Currently submitted to: Journal of Medical Internet Research
Date Submitted: Feb 20, 2026
Open Peer Review Period: Feb 21, 2026 - Apr 18, 2026
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A Digital Mindfulness Intervention for Pregnant Women With Affective Disorders and Acute Stress Reactions: A Prespecified Secondary Analysis of A Randomized Clinical Trial
ABSTRACT
Background:
Pregnant women with ICD-10 affective or stress-related disorders face elevated risk for perinatal depression and anxiety, yet evidence on digital non-pharmacologic interventions for this population remains limited.
Objective:
To evaluate the effectiveness of an 8-week digital mindfulness-based intervention (eMBI) compared with treatment as usual (TAU) among pregnant women with ICD-10 affective or stress-related disorders participating in a randomized clinical trial.
Methods:
This prespecified secondary analysis was conducted within a multicenter randomized controlled trial in Baden-Württemberg, Germany. Pregnant women aged ≥18 years with elevated depressive symptoms (Edinburgh Postnatal Depression Scale [EPDS] >9) and ICD-10–diagnosed affective or stress-related disorders were randomized 1:1 to eMBI or TAU. The intervention consisted of eight weekly app-based mindfulness sessions (45 minutes each) delivered during gestational weeks 29–36, with no direct therapist contact. Primary outcome was depressive symptom severity (EPDS) at 4–6 weeks postpartum. Secondary outcomes included EPDS at 6 months postpartum, generalized anxiety (STAI-S, STAI-T), and pregnancy-related anxiety (PRAQ-R). Analyses followed the intention-to-treat principle using mixed models for repeated measures and multiple imputation.
Results:
Of 5299 screened women, 147 met inclusion criteria for this subgroup analysis (intervention: n=73; control: n=74). Groups were comparable at baseline. The intervention group showed significantly greater reductions in EPDS scores at gestational week 34 (Δ=–2.21; P=.013), week 36 (Δ=–3.25; P=.013), and 4–6 weeks postpartum (Δ=–4.81; P=.007). Treatment effects remained robust under conservative missing-data assumptions. At 4–6 weeks postpartum, a higher proportion of participants in the intervention group achieved clinically meaningful improvement (42.5% vs 28.4%; adjusted odds ratio 1.56, 95% CI 1.19–2.05; P=.001). Anxiety outcomes followed a similar pattern, whereas pregnancy-related anxiety did not differ between groups.
Conclusions:
In this prespecified subgroup of pregnant women with ICD-10 affective or stress-related disorders, the use of a digital mindfulness intervention during pregnancy was associated with clinically meaningful reductions in depressive symptoms until 6 weeks postpartum. Even though effects at 6 months postpartum (T7) were smaller and statistically unstable across missing-data approaches, the digital mindfulness intervention effectively improved perinatal mental health in women with preexisting affective disorders, supporting its use as a safe, low-threshold alternative to pharmacological treatment during pregnancy and breastfeeding. Clinical Trial: DRKS00025697
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