Anxiety experienced by women during pregnancy is highly prevalent, especially in resource-poor settings and strongly predicts postnatal common mental disorders (CMDs), anxiety and depression. We evaluated the effectiveness of an anxiety-focused early prenatal intervention on preventing postnatal CMDs. This study was a phase 3, two-arm, single-blind, randomized controlled trial conducted in Pakistan with women who were ≤22 weeks pregnant and had at least mild anxiety without clinical depression. Participants were randomized to the Happy Mother–Healthy Baby program, based on cognitive behavioral therapy, consisting of six one-on-one intervention sessions in pregnancy delivered by non-specialist providers, or to enhanced care alone. The primary outcome was major depression, generalized anxiety disorder or both at 6 weeks after delivery. Overall, 755 women completed postnatal assessments (380 (50.3%), intervention arm; 375 (49.7%) enhanced-care arm). The primary outcomes were met. Examined jointly, we found 81% reduced odds of having either a major depressive episode (MDE) or moderate-to-severe anxiety for women randomized to the intervention (adjusted odds ratio (aOR) = 0.19, 95% CI 0.14–0.28). Overall, 12% of women in the intervention group developed MDE at 6 weeks postpartum, versus 41% in the control group. We found reductions of 81% and 74% in the odds of postnatal MDE (aOR = 0.19, 95% CI 0.13–0.28) and of moderate-to-severe anxiety (aOR = 0.26, 95% CI 0.17–0.40), respectively. The Happy Mother–Healthy Baby program early prenatal intervention focusing on anxiety symptoms reduced postpartum CMDs. ClinicalTrials.gov identifier NCT03880032.

女性在怀孕期间经历的焦虑非常普遍，尤其是在资源匮乏的环境中，并且强烈预示着产后常见的精神障碍 (CMD)、焦虑和抑郁。我们评估了以焦虑为中心的早期产前干预对于预防产后 CMD 的有效性。这项研究是一项在巴基斯坦进行的 3 期、双臂、单盲、随机对照试验，受试者为怀孕 ≤22 周且至少有轻度焦虑但无临床抑郁症的女性。参与者被随机分配到基于认知行为疗法的快乐母亲-健康婴儿计划，该计划包括由非专业提供者提供的六次一对一的妊娠干预课程，或仅接受强化护理。主要结局是产后 6 周的重度抑郁症、广泛性焦虑症或两者兼而有之。总体而言，755 名女性完成了产后评估（干预组 380 名 (50.3%)；强化护理组 375 名 (49.7%)）。达到了主要结果。联合检查后，我们发现随机接受干预的女性患重度抑郁发作 (MDE) 或中度至重度焦虑的几率降低了 81%（调整后比值比 (aOR) = 0.19，95% CI 0.14–0.28）。总体而言，干预组中有 12% 的女性在产后 6 周出现 MDE，而对照组为 41%。我们发现产后 MDE（aOR = 0.19，95% CI 0.13-0.28）和中度至重度焦虑（aOR = 0.26，95% CI 0.17-0.40）的几率分别降低了 81% 和 74%。快乐母亲-健康婴儿计划早期产前干预重点关注焦虑症状，减少产后 CMD。 ClinicalTrials.gov 标识符 NCT03880032。