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Which antidepressants are best tolerated in primary care? A pilot randomized trial from goa.在基层医疗中哪种抗抑郁药的耐受性最好?来自果阿的一项试点随机试验。
Indian J Psychiatry. 1999 Oct;41(4):358-63.
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Integrating evidence-based treatments for common mental disorders in routine primary care: feasibility and acceptability of the MANAS intervention in Goa, India.在常规初级保健中整合常见精神障碍的循证治疗:印度果阿邦 MANAS 干预措施的可行性和可接受性。
World Psychiatry. 2008 Feb;7(1):39-46. doi: 10.1002/j.2051-5545.2008.tb00151.x.
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A simple approach to test for interaction between intervention and an individual-level variable in community randomized trials.一种在社区随机试验中检验干预与个体水平变量之间相互作用的简单方法。
Trop Med Int Health. 2008 Feb;13(2):247-55. doi: 10.1111/j.1365-3156.2007.01997.x.
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Prioritizing health problems in women in developing countries: comparing the financial burden of reproductive tract infections, anaemia and depressive disorders in a community survey in India.确定发展中国家女性的健康问题优先级:在印度的一项社区调查中比较生殖道感染、贫血和抑郁症的经济负担。
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Collaborative care for depression in primary care. Making sense of a complex intervention: systematic review and meta-regression.初级保健中抑郁症的协作护理。理解一项复杂干预措施:系统评价与元回归分析
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由非专业健康顾问主导的干预措施对印度果阿邦初级保健中抑郁和焦虑障碍的效果(MANAS):一项整群随机对照试验。

Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial.

机构信息

Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.

出版信息

Lancet. 2010 Dec 18;376(9758):2086-95. doi: 10.1016/S0140-6736(10)61508-5. Epub 2010 Dec 13.

DOI:10.1016/S0140-6736(10)61508-5
PMID:21159375
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4964905/
Abstract

BACKGROUND

Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders.

METHODS

In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems-10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407.

FINDINGS

24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00-1·47; risk difference=12·1%, 95% CI 1·6%-22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02-2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74-1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide.

INTERPRETATION

A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities.

FUNDING

The Wellcome Trust.

摘要

背景

抑郁和焦虑障碍是全球常见的精神障碍。MANAS 试验旨在测试由初级保健环境中的非专业健康顾问领导的干预措施对改善这些障碍患者结局的有效性。

方法

在这项整群随机试验中,印度果阿的初级保健机构按计算机生成的随机序列(1:1)分配到干预组或对照组(增强的常规护理)。所有筛查出常见精神障碍阳性的成年人都有资格参加。协作式分步护理干预提供了由经过培训的非专业健康顾问提供的病例管理和心理社会干预,由初级保健医生提供抗抑郁药物,并由心理健康专家进行监督。研究评估人员是盲法的。主要结局是根据国际疾病分类第十版(ICD-10)在 6 个月时从常见精神障碍中康复。这项研究在 ClinicalTrials.gov 注册,编号为 NCT00446407。

结果

24 个研究集群,公共和私人设施的比例相等,在两组之间平均随机分配。干预组中有 1360 名患者中的 1160 名(85%)和对照组中有 1436 名患者中的 1269 名(88%)完成了结局评估。在干预组中,经 ICD-10 确诊患有常见精神障碍的患者在 6 个月时更有可能康复(n=620 [65·0%] 与 n=553 [52·9%];风险比 1·22,95%CI 1·00-1·47;风险差异=12·1%,95%CI 1·6%-22·5%)。干预措施在公共设施就诊者中具有强有力的疗效证据(n=369 [65·9%] 与 n=267 [42·5%],风险比 1·55,95%CI 1·02-2·35),但在私人设施就诊者中没有证据表明有效(n=251 [64·1%] 与 n=286 [65·9%],风险比 0·95,0·74-1·22)。协作式分步护理组有 3 例死亡和 4 例自杀未遂,增强常规护理组有 6 例死亡和 6 例自杀未遂。没有一例死亡是自杀导致的。

解释

由经过培训的非专业健康顾问领导的合作式护理干预可以改善公共初级保健机构就诊患者的常见精神障碍康复情况。

资金来源

威康信托基金会。