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Psychological Training


- candidate number23553
- NTR NumberNTR5610
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2016
- Secondary IDsNL52434.058.15 METC LUMC
- Public TitlePsychological Training
- Scientific TitleThe effects of a psychological training directed at optimizing immune function
- ACRONYMPsychological Training
- hypothesisThe aim of the study is to investigate the effects of a psychological training directed at optimizing immune function in healthy young men. It is expected that the training will lead to improved self-reported vitality (primary hypothesis), both in rest and in response to immunological (BCG vaccination) and psychological and physical stressors.
- Healt Condition(s) or Problem(s) studiedImmune system, Healthy volunteers
- Inclusion criteria1. Male gender
2. Between 18 and 35 years old
3. Good understanding of written and spoken Dutch
4. Naive for tuberculosis
- Exclusion criteria1. History of inflammatory or cardiovascular diseases
2. Known hypersensitivity or allergy to any of the vaccine components
3. History of tuberculosis disease or treatment
4. BCG vaccination at any time prior to entering the trial (asked during screening, indicated by the presence of a scar or as mentioned on the vaccination card)
5. Live vaccination (measles, mumps, rubella, oral polio, oral typhoid or yellow fever) 4 weeks or less prior to the BCG vaccination
6. Treatment with immune modulating drugs 3 months or less prior to enrolment
7. (History of) Disease affecting the lymphoid organs
8. Known congenital or acquired immune deficiencies (e.g., HIV)
9. Psychiatric (DSM-V) or somatic conditions that interfere with the participant's safety and/or the study protocol, such as personality disorders, schizophrenia, or haemophilia
10. Professional sport player or extreme exercise
11. Active participation in other clinical trials
12. Not giving consent to inform the participantís General Practitioner of the BCG vaccination
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jan-2018
- Target number of participants60
- InterventionsThis randomized trial involves a psychological training aimed at optimizing immune function. After screening, subjects are randomized to a training (experimental group) or control condition. The training consists of an internet-delivered guided psychological training, based on cognitive-behavioral principles. The control condition will not receive any training.

The training period is followed by a vaccination with BCG as an immunological stressor.

One day after application of the BCG-vaccination, a test day is planned in which participants will be shortly exposed to psychological and physical stressors.

Finally, a follow-up session is planned at 4 weeks after vaccination.
- Primary outcomeThe primary outcome measure is the difference between the trained and control groups in self-reported vitality directly after the training compared to baseline.
- Secondary outcome1. Vitality and well-being at the day of vaccination, at the test day 1 day after vaccination, and at the follow-up session.
2. Psychological and psychophysiological outcome measures assessed at each measuring point.
- TimepointsThe study consists of 5 sessions during the course of 14 weeks. First of all, participants will be screened for medical and psychological conditions. Thereafter, a training period preceded by a face-to-face intake session with the e-Coach will take place for the participants assigned to the experimental group (week 4 to 10). Afterwards, a vaccination session will take place, immediately followed by a test day (after 10 weeks). Finally, a follow-up session will take place after 14 weeks.
- Trial web siten/a
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. A.W.M. Evers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.W.M. Evers
- Sponsor/Initiator Leiden University
- Funding
(Source(s) of Monetary or Material Support)
European Research Council Consolidator Grant
- Publicationsn/a
- Brief summaryThe main aim of this study is to evaluate the psychophysiological effects of a psychological training aimed at improving immune function in healthy male volunteers. The training consists of an internet-delivered guided psychological training, based on cognitive-behavioral principles. The control condition will not receive any training. A BCG-vaccination will be conducted after 10 weeks. Effects on vitality and other psychological and psychophysiological outcome measures will be examined, both in rest (after 10 and 14 weeks) and in response to stressors (1 day after vaccination).
- Main changes (audit trail)
- RECORD4-jan-2016 - 14-feb-2016


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