The primary study objective is to evaluate the psychophysiological effects of a psychological expectancy training directed at optimizing immune function compared to a control group in healthy male subjects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het onderzoek wordt bij gezonde mensen uitgevoerd. Uitkomsten uit deze lijn van onderzoek bieden nieuwe handvatten voor verklaringsmodellen en therapeutische interventies voor gezonde mensen en patiënten met inflammatoire aandoeningen waarbij een verandering in de inflammatoire respons optreedt.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is vitality measured by the composite of the
Subjective Vitality Scale and the Checklist Individual Strength after the
psychological expectancy training at 6 weeks compared to baseline.
Secondary outcome
The following secondary outcomes are assessed:
1) Vitality and well-being at the day of vaccination, at the test day 1 day
after vaccination (10 weeks after the start of the study), and at the follow up
session (14 weeks after the start of the study).
2) Inflammatory responses (e.g., CRP, IL-6, TNF-*) measured in blood at five
time points (at screening, the day of vaccination, twice (start and end of day)
at the test day 1 day after vaccination (10 weeks after the start of the
study), and at the follow up session (14 weeks after the start of the study).
3) LPS stimulated blood at screening, at the day of vaccination and at the
start of the test day 1 day after vaccination.
4) Salivary physiological responses (e.g., cortisol, alpha amylase) measured at
the same time points as the blood samples and additionally after each stress
task 1 day after vaccination (10 weeks after the start of the study).
5) Psychological well-being assessed by NRS scores 1 day after vaccination (at
the start of the test day and after each stress task) and assessed by positive
and negative mood measured at the same time points as the blood samples.
6) Performance on stress tasks (Paced Auditory Serial Addition Task, Cold
Pressor Test, Trier Social Stress Test) assessed at the test day 1 day after
vaccination.
7) Heart rate, heart rate variability and skin conductance are sampled during
screening and during the test day 1 day after vaccination (10 weeks after the
start of the study) and finally during follow up.
Demographic variables, self-reported measures of e.g., personality
characteristics and the 5-HTTLPR genotypes and other candidate genotypes will
be assessed as possible predictors of vitality and inflammatory responses.
Background summary
A previous study revealed that inflammatory reactions to a in-vivo LPS
stimulation can be reduced after an extensive training where psychological
factors and exercise were combined. There is evidence that psychological
interventions alone can also induce anti-inflammatory effects, but studies so
far are small and the effects are inconsistent. Expectancy mechanisms such as
conditioning or verbal suggestions could improve outcomes of psychological
interventions.
Study objective
The primary study objective is to evaluate the psychophysiological effects of a
psychological expectancy training directed at optimizing immune function
compared to a control group in healthy male subjects.
Study design
This randomized trial involves a psychological expectancy training aimed at
improving immune function (experimental group) compared to a control group.
After the screening, subjects are randomized to an online training (including
'serious game' elements) of 6 weeks, supervised by an e-coach, or the control
group that receives no training. This period is followed by the vaccination
with BCG (Bacillus Calmette-Guérin, the current vaccine against tuberculosis),
one day later a test day, and 4 weeks later a follow-up session (14 weeks after
the start of the study).
Intervention
The experimental group will receive a psychological training directed at
optimizing immune function in healthy male subjects.
Study burden and risks
The BCG-vaccine of Intervax is a non-registered vaccine; BCG-vaccins are widely
used throughout the world. It is a live-attenuated vaccine and is
contraindicated for persons with impaired cellular immunity. In view of our
outcome measures BCG will also not be given to persons with a positive
QuantiFERON® -TB Gold In-Tube blood test. In case of a positive QuantiFERON®
-TB Gold In-Tube test, the subject will be counseled by the investigator. The
*Tuberculose bestrijding van GGD Hollands Midden* will be contacted. If the
investigator and/or the GGD think it necessary, the participant will be
referred to this department for further counseling and management.
Most vaccinees will develop a local reaction at the site of injection, which
will heal spontaneously leaving a small scar. Temporary enlargement of regional
lymph nodes is sometimes observed. This does not require treatment. In rare
cases vaccination may lead to disseminated infection with BCG. This condition
requires treatment with isoniazid and rifampicin, to which the vaccine strain
is fully susceptible. Following BCG vaccination future tuberculin skin tests
will show a positive reaction. This means that for participants in this trial
the skin test can no longer be used to screen for tuberculosis. Should the need
arise to test BCG vaccinated individuals for suspected TB, the standard
approach including direct sputum-smear microscopy, chest X-ray radiography and
bacterial culture can still be applied. In addition to this a QuantiFERON® -TB
Gold In-Tube blood test can be performed instead of the skin test.
The risks of drawing blood from a vein include discomfort at the site of
puncture; possible bruising and swelling around the puncture site; rarely an
infection; and, although uncommon, faintness from the procedure. Blood sampling
and vaccination will be performed at the LUMC by trained personnel to avoid
these risks as much as possible.
Burden of study participation is moderate with an expected time investment for
participants of 2 hours for the screening sessions, one hour on the vaccination
day, one test day of four hours and a total of 75 minutes for the five blood
sample sessions (at screening, after the training, twice during the test day 1
day after vaccination, and at follow up (4 weeks after vaccination, 10 weeks
after start training). The training consists of an online training (including
'serious game' elements) during 6 weeks, supervised by an e-coach. This results
in a total time investment of approximately 15 hours for each participant with
a total study duration of 14 weeks per participant. There are no direct
benefits for subjects participating in this study.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
Healthy male adult volunteers between 18 and 35 years of age.
Good understanding of written and spoken Dutch.
Naive for tuberculosis.
Exclusion criteria
History of inflammatory or cardiovascular diseases
Known hypersensitivity or allergy to any of the vaccine components
History exposure to open TB, (latent) TB disease or treatment
BCG vaccination at any time prior to entering the trial
Live vaccination (measles, mumps, rubella, oral polio, oral typhoid, varicella or yellow fever) 4 weeks or less prior to the BCG vaccination
Treatment with immune modulating drugs (systemic steroids, azathioprine, cyclosporine, anti-TNFa, immunoglobulines, cytostatics) 3 months or less prior to enrolment
(History of) disease affecting the lymphoid organs (Hodgkin*s disease, lymphoma, leukaemia, sarcoidosis)
Known congenital or acquired immune deficiencies (e.g. HIV)
Psychiatric (DSM-V) or somatic conditions that interfere with the participant's safety and/or the study protocol (assessed during screening) such as personality disorders, schizophrenia, or haemophilia.
Professional sport player or extreme exercise (assessed during screening)
Excessive drinking or drug use
Active participation in other clinical trials
Not giving consent to inform the participant*s General Practicioner of the BCG vaccination
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52434.058.15 |
| OMON | NL-OMON22144 |