Guided, internet-based, rumination-focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high-ruminating young adults, along with an adjunct assessment of the feasibility of unguided i-RFCBT, in the REducing Stress and Preventing Depression trial (RESPOND): study protocol for a phase III randomised controlled trial
Guided, internet-based, rumination-focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high-ruminating young adults, along with an adjunct assessment of the feasibility of unguided i-RFCBT, in the REducing Stress and Preventing Depression trial (RESPOND): study protocol for a phase III randomised controlled trial
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DOI：
10.1186/s13063-015-1128-9
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发表时间：
2016-01-04
期刊：
影响因子：
2.5
通讯作者：
Watkins, Edward
中科院分区：
文献类型：
--
作者：
Cook, Lorna;Watkins, Edward
背景：抑郁症是一个全球性的健康挑战。预防被强调为降低其流行率的优先事项。虽然存在有效的预防干预措施，但其效力和覆盖面还有待提高。一种提出的提高疗效的方法是使用干预措施来针对特定的风险因素，如反刍。反刍集中CBT（RFCBT）是专门针对抑郁性反刍而开发的，并在一项随机对照试验中减少残留抑郁症患者的急性抑郁症状和复发。荷兰一项随机预防试验的初步结果显示，在251名高风险的15至22岁的受试者中，选择的受试者具有较高的担忧和沉思，结果发现，相对于无干预对照组，支持互联网RFBCT和小组交付的RFCBT在1年内同样减少了抑郁症状和抑郁病例的发作。一项遵循医学研究理事会（MRC）复杂干预框架的III期随机对照试验将把一项荷兰试验扩展到英国，并增加诊断访谈，主要是为了测试引导互联网RFCBT是否相对于无干预对照减少抑郁症的发作。高风险的年轻人（年龄18至24岁），选择了升高的担忧/沉思，并通过大学和互联网广告招募，将随机接受指导互联网RFCBT，由临床心理学家或心理健康辅助专业人员支持，或无干预对照。作为辅助手段，参与者还被随机分配到无指导的互联网RFCBT自助，以提供这种干预的可行性和效果大小的初步测试。虽然参与者也被随机分配到无指导的互联网RFCBT，但该试验的设计和动力是III期试验，比较了有指导的互联网RFCBT与无干预对照。在这两个组之间的比较中，主要结局如下：a）在12个月期间的重度抑郁发作，在随机化后3个月（干预后）、6个月和15个月时通过结构化临床诊断访谈进行评估。将记录以下次要结局：广泛性焦虑障碍的发生率、抑郁和焦虑症状以及担忧和沉思水平，在基线和相同的随访间隔时测量。关于试点调查的无指导的互联网RFCBT（辅助干预臂），我们将评估的可行性和可接受的数据收集程序，水平的磨损，效果大小和可接受的无指导的互联网RFCBT intervention.Discussion：广泛实施是必要的有效预防，这表明，互联网可能是一个有价值的交付模式。以前的研究表明，引导互联网RFCBT相对于对照组降低了发病率。我们也有兴趣开发和评估一个无指导的版本，以提高可用性和降低成本。
Background: Depression is a global health challenge. Prevention is highlighted as a priority to reduce its prevalence. Although effective preventive interventions exist, the efficacy and coverage can be improved. One proposed means to increase efficacy is by using interventions to target specific risk factors, such as rumination. Rumination-focused CBT (RFCBT) was developed to specifically target depressive rumination and reduces acute depressive symptoms and relapse for patients with residual depression in a randomised controlled trial. Preliminary findings from a Dutch randomised prevention trial in 251 high-risk 15-to 22-year-old subjects selected with elevated worry and rumination found that both supported internet-RFBCT and group-delivered RFCBT equally reduced depressive symptoms and the onset of depressive cases over a period of 1 year, relative to the no-intervention control.Methods/Design: A phase III randomised controlled trial following the Medical Research Council (MRC) Complex Interventions Framework will extend a Dutch trial to the United Kingdom, with the addition of diagnostic interviews, primarily to test whether guided internet-RFCBT reduces the onset of depression relative to a no-intervention control. High-risk young adults (aged 18 to 24 years), selected with elevated worry/rumination and recruited through university and internet advertisement, will be randomised to receive either guided internet-RFCBT, supported by clinical psychologists or mental health paraprofessionals, or a no-intervention control. As an adjunct arm, participants are also randomised to unguided internet-RFCBT self-help to provide an initial test of the feasibility and effect size of this intervention. While participants are also randomised to unguided internet-RFCBT, the trial was designed and powered as a phase III trial comparing guided internet-RFCBT versus a no-intervention control. In the comparison between these two arms, the primary outcomes are as follows: a) onset of major depressive episode over a 12-month period, assessed with a Structured Clinical Interview for Diagnosis at 3 months (post-intervention), 6 months and 15 months after randomisation. The following secondary outcomes will be recorded: the incidence of generalized anxiety disorder, symptoms of depression and anxiety, and levels of worry and rumination, measured at baseline and at the same follow-up intervals. In relation to the pilot investigation of unguided internet-RFCBT (the adjunct intervention arm), we will assess the feasibility and acceptability of the data-collection procedures, levels of attrition, effect size and acceptability of the unguided internet-RFCBT intervention.Discussion: Widespread implementation is necessary for effective prevention, suggesting that the internet may be a valuable mode of delivery. Previous research suggests that guided internet-RFCBT reduces incidence rates relative to controls. We are also interested in developing and evaluating an unguided version to potentially increase the availability and reduce the costs.