Digital Mindfulness Intervention for Pregnant Women With Affective Disorders and Acute Stress Reactions: Prespecified Secondary Analysis of a Randomized Controlled Trial.

The short version

This prespecified secondary analysis of a German randomized trial included 147 pregnant women with elevated depressive symptoms and a diagnosed mood, anxiety or stress-related disorder. It compared an 8-week app-based mindfulness program with usual care. Pregnancy and the first weeks after birth are a high-risk period for depression and anxiety, up to one in four pregnant women are affected, and medication choices are limited during pregnancy and breastfeeding. The researchers asked whether a self-guided digital mindfulness program, which trains attention to the present moment, helps women who already have a psychiatric diagnosis, a group not previously studied for digital mindfulness during pregnancy. Women were recruited through university hospitals and more than 200 gynecology practices in Baden-Wurttemberg after screening above 9 on the Edinburgh Postnatal Depression Scale (EPDS, a 10-item, 0-30 depression questionnaire). Half (73 women) received eight weekly 45-minute app sessions between weeks 29 and 36 of pregnancy with no therapist contact; the other half (74) received usual obstetric and mental health care. Depression, anxiety and pregnancy-related fears were rated by questionnaire through 6 months after birth. Depression scores were lower in the app group than in usual care by 2.21 points at week 34, 3.25 at week 36 and 4.81 at 4-6 weeks postpartum (P = .01, .01 and .007), a large effect (Cohen d = 1.25). At that point 42.5% of the app group had improved by 4 or more EPDS points compared with 28.4% of usual care (odds ratio 1.56 in observed cases, P = .001), and 36.9% versus 21.6% were in remission. General anxiety scores also fell, but several anxiety effects were no longer significant under conservative assumptions about missing data, and fears specific to pregnancy and birth did not differ. By 6 months postpartum the differences were no longer statistically significant. Nearly half of postpartum questionnaires were missing (47.9% app, 40.5% usual care). The authors suggest digital mindfulness may be a scalable add-on to perinatal mental health care and that booster sessions after birth might help. Limitations they list include heavy postpartum dropout, possible overestimation of benefit in the responder analyses, too few women with rarer diagnoses to analyze, and no comparison with medication. The authors also note that an 8-week antenatal program alone may not be enough for lasting effects in women with existing disorders, and the paper defines remission inconsistently (an EPDS score of 9 or higher in the methods, 9 or lower in the tables).

Key findings

• In a German randomized trial subgroup of 147 pregnant women with elevated depressive symptoms and a diagnosed mood, anxiety or stress-related disorder, an 8-week self-guided mindfulness app lowered depression scores (Edinburgh Postnatal Depression Scale, EPDS) more than usual care at gestational weeks 34 and 36 and at 4-6 weeks after birth (difference 4.81 points, P = .007).
• At 4-6 weeks postpartum, 42.5% of the app group versus 28.4% of the usual-care group improved by 4 or more EPDS points and 36.9% versus 21.6% were in remission; anxiety scores also fell but several effects disappeared under conservative missing-data assumptions, and pregnancy-specific fears did not differ.
• By 6 months postpartum the group differences were no longer statistically significant, and 40.5% to 47.9% of the 4-6 week postpartum depression scores were missing (more in the app group), so the postpartum findings are uncertain.
• The authors suggest digital mindfulness could be a scalable add-on to perinatal mental health care and propose postpartum booster sessions, but this subgroup analysis did not compare the app with medication or an active control.

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