No registrations found.
ID
Source
Brief title
Health condition
Reward sensitivity.
Stress vulnerability.
Healthy volunteers.
Sponsors and support
Intervention
Outcome measures
Primary outcome
In the reward-learning paradigm, the main study parameter is the performance on the computerized task as measured by percentage correct choices of the rewarding stimulus relative to the losing stimuli.
In both the ostracism and the social stress paradigms, the main study parameter is the change in stress scores endorsed by the participants on behavioural questionnaires, as a function of exposure to stressful stimuli. A parallel study parameter is the change in salivary cortisol concentrations as a function of exposure to the stress manipulation.
Secondary outcome
An additional study parameter is the change of stress scores from baseline (baseline) to multiple endpoints (immediately post-study, few hours post-study, the next day, etc) within each individual subject.
Background summary
The primary aim of this study is to validate the paradigms designed to investigate the effects of social stress and social
reward, using healthy individuals. 30 healthy volunteers will be recruited to participate in a single study session lasting approximately 2 hours. Each session will consist of two computerized behavioural experiments, a brief neuropsychological assessment and a number of questionnaires. In order to assess the subjective and objective effects of stress and reward, participants will be asked to periodically fill out a brief questionnaire while chewing on a cotton salivette. The salivettes collect saliva samples that will later be used for analyses of the hormone cortisol. Following the study session, participants will be asked to continue filling out brief questionnaires using a portable electronic device for the duration of 1.5 days.
Study objective
In order to validate the implementation and efficacy of a novel combination of a reward-learning and stress-processing paradigms, we conduct a computerized behavioural pilot study using healthy volunteers. In the reward-learning paradigm, the main study parameter is the difference between percentage choices of the rewarding stimulus over time. In both the ostracism paradigm and the social stress paradigm, the main study parameter is the change in the subjective and objective stress levels from baseline to endpoint.
Study design
One timepoint.
Intervention
N/A
Zuzana Kasanova
Maastricht 6200 MD
The Netherlands
+31 (0)43 3883876
z.kasanova@maastrichtuniversity.nl
Zuzana Kasanova
Maastricht 6200 MD
The Netherlands
+31 (0)43 3883876
z.kasanova@maastrichtuniversity.nl
Inclusion criteria
1. Aged between 18 – 35;
2. Sufficient command of the Dutch language to understand and give informed consent;
3. Mental competence*;
4. Signed informed consent;
5. Somatically, neurologically and mentally healthy state.
Exclusion criteria
1. Current Axis I diagnosis of psychiatric disorder or personality disorder;
2. Current alcohol or substance abuse;
3. Current psychotropic medication use.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3719 |
| NTR-old | NTR3882 |
| CCMO | NL42638.068.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39782 |