Schakel Lemmy, Veldhuijzen Dieuwke S, van Middendorp Henriët, Prins Corine, Joosten Simone A, Ottenhoff Tom H M, Visser Leo G, Evers Andrea W M
Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden University, PO Box 9555, 2300 RB, Leiden, The Netherlands.
Leiden Institute for Brain and Cognition, Leiden University, Leiden, The Netherlands.
Trials. 2017 May 26;18(1):243. doi: 10.1186/s13063-017-1983-7.
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.
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.
Nederlands Trial Register, NTR5610 . Registered on 4 January 2016.
先前的研究已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，如面对面或在线认知行为疗法（CBT）以及旨在改善健康的严肃游戏，在促进健康结果方面已显示出有前景的结果。然而，到目前为止，很少有研究考察基于互联网的CBT结合严肃游戏元素是否能有效调节健康结果。此外，研究通常未纳入心理生理或免疫挑战，以便深入了解心理干预后对现实生活挑战的生理反应。本研究的总体目标是调查一种心理干预对免疫和心理生理挑战下自我报告的健康结果和生理健康结果的影响。
方法/设计：在一项随机对照试验中，60名健康男性被随机分配到实验条件组，接受为期6周的基于互联网的（电子健康）引导式CBT并结合与健康相关的严肃游戏元素，或分配到不接受干预的对照组。心理干预后，测量自我报告的活力，并以卡介苗（BCG）接种的形式对参与者进行免疫挑战。接种疫苗一天后，要求参与者执行多项心理生理任务，以探究心理干预对免疫挑战后参与者应激反应的影响。为评估疫苗接种对自我报告的健康结果和生理健康结果的延迟影响，计划在4周后进行随访。研究总时长约为14周。主要结局指标是干预后直接测量的自我报告活力。次要结局指标包括炎症和内分泌标志物，以及卡介苗接种后对心理生理任务的心率和皮肤电导率的心理生理测量。
本研究的创新设计特点——例如，将引导式电子健康CBT与与健康相关的严肃游戏元素相结合，并纳入免疫和心理生理挑战——将为心理干预对自我报告的健康结果和生理健康结果的影响提供有价值的信息。本研究将进一步深入了解心理因素与健康结果之间联系的潜在机制，并有望为优化医疗保健策略做出贡献。
荷兰试验注册库，NTR5610。于2016年1月4日注册。
