Expanding care for perinatal women with depression (EXPONATE): study protocol for a randomized controlled trial of an intervention package for perinatal depression in primary care
Expanding care for perinatal women with depression (EXPONATE): study protocol for a randomized controlled trial of an intervention package for perinatal depression in primary care
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DOI：
10.1186/s12888-015-0537-3
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发表时间：
2015-06-30
期刊：
影响因子：
4.4
通讯作者：
Groleau, Danielle
中科院分区：
文献类型：
--
作者：
Gureje, Oye;Oladeji, Bibilola Damilola;Groleau, Danielle
背景：抑郁症在围产期妇女中很常见，并与母亲和婴儿的长期不良后果有关。在尼日利亚，与许多其他低收入和中等收入国家一样，围产期抑郁症通常未被发现和治疗。expate的目的是测试社区助产士在初级孕产妇保健中提供的围产期抑郁症干预包的有效性和成本效益，其中医生支持和提高患者依从性是通过移动电话实施的。方法/研究设计：设计实用的双臂平行群随机对照试验。分配单位是初级产妇保健诊所。30家符合条件且同意的诊所被随机分配，但由于后勤问题，最终有29家诊所参与。在爱丁堡产后抑郁量表（EPDS评分>= 12）中筛选为阳性，无精神病或双相情感障碍，且没有主动自杀的孕龄在16至28周之间的孕妇被招募到试验中（N = 686）。干预组的助产士接受了提供心理教育、解决问题治疗和育儿技能的培训。进入研究后，每周进行8次治疗。怀孕期间和分娩后6周的进一步疗程由抑郁症状水平决定。临床支持和监督主要由普通医生和精神科医生通过移动电话提供。自动文本和语音信息，也通过手机发送，用于促进患者遵守诊所预约和“家庭作业”任务。控制组的患者通过对该组的医生进行进一步的培训，在抑郁症的识别和标准治疗方面得到了照护。在基线、入组后2个月以及分娩后3、6、9和12个月进行评估。主要终点是6个月时从抑郁中恢复（EPDS < 6）。次要结果包括残疾、养育技能、母亲态度、保健利用以及使用贝利量表综合评估的婴儿身体和认知发展的措施。讨论：据我们所知，这是撒哈拉以南非洲地区社区助产士提供一揽子干预措施的最大的随机对照试验。
Background: Depression is common among women during perinatal period and is associated with long-term adverse consequences for the mother and infant. In Nigeria, as in many other low- and-middle-income countries (LMIC), perinatal depression usually goes unrecognized and untreated. The aim of EXPONATE is to test the effectiveness and cost-effectiveness of an intervention package for perinatal depression delivered by community midwives in primary maternal care in which physician support and enhanced patient compliance are implemented using mobile phones.Methods/Study design: A pragmatic two-arm parallel cluster randomized controlled trial was designed. The units of allocation are the primary maternal care clinics. Thirty eligible and consenting clinics were randomized but, due to problems with logistics, 29 eventually participated. Consenting pregnant women with a gestational age between 16 and 28 weeks who screened positive on the Edinburgh Postnatal Depression Scale (EPDS score >= 12), absent psychosis or bipolar disorder, and not actively suicidal were recruited into the trial (N = 686). Midwives in the intervention arm were trained to deliver psychoeducation, problem solving treatment, and parenting skills. Eight weekly sessions were delivered following entry into the study. Further sessions during pregnancy and 6 weeks following childbirth were determined by level of depressive symptoms. Clinical support and supervision, delivered mainly by mobile phone, were provided by general physicians and psychiatrists. Automated text and voice messages, also delivered by mobile phones, were used to facilitate patient compliance with clinic appointments and 'homework' tasks. Patients in the control arm received care as usual enhanced by further training of the providers in that arm in the recognition and standard treatment of depression. Assessments are undertaken at baseline, 2 months following recruitment into the study and 3, 6, 9 and 12 months after childbirth. The primary outcome is recovery from depression (EPDS < 6) at 6 months. Secondary outcomes include measures of disability, parenting skills, maternal attitudes, health care utilization as well as infant physical and cognitive development comprehensively assessed using the Bayley's Scales.Discussion: To the best of our knowledge, this is the largest randomized controlled trial of an intervention package delivered by community midwives in sub-Saharan Africa.