Murphy Jill, Goldsmith Charles H, Jones Wayne, Oanh Pham Thi, Nguyen Vu Cong
Centre for Applied Research in Mental Health and Addictions, Simon Fraser University, Suite 2400, 515 W. Hastings Street, Vancouver, BC, V6B 5K3, Canada.
Faculty of Health Sciences, Simon Fraser University, Blusson Hall, Room 11300, 8888 University Drive, Burnaby, BC, V5A 1S6, Canada.
Trials. 2017 May 5;18(1):209. doi: 10.1186/s13063-017-1924-5.
Depressive disorders are one of the leading causes of disease and disability worldwide. In Vietnam, although epidemiological evidence suggests that depression rates are on par with global averages, services for depression are very limited. In a feasibility study that was implemented from 2013 to 2015, we found that a Supported Self-management (SSM) intervention showed promising results for adults with depression in the community in Vietnam. This paper describes the Mental Health in Adults and Children: Frugal Innovations (MAC-FI) trial protocol that will assess the effectiveness of the SSM intervention, delivered by primary care and social workers, to community-based populations of adults with depression in eight Vietnamese provinces.
METHODS/DESIGN: The MAC-FI program will be assessed using a stepped-wedge, randomized controlled trial. Study participants are adults aged 18 years and over in eight provinces of Vietnam. Study participants will be screened at primary care centres and in the community by health and social workers using the Self-reporting Questionnaire-20 (SRQ-20). Patients scoring >7, indicating depression caseness, will be invited to participate in the study in either the SSM intervention group or the enhanced treatment as usual control group. Recruited participants will be further assessed using the World Health Organization's Disability Assessment Scale (WHODAS 2.0) and the Cut-down, Annoyed, Guilty, Eye-opener (CAGE) Questionnaire for alcohol misuse. Intervention-group participants will receive the SSM intervention, delivered with the support of a social worker or social collaborator, for a period of 2 months. Control- group participants will receive treatment as usual and a leaflet with information about depression. SRQ-20, WHODAS 2.0 and CAGE scores will be taken by blinded outcome assessors at baseline, after 1 month and after 2 months. The primary analysis method will be intention-to-treat.
This study has the potential to add to the knowledge base about the effectiveness of a SSM intervention for adult depression that has been validated for the Vietnamese context. This trial will also contribute to the growing body of evidence about the effectiveness of low-cost, task-shifting interventions for use in low-resource settings, where specialist mental health services are often limited.
Retrospectively registered at ClinicalTrials.gov, identifier: NCT03001063 . Registered on 20 December 2016.
抑郁症是全球疾病和残疾的主要原因之一。在越南，尽管流行病学证据表明抑郁症发病率与全球平均水平相当，但抑郁症服务却非常有限。在2013年至2015年实施的一项可行性研究中，我们发现支持性自我管理（SSM）干预措施对越南社区中的成年抑郁症患者显示出了有前景的结果。本文描述了成人及儿童心理健康：节俭创新（MAC-FI）试验方案，该方案将评估由初级保健人员和社会工作者提供的SSM干预措施对越南八个省份社区成年抑郁症患者群体的有效性。
方法/设计：MAC-FI项目将采用阶梯式楔形随机对照试验进行评估。研究参与者为越南八个省份18岁及以上的成年人。研究参与者将在初级保健中心和社区由卫生和社会工作者使用自评问卷20（SRQ-20）进行筛查。得分>7（表明为抑郁症患者）的患者将被邀请参加SSM干预组或强化常规治疗对照组的研究。招募的参与者将使用世界卫生组织残疾评估量表（WHODAS 2.0）和用于评估酒精滥用的简版密歇根酒精筛查测试（CAGE）问卷进行进一步评估。干预组参与者将在社会工作者或社会协作者的支持下接受为期2个月的SSM干预。对照组参与者将接受常规治疗并收到一份有关抑郁症的宣传册。SRQ-20、WHODAS 2.0和CAGE得分将由盲法结局评估者在基线、1个月后和2个月后获取。主要分析方法将是意向性分析。
本研究有可能增加关于已在越南背景下得到验证的SSM干预措施对成人抑郁症有效性的知识库。该试验还将为越来越多关于在资源匮乏地区使用低成本、任务转移干预措施有效性的证据做出贡献，在这些地区，专业心理健康服务往往有限。
在ClinicalTrials.gov上进行追溯注册，标识符：NCT03001063。于2016年12月20日注册。
