The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial
Abstract 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 pro...
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doaj-ea6a3f9031e04039a241d91c7891c84a2020-11-24T21:25:19ZengBMCTrials1745-62152017-05-011811910.1186/s13063-017-1983-7The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trialLemmy Schakel0Dieuwke S. Veldhuijzen1Henriët van Middendorp2Corine Prins3Simone A. Joosten4Tom H. M. Ottenhoff5Leo G. Visser6Andrea W. M. Evers7Faculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden UniversityFaculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden UniversityFaculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden UniversityDepartment of Infectious Diseases, Leiden University Medical CentreDepartment of Infectious Diseases, Leiden University Medical CentreDepartment of Infectious Diseases, Leiden University Medical CentreDepartment of Infectious Diseases, Leiden University Medical CentreFaculty of Social and Behavioural Sciences, Institute of Psychology, Health, Medical and Neuropsychology Unit, Leiden UniversityAbstract 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.http://link.springer.com/article/10.1186/s13063-017-1983-7BCG vaccinationImmune systeme-HealthCognitive behavioral therapySerious gamingPsychophysiology |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Lemmy Schakel Dieuwke S. Veldhuijzen Henriët van Middendorp Corine Prins Simone A. Joosten Tom H. M. Ottenhoff Leo G. Visser Andrea W. M. Evers |
spellingShingle |
Lemmy Schakel Dieuwke S. Veldhuijzen Henriët van Middendorp Corine Prins Simone A. Joosten Tom H. M. Ottenhoff Leo G. Visser Andrea W. M. Evers The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial Trials BCG vaccination Immune system e-Health Cognitive behavioral therapy Serious gaming Psychophysiology |
author_facet |
Lemmy Schakel Dieuwke S. Veldhuijzen Henriët van Middendorp Corine Prins Simone A. Joosten Tom H. M. Ottenhoff Leo G. Visser Andrea W. M. Evers |
author_sort |
Lemmy Schakel |
title |
The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial |
title_short |
The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial |
title_full |
The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial |
title_fullStr |
The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial |
title_full_unstemmed |
The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial |
title_sort |
effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2017-05-01 |
description |
Abstract 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. |
topic |
BCG vaccination Immune system e-Health Cognitive behavioral therapy Serious gaming Psychophysiology |
url |
http://link.springer.com/article/10.1186/s13063-017-1983-7 |
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