Effectiveness of a Mindfulness-Based Mobile Intervention for Improving Perinatal Mental Health and Reducing Depression During Pregnancy: Randomized Controlled Trial.

Background: Pregnancy is a vulnerable period for women, with an increased risk of mental health issues such as depression and anxiety. The perinatal period is particularly important, as maternal mental health significantly impacts maternal physical health, pregnancy outcomes, postnatal outcomes, and fetal and infant development. Psychotherapeutic interventions for depression are essential, especially given the limitations of medication use during pregnancy. However, perinatal women experiencing depression often encounter barriers to accessing these interventions. Digital health interventions may offer a promising approach to overcome these barriers.

Objective: This study aimed to (1) evaluate the effectiveness of Avecmom, a self-help, mindfulness-based mobile intervention, in reducing depression severity among pregnant women with mild to moderate depression; (2) examine its impact on emotional well-being and maternal-fetal attachment; and (3) explore whether the effect on mental well-being is mediated by increased mindfulness and reduced depression severity.

Methods: Participants were recruited both online and offline. Of 158 screened individuals, 90 met the inclusion criteria and were randomly assigned to either the intervention or control group. The intervention group used both the Avecmom and Big 4+ apps, while the control group used only the Big 4+ app. Depressive symptoms, anxiety, and stress were assessed as primary outcomes at baseline and postintervention. Mindfulness, mental well-being, positive and negative emotions, and maternal-fetal attachment were assessed as secondary outcomes. Analysis of covariance (ANCOVA) was conducted with postintervention scores as the dependent variable, adjusting for baseline scores. To estimate the mechanism of change following Avecmom mobile app use, the bootstrapping technique with PROCESS Macro Model 6 was employed, applying the difference score from postintervention to baseline.

Results: A total of 86 pregnant women (intervention group: n=42; control group: n=42) completed the study and were included in the final analysis, reflecting an overall dropout rate of 4% (4/90). At postintervention, the intervention group demonstrated lower depression severity scores (F1,84=5.69; P=.02; partial ƞ2=0.06) and higher scores of mindfulness (F1,84=11.18; P=.001; partial ƞ2=0.12), maternal-fetal attachment (F1,84=5.54; P=.02; partial ƞ2=0.06), mental well-being (F1,84=8.79; P=.004; partial ƞ2=0.10), and positive affect (F1,84=7.21; P=.009; partial ƞ2=0.08) compared to the control group. Serial mediation analysis revealed that Avecmom app use influenced mental well-being through sequential improvements in mindfulness and decreases in depression severity (standardized β=.33; Boot SE=0.12, 95% CI 0.12-0.58).

Conclusions: Mindfulness-based mobile app interventions tailored for pregnant women may be more effective than self-monitoring alone in improving perinatal depression. These findings suggest that mindfulness-based mobile app interventions may help improve mental well-being in pregnant women, potentially by enhancing mindfulness and reducing depression severity.