AFFIRM RCT: task-sharing psychological intervention for perinatal depression

This is a meta-data file relating to the AFFIRM randomised controlled trial assessing the effectiveness of a task-shared psychological intervention for perinatal depression in Khayelitsha, South Africa, using non-specialist community health workers. A double-blind individual randomised controlled trial was conducted in two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town. Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS) were randomised into the intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls). The primary outcome was response on the Hamilton Depression Rating Scale (HDRS) at three months postpartum (minimum 40% score reduction from baseline) among participants who did not experience pregnancy or infant loss (modified intention-to-treat population) (registered on Clinical Trials: NCT01977326). Of 2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n=200; intervention: n=184). There were no significant differences in response on the HDRS at three months postpartum between the intervention and control arm. A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa. The findings give cause for reflection on the strategy of task-sharing in low-resource settings.Please see documents attached for more information on the AFFIRM randomised controlled trial and the questionnaire used. The data are available in SPSS, Stata or CSV files, and either in long or wide format. To access the data, please contact Prof Crick Lund: [e-mail]

本元数据文件关联于AFFIRM随机对照试验（randomised controlled trial），该试验旨在评估南非开普敦卡耶利特沙（Khayelitsha）地区由非专科社区卫生工作者开展的任务分享式心理干预针对围产期抑郁症的疗效。本研究采用双盲个体随机对照试验设计，在开普敦卡耶利特沙城郊定居点的两家产前诊所开展。凡爱丁堡产后抑郁量表（Edinburgh Postnatal Depression rating Scale, EPDS）得分≥13分的成年孕妇，被随机分配至干预组（接受结构化6次心理治疗）或对照组（仅接受常规产前保健及每月3次电话随访）。本研究的主要结局指标为：未发生妊娠或胎儿/婴儿失亡的受试者（改良意向治疗人群，modified intention-to-treat）在产后3个月时的汉密尔顿抑郁量表（Hamilton Depression Rating Scale, HDRS）应答情况，即较基线得分至少降低40%。该试验已在Clinical Trials平台注册（注册号：NCT01977326）。本研究共接触2187名符合纳入标准的女性，其中425名（19.4%）EPDS筛查结果呈阳性并被纳入随机分组；最终384名受试者被纳入改良意向治疗分析（对照组：n=200；干预组：n=184）。干预组与对照组受试者产后3个月的HDRS应答情况无显著统计学差异。研究表明，任务分享式心理治疗对于南非卡耶利特沙地区女性的抑郁症治疗并无显著疗效。本研究结果提示，需对低资源环境下的任务分享策略进行反思。如需了解AFFIRM随机对照试验及所用问卷的更多信息，请参阅附件文档。本数据集以SPSS、Stata或CSV格式提供，包含长格式与宽格式两种数据结构。如需获取数据，请联系Crick Lund教授：[e-mail]