Non-specialist-delivered tiered iCBT for perinatal depression in primary care: An effectiveness and cost-effectiveness pragmatic trial.

BACKGROUND

The shortage of mental health resources remains a major barrier to effective and scalable interventions for perinatal depression (PND). To address this challenge, this study evaluated the effectiveness of a tiered internet-based cognitive behavioral therapy (iCBT) intervention for PND, delivered by non-specialist health care providers (HCPs) within the primary care system.

METHODS

This pragmatic, non-randomized controlled trial enrolled pregnant women from two antenatal clinics in Hefei, China. Participants with an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 9 were allocated to the intervention group (N = 268) or control group (N = 160) based on their enrollment time. In addition to usual care, the intervention group received a tiered iCBT intervention (Mom's Good Mood, MGM), in which intervention intensity was matched to baseline depression symptom severity. The control group received usual care alone. The intention-to-treat principle was applied to test the significance of primary endpoints (the change in EPDS scores from baseline to 6 months postpartum) and secondary outcomes (including the proportion of women with postpartum depression (EPDS ≥9), the proportion achieving response (≥4-point EPDS reduction), changes in GAD-7 scores, the proportion with postnatal anxiety, and changes in life satisfaction scores). Linear mixed models (LMM), generalized linear mixed models (GLMM), sensitivity analyses, and a cost-effectiveness analysis were conducted.

RESULTS

Compared with controls, the intervention group showed a significantly greater reduction in EPDS scores from baseline to postpartum (Least-squares means, LSM, -1.63, 95% CI -2.62 to -0.64), a lower risk of postpartum depression (aOR = 0.46, 95% CI 0.27 to 0.79), and a higher odds of response (≥4-point reduction on EPDS, aOR = 1.70, 95% CI 1.05 to 2.76). Similar trends were observed for anxiety outcomes. Subgroup analysis showed more pronounced benefits for moderate to severe cases (LSM, -2.79, 95% CI -5.04 to -0.54; aOR = 0.20, 95% CI 0.06 to 0.68), while no significant effect was observed for mild cases. The intervention proved to be highly cost-effective, with an incremental cost of ¥5.5 (US$0.75) per 1% increase in response rate.

CONCLUSIONS

The tiered iCBT program MGM demonstrated significant effectiveness in reducing PND. Delivered by trained non-specialist HCPs within primary care settings, it optimizes resource use while enabling scalable mental health support.