italic>\n =.007). Treatment effects remained robust under conservative missing-data assumptions. At 4-6 weeks post partum, a higher proportion of participants in the IG achieved clinically meaningful improvement (31\/73, 42.5% vs 21\/74, 28.4%; adjusted odds ratio 1.56, 95% CI 1.19\u20102.05;\n P<\/jats:italic>\n =.001). Anxiety outcomes followed a similar pattern, whereas pregnancy-related anxiety did not differ between groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n In this prespecified subgroup of pregnant women with\n ICD-10<\/jats:italic>\n affective or stress-related disorders, the eMBI was associated with clinically meaningful reductions in depressive symptoms from late pregnancy to 4-6 weeks post partum. Effects at 6 months post partum were attenuated and less stable across missing-data assumptions. These findings support eMBIs as a scalable, nonpharmacological adjunct to perinatal mental health care for women with affective or stress-related disorders, while confirmation in adequately powered trials with strategies to reduce postpartum attrition is warranted.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/93811","type":"journal-article","created":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T20:45:06Z","timestamp":1780519506000},"page":"e93811-e93811","source":"Crossref","is-referenced-by-count":0,"title":["Digital Mindfulness Intervention for Pregnant Women With Affective Disorders and Acute Stress Reactions: Prespecified Secondary Analysis of a Randomized Controlled 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