Abstract
BackgroundPrevious 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/designIn 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.DiscussionThe 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 registrationNederlands Trial Register, NTR5610. Registered on 4 January 2016.
Highlights
Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes
The present study evaluates whether self-reported and physiological health outcomes can be modulated by a psychological intervention directed at optimizing immune function
The intervention consists of guided ehealth cognitive behavioral therapy (CBT) in combination with health-related serious gaming elements and will be tested in healthy men
Summary
Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. The conventional way to reduce inflammation is to administer anti-inflammatory pharmaceutical agents such as corticosteroids or nonsteroidal anti-inflammatory drugs These drug treatments, often have (severe) side effects or are nonspecific [1,2,3,4]. Psychological interventions aimed at reducing inflammatory processes without the use of pharmaceutical agents could, be useful to supplement, or even (partially) replace current drug treatments. For this reason, it is important to increase our understanding of the effectiveness of psychological interventions on health outcomes. Research on this topic is still in its infancy
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