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The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial

机译：针对优化免疫功能的心理干预的效果：一项随机对照试验的研究方案

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Background Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral therapy (CBT) and serious games aimed at improving health, have shown promising results in promoting health outcomes. Few studies so far, however, have examined whether Internet-based CBT combined with serious gaming elements is effective in modulating health outcomes. Moreover, studies often did not incorporate psychophysiological or immunological challenges in order to gain insight into physiological responses to real-life challenges after psychological interventions. The overall aim of this study is to investigate the effects of a psychological intervention on self-reported and physiological health outcomes in response to immune and psychophysiological challenges. Methods/design In a randomized controlled trial, 60 healthy men are randomly assigned to either an experimental condition, receiving guided Internet-based (e-health) CBT combined with health-related serious gaming elements for 6?weeks, or a control condition receiving no intervention. After the psychological intervention, self-reported vitality is measured, and participants are given an immunological challenge in the form of a Mycobacterium bovis Bacillus Calmette-Guérin (BCG) vaccination. One day after the vaccination, participants are asked to perform several psychophysiological tasks in order to explore the effects of the psychological intervention on participants’ stress response following the immune challenge. To assess the delayed effects of vaccination on self-reported and physiological health outcomes, a follow-up visit is planned 4?weeks later. Total study duration is approximately 14?weeks. The primary outcome measure is self-reported vitality measured directly after the intervention. Secondary outcome measures include inflammatory and endocrine markers, as well as psychophysiological measures of heart rate and skin conductance in response to the psychophysiological tasks after the BCG vaccination. Discussion The innovative design features of this study – e.g., combining guided e-health CBT with health-related serious gaming elements and incorporating immunological and psychophysiological challenges – will provide valuable information on the effects of a psychological intervention on both self-reported and physiological health outcomes. This study will offer further insights into the mechanisms underlying the link between psychological factors and health outcomes and is anticipated to contribute to the optimization of health care strategies. Trial registration Nederlands Trial Register, NTR5610 . Registered on 4 January 2016.
机译：背景技术先前的研究为心理过程与心理生理健康结果之间的联系提供了证据。心理干预，例如面对面或在线认知行为疗法（CBT）以及旨在改善健康状况的严肃游戏，已显示出在促进健康结果方面的可喜结果。但是，到目前为止，很少有研究检查基于Internet的CBT与严肃的游戏元素相结合是否对调节健康结果有效。此外，为了获得对心理干预后对现实生活挑战的生理反应的深入了解，研究通常没有纳入心理生理学或免疫学挑战。这项研究的总体目标是调查心理干预对自我报告和生理健康结果的影响，以应对免疫和心理生理方面的挑战。方法/设计在一项随机对照试验中，将60名健康男性随机分配到一种实验条件下，接受为期6周的基于互联网的指导性（e-health）CBT结合健康相关的严重游戏元素，或接受一种控制条件没有干预。在进行心理干预之后，将测量自我报告的生命力，并以牛分枝杆菌卡介苗（BCG）疫苗的形式对参与者进行免疫挑战。接种疫苗后的一天，要求参与者执行一些心理生理任务，以探讨心理干预对免疫挑战后参与者的应激反应的影响。为了评估疫苗接种对自我报告和生理健康结果的延迟影响，计划在4周后进行一次随访。总学习时间约为14周。主要结果指标是干预后直接测量的自我报告的活力。次要结果指标包括炎症和内分泌标志物，以及对BCG疫苗接种后的心理生理任务做出反应的心率和皮肤电导率的心理生理指标。讨论这项研究的创新设计功能-例如，将指导性电子保健CBT与健康相关的严重游戏元素相结合，并纳入免疫和心理生理方面的挑战-将提供有关心理干预对自我报告和生理健康的影响的有价值的信息结果。这项研究将提供有关心理因素与健康结果之间联系的潜在机制的进一步见解，并有望有助于优化卫生保健策略。试用注册Nederlands试用注册，NTR5610。 2016年1月4日注册。

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