To analyze the intervention effectiveness of the Integrated Maternal and Mental Care Model (I2Mcare) for perinatal depression (PND) in primary maternal and child health institutions and explore its implementation process’s facilitators and barriers.

A hybrid type 1 randomized effectiveness-implementation trial was conducted. PND high-risk pregnant women were randomly assigned to an intervention group (receiving I2Mcare) or a control group (receiving routine maternal care). Four times of depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale. We use generalized linear mixed models to analyze the effect of intervention. Semi-structured interviews based on the Consolidated Framework for Implementation Research (CFIR) were administered to pregnant women and healthcare providers (n=27) to collect data on implementation factors. Qualitative data were analyzed by the thematic framework method.

A total of 153 pregnant women completed all 4 depression assessments, including 41 in the intervention group and 33 in the control group. No statistically significant differences in depression scores were found between the two groups during the first three assessments. However, in the fourth assessment, the depression score of the intervention group was significantly lower than that of the control group (P<0.05). Results from the Generalized Linear Mixed Models analysis indicated statistically significant effects for both the group difference (P=0.033) and the time effect (P<0.001). Key facilitators included the model’s relative advantages, China’s well-established maternal and child health system, strong foundational work from mental health departments and so on. Barriers encompassed insufficient public awareness, inadequate policy support and high clinical workload in obstetric departments.

The I2Mcare effectively alleviates depressive symptoms in high-risk pregnant women. Future scale-up should prioritize policy refinement, staff training, interdisciplinary collaboration, and public education.