State-dependent Interoception, Value-based Decision-making, and Introspection
United States900 participantsStarted 2023-07-25
Plain-language summary
Background:
Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders.
Objective:
To learn how negative emotions affect the brain and decision-making behavior.
Eligibility:
Healthy people aged 18 to 55 years.
Design:
Participants will have 3 clinic visits in 3 weeks.
Participants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind.
For 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor:
Some participants will watch a video.
Some will have to do arithmetic problems.
Some will have heat applied to an arm or leg.
Some will experience cold by immersing their hand in ice water.
For a snack craving test, some will be tempted by food after a 4-hour fast.
During these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected.
After the stressors, participants will do tasks on a computer. They will need to make choices.
Some participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain.
...
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Subject selections will be equitable among those individuals who meet the inclusion criteria. Every effort will be made to balance sex and race. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Ability of subject to understand and the willingness to sign a written informed consent document.
* All sexes; Age 18 to 55.
* Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
For all experiments:
* Unable to comply with study procedures or follow-up visits
* Has any serious or unstable medical condition or history that in a clinician s assessment implies a cardiovascular, neurological, or physical risk from the study procedures performed to induce negative valence states. This may include chronic systemic disorders that could worsen due to stress (e.g. uncontrolled hypertension, coronary artery disease for example a history of myocardial infarction or stable or unstable angina, or diabetes)
* Has any current psychiatric diagnosis (based on SCID or the MINI Mini International Neuropsychiatric Interview) or no diagnosis but scores \>=29 on Beck Depression Inventory II or \>=26 on Beck Anxiety Inventory
* Meets criteria for diagnosis of any substance-related or addictive disorder, or endorses any kind of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.