The effects of a psychological expectancy training directed at optimizing immune functio

Completed

• Conditions: 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.; not applicable

• Registration Number: NL-OMON43991
• Lead Sponsor: niversiteit Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is vitality measured by the composite of the<br /><br>Subjective Vitality Scale and the Checklist Individual Strength after the<br /><br>psychological expectancy training at 6 weeks compared to baseline. </p><br>