A randomised, controlled trial of a dietary intervention for adults with major depression (the "SMILES" trial): study protocol.
A randomised, controlled trial of a dietary intervention for adults with major depression (the "SMILES" trial): study protocol.
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DOI：
10.1186/1471-244x-13-114
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发表时间：
2013-04-15
期刊：
影响因子：
4.4
通讯作者：
Jacka FN
中科院分区：
文献类型：
--
作者：
O'Neil A;Berk M;Itsiopoulos C;Castle D;Opie R;Pizzinga J;Brazionis L;Hodge A;Mihalopoulos C;Chatterton ML;Dean OM;Jacka FN
尽管在识别和治疗抑郁症方面的投资有所增加，但抑郁症仍然是世界范围内一个重大的健康和经济负担。目前的治疗策略一般侧重于生物和心理途径，很大程度上忽视了生活方式的作用。越来越多的证据表明，饮食和营养在抑郁症的发病和风险中起着重要作用。然而，关于饮食改变对现有精神疾病的治疗影响的数据有限。采用随机对照试验设计，我们旨在研究饮食方案治疗重度抑郁发作（MDE）的疗效和成本效益。176名患有当前MDE的符合条件的参与者被随机分为饮食干预组或社会支持组。使用Montgomery -Åsberg抑郁评定量表（MADRS）和《精神障碍诊断与统计手册（非患者版）》（SCID-I/NP）结构化临床访谈来评估抑郁状态。干预包括7个单独的营养咨询会议（约60分钟），由认可执业营养师（APD）提供。课程在基线评估后一周内开始。干预措施的重点是倡导以《澳大利亚膳食指南》和《希腊成人膳食指南》为基础的健康饮食。控制条件包括一个友好协议，使用与饮食干预相同的访问时间表和时间。这项研究是在澳大利亚维多利亚州的两个地点进行的（一个大都市和区域中心）。数据收集发生在基线（干预前）、3个月（干预后）和6个月。主要终点是3个月时的MADRS评分。成本后果分析将决定干预措施的经济价值。如果有效，该项目可以为这种高度流行的精神障碍的管理提供一种替代或辅助治疗策略；其益处可以扩展到常见合并症的管理，包括心血管疾病（CVD）、肥胖和2型糖尿病。NCT01523561
Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE). One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6– months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention. If efficacious, this program could provide an alternative or adjunct treatment strategy for the management of this highly prevalent mental disorder; the benefits of which could extend to the management of common co-morbidities including cardiovascular disease (CVD), obesity, and type 2 diabetes. NCT01523561