Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine.
Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine.
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DOI：
10.1002/hup.2543
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发表时间：
2016-07
期刊：
影响因子：
--
通讯作者：
Bishop FL
中科院分区：
文献类型：
--
作者：
Kwakye IN;Garner M;Baldwin DS;Bamford S;Pinkney V;Bishop FL
本研究的目的是深入了解健康志愿者的精神健康试验经历。一项定性研究嵌套在度洛西汀的健康志愿者安慰剂对照试验中，度洛西汀是一种用于治疗重度抑郁症和广泛性焦虑症患者的精神药物。八名参与者进行了采访，并使用解释现象学分析的数据进行了分析。受访者描述志愿参加试验是因为他们对研究感兴趣，想要金钱激励，想要帮助研究人员，并且想要成为某件事的一部分。在进入试验时，参与者考虑了可能的风险，并描述了感到焦虑，兴奋和决心;他们有一些明确的期望和一些松散的希望会发生什么。在试验过程中，参与者对自己是否服用度洛西汀或安慰剂感到好奇，自我监测身体的反应，并猜测自己接受了哪种治疗。在完成试验后对治疗分配进行揭盲时，一些参与者的猜测得到了证实，但其他人感到惊讶，少数人感到失望。对广告/知情同意书材料进行小幅修改以反映志愿者的动机，可以提高类似试验的招募率;“活性”安慰剂可能对健康志愿者试验中的盲态保持特别有用;需要敏感的程序来揭盲受试者的治疗分配。版权所有2016作者.《人类精神药理学：临床与实验》（Human Psychopharmacology：Clinical and Experimental），John Wiley & Sons，Ltd出版。
The objective of this study was to develop an in‐depth understanding of healthy volunteers' experiences of mental health trials. A qualitative study was nested within a healthy volunteer placebo‐controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis. Interviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self‐monitored their bodies' reactions, and guessed which treatment they received. On being un‐blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed. Small changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; “active” placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un‐blinding participants to treatment allocation. © 2016 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons, Ltd.
影响因子：
4.1
作者：
Dunlop BW;Banja J
通讯作者：
Banja J