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Reward Sensitivity and Stress Vulnerability: A pilot study.


- candidate number14464
- NTR NumberNTR3882
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mrt-2013
- Secondary IDsNL42638.068.13 / 13-3-004; CCMO / METC
- Public TitleReward Sensitivity and Stress Vulnerability: A pilot study.
- Scientific TitleReward Sensitivity and Stress Vulnerability: A pilot study.
- ACRONYMReward&Stress
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers, Stress vulnerability, Reward sensitivity
- Inclusion criteria1. 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 criteria1. Current Axis I diagnosis of psychiatric disorder or personality disorder;
2. Current alcohol or substance abuse;
3. Current psychotropic medication use.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 5-jan-2013
- planned closingdate8-jan-2013
- Target number of participants30
- InterventionsN/A
- Primary outcomeIn 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 outcomeAn 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.
- TimepointsOne timepoint.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Zuzana Kasanova
- CONTACT for SCIENTIFIC QUERIESDrs. Zuzana Kasanova
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
European research Committee
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD5-mrt-2013 - 20-mrt-2013


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