To test the feasibility of a conditioning paradigm aimed at influencing endogenous cortisol levels and provide data for power calculations for the main study on conditioning of endogenous cortisol and its psychophysiological effects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Op dit moment wordt het onderzoek bij gezonde proefpersonen uitgevoerd. Uitkomsten uit deze lijn van onderzoek bieden in de toekomst mogelijk nieuwe handvatten voor verklaringsmodellen en therapeutische interventies voor aandoeningen waarbij een verstoring in de functie van de HPA-as optreedt.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters of the pilot study are the feasibility of the design
(e.g., most useful assessment points for the psychophysiological assessments,
safety, drop-out). Variance of endogenous cortisol levels at the evocation
phase as well as correlations between cortisol levels at the evocation phase
and at baseline in the experimental group will also be assessed, in order to
enable a founded power analysis for the main study. In the main study, the main
study parameters will be endogenous cortisol levels and psychophysiological
parameters (e.g., in response to cognitive and psychosocial tasks) at the
evocation phase.
Secondary outcome
Not applicable
Background summary
There is preliminary evidence that endogenous cortisol levels might be subject
to manipulation by conditioning, which may have psychophysiological effects.
The ability to condition cortisol can offer new therapeutic possibilities.
However, more systematic research is needed to support these findings.
Study objective
To test the feasibility of a conditioning paradigm aimed at influencing
endogenous cortisol levels and provide data for power calculations for the main
study on conditioning of endogenous cortisol and its psychophysiological
effects.
Study design
A randomized placebo-controlled conditioning paradigm consisting of 2 phases
will be tested.
In the acquisition phase, consisting of 3 sessions on 3 consecutive days, an
association between an unconditioned stimulus (cortisol or placebo pill) and a
conditioned stimulus (novel tasting beverage) will be established. In the
evocation phase, also consisting of 3 sessions on 3 consecutive days a week
after the acquisition phase, all participants will be administered a placebo
pill paired with the same beverage as in the acquisition phase. Cortisol,
alpha-amylase and self-reported wellbeing will be measured at several time
points and heart rate and skin conductance will be monitored continuously
during the 6 acquisition and evocation sessions. At each of these sessions,
participants will also be asked to complete some cognitive and psychosocial
tasks. Successful conditioning would be shown (in the main study) by a
conditioned response (change in endogenous cortisol level) after exposure to
the conditioned stimulus (the beverage paired with a placebo pill) alone.
Additionally, the main study will investigate whether conditioned cortisol
levels have psychophysiological effects.
Intervention
In the experimental group, cortisol levels are elevated exogenously on three
consecutive days by administration of 100 mg hydrocortisone.
Study burden and risks
Participants need to invest 1 hour for the first session and on average 2,5
hours on each following session across 2 weeks. During the acquisition phase,
100 mg of hydrocortisone will be administered to half of the participants on
three consecutive days. Given the short half life of hydrocortisone (8-12
hours) and the fact that only 3 doses are administered, no adverse side effects
are expected (although they will naturally be monitored), especially as this
study is conducted in healthy individuals. Also, all participants will be asked
to perform some cognitive and psychosocial tasks.
Geert Grooteplein 10
Nijmegen 6524 GA
NL
Geert Grooteplein 10
Nijmegen 6524 GA
NL
Listed location countries
Age
Inclusion criteria
healthy, female, premenopausal, 18 - 45 years of age
Exclusion criteria
Severe psychiatric and/or somatic diseases, symptoms of infection, use of medication (including oral contraceptives), recent stressful life event
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40509.091.12 |