Singla Daisy R, Silver Richard K, Vigod Simone N, Schoueri-Mychasiw Nour, Kim J Jo, La Porte Laura M, Ravitz Paula, Schiller Crystal E, Lawson Andrea S, Kiss Alex, Hollon Steven D, Dennis Cindy-Lee, Berenbaum Tara S, Krohn Holly A, Gibori Jamie E, Charlebois Jaime, Clark David M, Dalfen Ariel K, Davis Wendy, Gaynes Bradley N, Leszcz Molyn, Katz Sarah Rachel, Murphy Kellie E, Naslund John A, Reyes-Rodríguez Mae Lynn, Stuebe Alison M, Zlobin Claire, Mulsant Benoit H, Patel Vikram, Meltzer-Brody Samantha
Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Department of Psychiatry, Sinai Health, Toronto, Ontario, Canada.
Nat Med. 2025 Apr;31(4):1214-1224. doi: 10.1038/s41591-024-03482-w. Epub 2025 Mar 3.
Task-sharing and telemedicine can increase access to effective psychotherapies. Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) is pragmatic, multisite, noninferiority, four-arm trial that tested the non-inferiority of provider (non-specialist vs. specialist providers) and modality (telemedicine vs. in-person) in delivering psychotherapy for perinatal depressive symptoms. Across three university-affiliated networks in the United States and Canada, pregnant and postpartum adult participants were randomized 1:1:1:1 to each arm (472 nonspecialist telemedicine, 145 nonspecialist in-person, 469 specialist telemedicine and 144 specialist in-person) and offered weekly behavioral activation treatment sessions. The primary outcome was depressive symptoms (Edinburgh Postnatal Depression Scale (EPDS)) and the secondary outcome was anxiety (Generalized Anxiety Disorder (GAD-7)) symptoms at 3 months post-randomization. Between 8 January 2020 and 4 October 2023, 1,230 participants were recruited. Noninferiority was met for the primary outcome comparing provider (EPDS: nonspecialist 9.27 (95% CI 8.85-9.70) versus specialist 8.91 (95% CI 8.49-9.33)) and modality (EPDS: telemedicine 9.15 (95% CI 8.79-9.50) versus in-person 8.92 (95% CI 8.39-9.45)) for both intention-to-treat and per protocol analyses. Noninferiority was also met for anxiety symptoms in both comparisons. There were no serious or adverse events related to the trial. This trial suggests compelling evidence for task-sharing and telemedicine to improve access to psychotherapies for perinatal depressive and anxiety symptoms. ClinicalTrials.gov NCT04153864.
任务分担和远程医疗可以增加获得有效心理治疗的机会。通过增加治疗可及性来扩大孕产妇心理健康护理（SUMMIT）是一项务实的、多中心的、非劣效性、四臂试验，该试验测试了提供者（非专科医生与专科医生）和治疗方式（远程医疗与面对面治疗）在提供围产期抑郁症状心理治疗方面的非劣效性。在美国和加拿大的三个大学附属网络中，怀孕和产后的成年参与者被按1:1:1:1随机分配到每个组（472名非专科医生远程医疗组、145名非专科医生面对面治疗组、469名专科医生远程医疗组和144名专科医生面对面治疗组），并接受每周一次的行为激活治疗课程。主要结局是抑郁症状（爱丁堡产后抑郁量表（EPDS）），次要结局是随机分组后3个月时的焦虑症状（广泛性焦虑障碍（GAD - 7））。在2020年1月8日至2023年10月4日期间，招募了1230名参与者。在意向性分析和符合方案分析中，主要结局在比较提供者（EPDS：非专科医生9.27（95%可信区间8.85 - 9.70）与专科医生8.91（95%可信区间8.49 - 9.33））和治疗方式（EPDS：远程医疗9.15（95%可信区间8.79 - 9.50）与面对面治疗8.92（95%可信区间8.39 - 9.45））时均达到非劣效性。在两项比较中，焦虑症状也达到了非劣效性。没有与试验相关的严重或不良事件。该试验为任务分担和远程医疗改善围产期抑郁和焦虑症状心理治疗的可及性提供了有力证据。ClinicalTrials.gov标识符：NCT04153864。
