Almeida Osvaldo P, MacLeod Colin, Ford Andrew, Grafton Ben, Hirani Varsha, Glance David, Holmes Emily
Western Australian Centre for Health & Ageing (M573), Centre for Medical Research of the Perkins Institute for Medical Research, University of Western Australia, 35 Stirling Highway, Crawley, WA 6009, Australia.
Trials. 2014 Jul 11;15:282. doi: 10.1186/1745-6215-15-282.
Depression is a leading cause of disability worldwide and, although efficacious treatments are available, their efficacy is suboptimal and recurrence of symptoms is common. Effective preventive strategies could reduce disability and the long term social and health complications associated with the disorder, but current options are limited. Cognitive bias modification (CBM) is a novel, simple, and safe intervention that addresses attentional and interpretive biases associated with anxiety, dysphoria, and depression. The primary aim of this trial is to determine if CBM decreases the one-year onset of a major depressive episode among adults with subsyndromal depression.
This randomised controlled trial will recruit 532 adults with subsyndromal symptoms of depression living in the Australian community (parallel design, 1:1 allocation ratio). Participants will be free of clinically significant symptoms of depression and of psychotic disorders, sensory and cognitive impairment, and risky alcohol use. The CBM intervention will target attentional and interpretive biases associated with depressive symptoms. The sessions will be delivered via the internet over a period of 52 weeks. The primary outcome of interest is the onset of a major depressive episode according the DSM-IV-TR criteria over a 12-month period. Secondary outcomes of interest include change in the severity of depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9), use of antidepressants or benzodiazepines, and changes in attention and interpretive biases. The assessment of outcomes will take place 3, 6, 9, and 12 months after randomisation and will occur via the internet.
We propose to test the efficacy of an innovative intervention that is well grounded in theory and for which increasing empirical evidence for an effect on mood is available. The intervention is simple, inexpensive, easy to access, and could be easily rolled out into practice if our findings confirm a role for CBM in the prevention of depression.
Australian and New Zealand Clinical Trials Registry ACTRN12613001334796. Date: 5th December 2013.
抑郁症是全球致残的主要原因，尽管有有效的治疗方法，但疗效并不理想，症状复发很常见。有效的预防策略可以减少残疾以及与该疾病相关的长期社会和健康并发症，但目前的选择有限。认知偏差矫正（CBM）是一种新颖、简单且安全的干预措施，可解决与焦虑、烦躁和抑郁相关的注意力和解释偏差。本试验的主要目的是确定CBM是否能降低亚综合征性抑郁症成年人中重度抑郁发作的一年发病率。
这项随机对照试验将招募532名居住在澳大利亚社区且有亚综合征性抑郁症状的成年人（平行设计，分配比例为1:1）。参与者将没有临床上显著的抑郁症状、精神障碍、感觉和认知障碍以及危险饮酒行为。CBM干预将针对与抑郁症状相关的注意力和解释偏差。课程将在52周内通过互联网进行。感兴趣的主要结局是根据《精神疾病诊断与统计手册》第四版修订版（DSM-IV-TR）标准在12个月内出现重度抑郁发作。感兴趣的次要结局包括用患者健康问卷（PHQ-9）测量的抑郁症状严重程度的变化、抗抑郁药或苯二氮䓬类药物的使用情况以及注意力和解释偏差的变化。结局评估将在随机分组后3、6、9和12个月通过互联网进行。
我们提议测试一种基于理论且有越来越多实证证据表明其对情绪有影响的创新干预措施的疗效。该干预措施简单、廉价、易于实施，如果我们的研究结果证实CBM在预防抑郁症方面的作用，它可以很容易地推广到实际应用中。
澳大利亚和新西兰临床试验注册中心ACTRN12613001334796。日期：2013年12月5日。
