- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07702747
The Association Between the Stress Hormone Cortisol and Decision-making
Stress-induced Cortisol Clouds the Gut Feeling in Decision-making: A Randomized Controlled Study
The goal of this study is to learn how acute psychosocial stress influences decision-making in healthy young adults. It will also examine whether cortisol reactivity, a biological stress response, changes the influence of physiological emotional signals on decision-making (i.e., the gut feeling indicating risks).
The main questions it aims to answer are:
- Does exposure to an acute psychosocial stressor affect the development of physiological emotional signals during decision-making?
- Does cortisol reactivity moderate the relationship between physiological emotional signals and decision-making?
- Are there sex differences in these relationships?
Researchers will compare participants exposed to a standardized psychosocial stress procedure, with participants exposed to a non-stressful control condition.
Participants will:
- Be randomly assigned to either a psychosocial stress condition or a control condition.
- Complete a gambling decision-making task following the experimental manipulation.
- Provide multiple saliva samples and subjective stress ratings throughout the session to assess stress reactivity.
- Undergo continuous electrodermal activity recording during the decision-making task to measure physiological emotional signals.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H1N3M5
- Centre de recherche de l'Institut universitaire en santé mentale de Montréal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult aged 18-35 years old.
Exclusion Criteria:
- Current or past psychiatric/neurodevelopmental disorders
- Physical illness
- Medication use (except hormonal contraception)
- Alcohol consumption exceeding Health Canada guidelines (>10 drinks/week for women, >15 for men)
- Smoking more than 7 cigarettes/day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stress condition
Participants completed a slightly modified version of the Trier Social Stress Task (TSST), a validated psychosocial stress induction protocol.
The protocol involved a 10-minute anticipation period followed by a 10-minute test phase: a 5-minute mock job interview and a 5-minute surprise mental arithmetic task.
During the test phase, participants stood in front of a one-way mirror ("Panel-out" version) and were told they were being observed by behavioral analysts and recorded via camera, although no recording took place and the analysts were lab confederates.
|
Participants completed a slightly modified version of the Trier Social Stress Task (TSST), a validated psychosocial stress induction protocol.
The protocol involved a 10-minute anticipation period followed by a 10-minute test phase: a 5-minute mock job interview and a 5-minute surprise mental arithmetic task.
During the test phase, participants stood in front of a one-way mirror ("Panel-out" version) and were told they were being observed by behavioral analysts and recorded via camera, although no recording took place and the analysts were lab confederates.
|
|
No Intervention: Control condition
In the control condition, participants read magazines for an equivalent period of time to the Stress condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decision-making as assessed by the Iowa Gambling Task (probability of drawing from the risky decks vs safe decks)
Time Frame: Immediately after completing the experimental condition (Stress or control condition)
|
Decision-making was assessed using the Iowa Gambling Task.
In this task, participants need to draw 100 cards among 4 decks offering different win-loss contingencies.
Some card decks are risky (large gains and losses), whereas some are safe (small gains and losses).
The dependent variable was a binary variable indicating whether the participant drew a card from the risky (coded as 1) or the safe decks (coded as 0).
|
Immediately after completing the experimental condition (Stress or control condition)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in cortisol levels between the two conditions.
Time Frame: Baseline (just before the experimental condition is conducted), 10, 20, 50, 60, 70 minutes after the beginning of the experimental condition.
|
Cortisol (ug/dL) was quantified for six saliva samples in each condition (Stress or control).
|
Baseline (just before the experimental condition is conducted), 10, 20, 50, 60, 70 minutes after the beginning of the experimental condition.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-2508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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