Rahman Atif, Malik Abid, Nazir Huma, Zaidi Ahmed, Nisar Anum, Waqas Ahmed, Atif Najia, Gibbs Naomi Kate, Luo Yutian, Sikander Siham, Wang Duolao
Institute of Population Health, University of Liverpool, Liverpool, UK.
Department of Public Mental Health, Health Services Academy, Islamabad, Pakistan.
Nat Med. 2025 Apr 8. doi: 10.1038/s41591-025-03655-1.
Perinatal depression affects one in four women in low- and middle-income countries. The World Health Organization's Thinking Healthy Programme (WHO-THP) is an established 'task-shared' cognitive-behavioral therapy intervention for perinatal depression. However, efforts to scale up are hampered by overburdened health systems struggling to maintain quality and fidelity. Here, to overcome these challenges, we coproduced with end users a technology-assisted digital version of the THP delivered by lived-experience peers (technology-assisted peer-delivered THP (THP-TAP)). We aimed to evaluate the effectiveness of THP-TAP compared to the established WHO-THP. A single-blind cluster-randomized controlled noninferiority trial was conducted in rural Rawalpindi, Pakistan, with 70 village clusters randomly distributed to the two interventions. From June 2022 to May 2023, we recruited 980 women with perinatal depression registered with primary healthcare centers. The primary outcome was remission from the depressive episode at 3 months postnatal. On assessment of 846/980 (86.3%) participants at 3 months postnatal, the difference in the remission rate was 8.91% with the lower boundary of the one-sided 97.5% confidence interval being 4.25%, larger than the prespecified -10% noninferiority margin (P < 0.0001). In settings where health systems are weak and overburdened, THP-TAP offers an effective and potentially scalable alternative to the delivery of psychosocial interventions. ClinicalTrials.gov registration: NCT05353491 .
在低收入和中等收入国家，四分之一的女性会受到围产期抑郁症的影响。世界卫生组织的“健康思考计划”（WHO-THP）是一种既定的针对围产期抑郁症的“任务分担”认知行为疗法干预措施。然而，由于卫生系统负担过重，难以维持质量和保真度，扩大规模的努力受到了阻碍。在此，为了克服这些挑战，我们与最终用户共同制作了一个由有生活经验的同伴提供的技术辅助数字版THP（技术辅助同伴提供的THP（THP-TAP））。我们旨在评估THP-TAP与既定的WHO-THP相比的有效性。在巴基斯坦拉瓦尔品第农村地区进行了一项单盲整群随机对照非劣效性试验，将70个村庄整群随机分配到两种干预措施中。从2022年6月到2023年5月，我们招募了980名在初级医疗保健中心登记的围产期抑郁症女性。主要结局是产后3个月时抑郁发作缓解。在产后3个月对846/980（86.3%）名参与者进行评估时，缓解率差异为8.91%，单侧97.5%置信区间的下限为4.25%，大于预先设定的-10%非劣效性界值（P < 0.0001）。在卫生系统薄弱且负担过重的环境中，THP-TAP为提供心理社会干预提供了一种有效且可能可扩展的替代方案。ClinicalTrials.gov注册号：NCT05353491 。
