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.
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.
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DOI：
10.1016/s0140-6736(10)61508-5
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发表时间：
2010-12-18
期刊：
影响因子：
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通讯作者：
Kirkwood BR
中科院分区：
文献类型：
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作者：
Patel V;Weiss HA;Chowdhary N;Naik S;Pednekar S;Chatterjee S;De Silva MJ;Bhat B;Araya R;King M;Simon G;Verdeli H;Kirkwood BR
发展中国家改善抑郁症和焦虑症（常见精神障碍）护理的挑战之一是缺乏熟练的人力资源和缺乏心理社会干预措施。实施MANAS试验是为了测试在初级卫生保健环境中由非专业卫生工作者领导的干预措施对改善印度果阿CMD患者结局的有效性。以初级保健机构作为随机化单位的整群随机试验。24个初级保健设施，与公共初级卫生中心（PHC）和私人全科医生（GP）的做法相同的比例，被随机分配到预先定义的阶层，干预（协作阶梯式护理，CSC）或控制（增强常规护理，EUC）组。使用一般健康问卷对所有在设施中出现的成年人进行CMD筛查，得分高于5分的人被视为有资格参加试验。社区服务中心提供病例管理和心理社会干预，由一名受过培训的非专业健康顾问提供，由初级保健医生提供抗抑郁药物，并由一名来访的心理健康专家进行监督。主要结局是招募后6个月从ICD-10定义的CMD中恢复。次要结局是抑郁和焦虑症状的严重程度。次要分析按设施类型（公共vs私人）分层。招募了2796例（合格人群的81%）（CSC组1360例，EUC组1436例），其中1160例（85%）和1269例（88%）分别在6个月的主要终点完成了结局评价。干预组中ICD-10明确CMD的患者更有可能在6个月时恢复（65% vs 53%;风险比=1.22，95%CI 1.00-1.47;风险差= 12%，95%CI 2%-23%）。二次分析表明，干预措施有一个普遍的强大和一致的效果，在PHC设施出席，但不是GP设施出席所有诊断组除了抑郁症，没有效果被发现。MANAS试验是最大的有效性试验的初级保健为基础的干预措施，以整合CMD治疗到常规的初级保健在发展中国家。该试验表明，由训练有素的非专业顾问领导的干预措施可以改善CMD的恢复，特别是在那些参加初级卫生保健设施的人中。MANAS项目已在美国国立卫生研究院申办的临床试验登记处注册，并已分配标识符：NCT 00446407
Amongst the challenges to improving care for depressive and anxiety disorders (the common mental disorders, CMD) in developing countries are the shortage of skilled human resources and the lack of availability of psychosocial interventions. The MANAS trial was implemented to test the effectiveness of a lay health worker led intervention in primary health care settings to improve outcomes of people with CMD in Goa, India. Cluster randomised trial with primary care facility as unit of randomisation. Twenty-four primary care facilities, with an equal proportion of public Primary Health Centres (PHC) and private General Practitioners (GP) practices, were randomly allocated within pre-defined strata, to intervention (collaborative stepped care, CSC) or control (enhanced usual care, EUC) groups. All adults presenting at a facility were screened for CMD with the General Health Questionnaire and those scoring above a cut-off point of five were regarded as eligible for participation in the trial. The CSC arm provided case management and psychosocial interventions, delivered by a trained Lay Health Counsellor, antidepressant medication by the primary care physician and supervision by a visiting mental health specialist. The primary outcome was recovery from ICD-10 defined CMD six months after recruitment. The secondary outcome was the severity of symptoms of depression and anxiety. Secondary analyses were stratified by facility type (public vs private). 2796 (81% of the eligible population) were recruited (1360 in the CSC arm and 1436 in the EUC arm), of whom 1160 (85%) and 1269 (88%) respectively completed the outcome evaluation at the primary end-point of six months. Patients with ICD-10 definite CMD in the intervention arm were more likely to have recovered at 6 months (65% vs 53%; risk ratio=1.22, 95%CI 1.00–1.47; risk difference=12%, 95%CI 2%-23%). Secondary analyses showed that the intervention had a generally strong and consistent effect in PHC facility attenders but not GP facility attenders for all diagnostic groups apart from depression where no effect was found. The MANAS trial is the largest effectiveness trial of a primary-care based intervention to integrate CMD treatments into routine primary care in a developing country. The trial demonstrates that an intervention led by a trained lay counsellor improves recovery from CMD, in particular among those attending primary health care facilities. The MANAS project was registered with the National Institutes of Health sponsored clinical trials registry and has been assigned the identifier: NCT00446407