The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials
The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials
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DOI：
10.1186/s13063-015-1063-9
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发表时间：
2015-11-25
期刊：
影响因子：
2.5
通讯作者：
Patel, Vikram
中科院分区：
文献类型：
--
作者：
Sikander, Siham;Lazarus, Anisha;Patel, Vikram
背景：南亚的围产期抑郁症（产前和产后抑郁症）发病率是世界上最高的。由于缺乏人力资源，通过现有卫生系统为围产期抑郁症提供有效的心理治疗是一项挑战。本文报告了一项试验方案，旨在评估同伴提供的健康思考方案（健康思考方案同伴提供；THPP）对巴基斯坦和印度农村和城市环境中患有中度至重度围产期抑郁症的妇女的有效性和成本效益。方法/设计：通过两项随机对照试验对THPP进行评估：一项是在巴基斯坦拉瓦尔品第进行的集群试验，另一项是在印度果阿进行的单独随机试验。试验参与者是在巴基斯坦研究地区的女性保健工作者处登记的孕妇，以及在印度产前门诊诊所就诊的孕妇。他们将使用患者健康问卷-9 （PHQ-9）对抑郁症状进行筛选，如果他们的PHQ-9等于或大于10 (PHQ-9 >= 10)，他们将符合条件。样本量将分别为巴基斯坦和印度的560名和280名妇女。干预部门（THPP）的妇女将获得10次个人和4次小组会议（巴基斯坦）或6-14次个人会议（印度），由同伴（定义为来自同一社区的母亲，在提供干预方面接受培训和监督）提供。控制组的妇女（加强常规护理）将像往常一样获得保健服务，通过向妇科医生或初级保健设施提供经修订的世卫组织mhGAP抑郁症治疗指南，并向妇女提供诊断和如何为自己寻求帮助的信息，从而得到加强。主要结局是产后6个月随访时抑郁症状的缓解和严重程度。次要结局包括产后随访3个月时抑郁症状的缓解和严重程度、功能残疾、感知到的社会支持、母乳喂养率、婴儿身高和体重以及产后随访3个月和6个月时的医疗保健费用。主要的分析将是意向治疗。讨论：这些试验有可能加强证据的有效性和成本效益的循证心理治疗由世界卫生组织推荐和同行提供围产期抑郁症。这些试验具有克服全球精神卫生人力资源短缺的独特机会，并可能促进我们对在资源匮乏环境中利用与现有卫生系统合作的同伴的理解。
Background: Rates of perinatal depression (antenatal and postnatal depression) in South Asia are among the highest in the world. The delivery of effective psychological treatments for perinatal depression through existing health systems is a challenge due to a lack of human resources. This paper reports on a trial protocol that aims to evaluate the effectiveness and cost-effectiveness of the Thinking Healthy Programme delivered by peers (Thinking Healthy Programme Peer-delivered; THPP), for women with moderate to severe perinatal depression in rural and urban settings in Pakistan and India.Methods/Design: THPP is evaluated with two randomised controlled trials: a cluster trial in Rawalpindi, Pakistan, and an individually randomised trial in Goa, India. Trial participants are pregnant women who are registered with the lady health workers in the study area in Pakistan and pregnant women attending outpatient antenatal clinics in India. They will be screened using the patient health questionnaire-9 (PHQ-9) for depression symptoms and will be eligible if their PHQ-9 is equal to or greater than 10 (PHQ-9 >= 10). The sample size will be 560 and 280 women in Pakistan and India, respectively. Women in the intervention arm (THPP) will be offered ten individual and four group sessions (Pakistan) or 6-14 individual sessions (India) delivered by a peer (defined as a mother from the same community who is trained and supervised in delivering the intervention). Women in the control arm (enhanced usual care) will receive health care as usual, enhanced by providing the gynaecologist or primary-health facilities with adapted WHO mhGAP guidelines for depression treatment, and providing the woman with her diagnosis and information on how to seek help for herself. The primary outcomes are remission and severity of depression symptoms at the 6-month postnatal follow-up. Secondary outcomes include remission and severity of depression symptoms at the 3-month postnatal follow-up, functional disability, perceived social support, breastfeeding rates, infant height and weight, and costs of health care at the 3- and 6-month postnatal follow-ups. The primary analysis will be intention-to-treat.Discussion: The trials have the potential to strengthen the evidence on the effectiveness and cost-effectiveness of an evidence-based psychological treatment recommended by the World Health Organisation and delivered by peers for perinatal depression. The trials have the unique opportunity to overcome the shortage of human resources in global mental health and may advance our understanding about the use of peers who work in partnership with the existing health systems in low-resource settings.