Journal of affective disorders · 2026
Non-specialist-delivered tiered iCBT for perinatal depression in primary care: An effectiveness and cost-effectiveness pragmatic trial.
Контролируемое клиническое исследованиеСтатьяPragmatic Clinical TrialНазвание и аннотация: Перевод в очереди
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Jiang Minmin, Tang Chengli, Zhang Houlin, Lu Mengjuan, Gu Yue, Shao Shanshan, Hou Yanyan, Yu Xiayan, Li Haiyan, Liang Yan, He Congling, Shang Mengqing, Zhen Hualong, Gao Hui, Weng Tingting, Yan Shuangqin, Tao Fangbiao, Zhu Beibei
Аннотация
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.
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.